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Comparison of The Routine Respiratory and Gradual Device-guided Slow Breathing Exercises on Inflammation and Heart Rate Variability in Patients With Heart Failure

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# Registration date Revision Id
2 2023-10-31, 1402/08/09 284134
1 2021-12-04, 1400/09/13 207940
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  • Protocol summary

    Comparison of The Routine Respiratory and Gradual Device Guided Slow Breathing Exercises on Inflammation and Heart Rate Variability in Patients With Heart Failure
    Comparison of Routine Respiratory and Gradual Device-guided Slow Breathing Exercises on Inflammation and Heart Rate Variability in Patients With Heart Failure
    The clinical trial had a control group (parallel control groups), one-way blind, randomly selected with a Concealed envelope, and on 24 patients with chronic heart failure.
    The clinical trial has a control group, is single-blind, randomly selected with a concealed envelope, and is on 36 patients with chronic heart failure.
    کارآزمایی بالینی دارای گروه کنترل (گروه کنترل موازی)، یک سویه کور، تصادفی شده به وسیله پاکت مهمروموم شده و بر روی 24 بیمار مبتلا به نارسایی مزمن قلبی است.
    کارآزمایی بالینی دارای گروه کنترل، یک سویه کور، تصادفی شده به وسیله پاکت مهمروموم شده و بر روی 36 بیمار مبتلا به نارسایی مزمن قلبی است.
    The study site is Emam Reza Educational, Research and Treatment Center in Mashhad. Patients and physicians have been blinded. Informed consent, six-minute Walk test, blood pressure measurement, ECG Holter monitor, and lipid profile test and TNF alpha are taken from all samples.
    The study location is Emam Reza Educational, Research, and Treatment Center in Mashhad. Patients and physicians have been blinded. Informed consent, a six-minute walk test, blood pressure measurement, an ECG Holter monitor, a lipid profile test, and TNF alpha are taken from all samples.
    Among the patients with chronic heart failure referred to Emam Reza Educational, Research and Treatment Center in the age range of 50 to 70 years and with an ejection fraction of less than 50%, they are selected by available sampling method.
    Among the patients with chronic heart failure referred to Emam Reza Educational, Research, and Treatment Center in the age range of 50 to 70 years and with an ejection fraction of less than 50%, they are selected by the available sampling method.
    In this study, there are two groups that the samples have parallel control for four weeks. The samples are then simple randomly placed in one of the two intervention groups using a Concealed envelope . Group 1: Individuals perform routine breathing exercises. Group 2: Individuals perform gradual slow breathing exercises guided by a Persia respirometer.
    There are three groups in this study. Using a concealed envelope, the samples are simply randomly assigned to one of three groups. Group 1: Individuals only receive standard medication treatment. Group 2: Individuals In addition to standard medication treatment, perform routine breathing exercises. Group 3: Individuals In addition to standard medication treatment, perform gradual, slow breathing exercises guided by a respirometer Biofeedback.
    در این تحقيق دو گروه وجود دارد که نمونه‌ها داراي كنترل موازي به مدت چهار هفته هستند. پس از آن نمونه ها به روش تصادفي ساده و با استفاده از پاکت مهروموم شده دریکی از دو گروه مداخله زير قرار می‌گیرند. گروه ۱: افراد تمرینات روتین تنفسی را انجام می دهند. گروه ۲: افراد تمرینات تنفسی آهسته تدریجی هدایت‌شده را توسط دستگاه رسپیرومتر پرشیا انجام می دهند.
    در این تحقيق سه گروه وجود دارد. نمونه ها به روش تصادفي ساده و با استفاده از پاکت مهروموم شده در یکی از سه گروه قرار می‌گیرند. گروه 1: افراد فقط درمان دارویی استاندارد را دریافت می کنند. گروه 2: افراد علاوه بر درمان دارویی استاندارد، تمرینات روتین تنفسی را انجام می دهند. گروه 3: افراد علاوه بر درمان دارویی استاندارد، تمرینات تنفسی آهسته تدریجی هدایت‌شده را توسط دستگاه رسپیرومتر بیوفیدبک انجام می دهند.

  • General information

    24
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    2022-09-22, 1401/06/31
    2023-04-20, 1402/01/31
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    2022-01-08, 1400/10/18
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    2023-02-13, 1401/11/24
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    2023-03-13, 1401/12/22
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    increasing the sample size The description of the control group was modified, where subjects received only standard drug treatment. recording the completion of the sample Recording the date of the end of the study Changing the status of the responsible person
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    افزایش حجم نمونه ویرایش توضیح گروه کنترل که این افراد تنها درمان دارویی استاندارد را دریافت کردند. ثبت اتمام نمونه گیری ثبت تاریخ پایان مطالعه تغییر موقعیت مقام مسئول
    Comparison of The Routine Respiratory and Gradual Device Guided Slow Breathing Exercises on Inflammation and Heart Rate Variability in Patients With Heart Failure
    Comparison of The Routine Respiratory and Gradual Device-guided Slow Breathing Exercises on Inflammation and Heart Rate Variability in Patients With Heart Failure
    Comparison of The Routine Respiratory and Gradual Device Guided Slow Breathing Exercises on Inflammation and Heart Rate Variability in Patients With Heart Failure
    Comparison of The Routine Respiratory and Gradual Device-guided Slow Breathing Exercises on Inflammation and Heart Rate Variability in Patients With Heart Failure
    Class II and III heart failure based on NYHA criteria
    Having heart failure for 3-5 years
    Clinical status, stable hemodynamics at least one month before entering the study
    Ejection fraction less than 50% based on echocardiography
    Being treated with standard medication
    Age range 50 to 70 years
    Class II and III heart failure based on NYHA criteria
    Having suffered from heart failure for the past 3–5 years
    Clinical status and stable hemodynamics at least one month before entering the study
    Ejection fraction less than 50% based on echocardiography
    Being treated with standard medication
    Age range: 50 to 70 years
    Unstable angina and complex ventricular arrhythmias
    Occurrence of myocardial infarction in the past year
    having pacemaker
    Perform bypass surgery or angioplasty during the last six months
    Participate in other exercise programs six months before the start of the study
    Existence of musculoskeletal disorders that prevent normal walking
    Existence of cognitive disorders
    Lack of personal desire to cooperate
    History of lung disease, smoking, angina, heart attack or heart surgery (less than six months), orthopedic or neurological diseases, steroid therapy or chemotherapy
    Unstable angina and complex ventricular arrhythmias
    The occurrence of myocardial infarction in the past year
    having pacemaker
    During the last six months, have bypass surgery or angioplasty.
    Participate in other exercise programs six months before the start of the study.
    The existence of musculoskeletal disorders that prevent normal walking
    Existence of cognitive disorders
    Lack of personal desire to cooperate
    History of lung disease, smoking, angina, heart attack or heart surgery (less than six months), orthopedic or neurological diseases, steroid therapy, or chemotherapy
    Design and construction of Persia respirometer biofeedback device for respiratory training of the subjects
    Design and construction of a respirometer biofeedback device for respiratory training of the subjects
    طراحی و ساخت دستگاه بیوفیدبک رسپیرومتر پرشیا جهت تمرین تنفسی افراد مورد مطالعه
    طراحی و ساخت دستگاه رسپیرومتر بیوفیدبک جهت تمرین تنفسی افراد مورد مطالعه
    The present study is a one-way blinded controlled clinical trial, cardiologist and patients are not aware of being in the intervention or control group.
    The present study is a one-way blinded controlled clinical trial, and the cardiologist and patients are not aware of being in the intervention or control group.

  • Primary outcomes

    #1
    Basic respiration rate
    The basic rate of respiration
    One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
    48 hours before the intervention and 48 hours after the end of four weeks of intervention
    يك ماه قبل از شروع مداخله، 48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    Average rate of five minutes of respiration based on Persia respirometer
    Average rate of five minutes of respiration based on respirometer biofeedback.
    ميانگين نرخ پنج دقيقه تنفس بر اساس دستگاه رسپيرومتر پرشيا
    ميانگين نرخ پنج دقيقه تنفس بر اساس دستگاه بیوفیدبک رسپيرومتر
    #2
    One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
    48 hours before the intervention and 48 hours after the end of four weeks of intervention
    يك ماه قبل از شروع مداخله، 48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    According to the report of TNF alpha in enzyme-linked immunosorbent assay
    According to the report of TNF-alpha in an enzyme-linked immunosorbent assay device
    #3
    heart rate variability
    Heart Rate Variability
    One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
    48 hours before the intervention and 48 hours after the end of four weeks of intervention
    يك ماه قبل از شروع مداخله، 48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله

  • Secondary outcomes

    #1
    One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
    48 hours before the intervention and 48 hours after the end of four weeks of intervention
    يك ماه قبل از شروع مداخله، 48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    #2
    One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
    48 hours before the intervention and 48 hours after the end of four weeks of intervention
    يك ماه قبل از شروع مداخله، 48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    From a person's blood serum based on the report of an autoanalyzer
    Based on an autoanalyzer device's report from a person's blood serum
    #3
    One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
    48 hours before the intervention and 48 hours after the end of four weeks of intervention
    يك ماه قبل از شروع مداخله، 48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    From a person's blood serum based on the report of an autoanalyzer
    From a person's blood serum based on the report of an autoanalyzer device
    #4
    high-density lipoprotein (HDL)
    High-Density Lipoprotein (HDL)
    One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
    48 hours before the intervention and 48 hours after the end of four weeks of intervention
    يك ماه قبل از شروع مداخله، 48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    From a person's blood serum based on the report of an autoanalyzer
    From a person's blood serum based on the report of an autoanalyzer device
    #5
    low-density lipoprotein (LDL)
    Low-Density Lipoprotein (LDL)
    One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
    48 hours before the intervention and 48 hours after the end of four weeks of intervention
    يك ماه قبل از شروع مداخله، 48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    From a person's blood serum based on the report of an autoanalyzer
    From a person's blood serum based on the report of an autoanalyzer device
    #6
    One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
    48 hours before the intervention and 48 hours after the end of four weeks of intervention
    يك ماه قبل از شروع مداخله، 48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    According to average Holter blood pressure report
    According to the average Holter blood pressure report
    #7
    One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
    48 hours before the intervention and 48 hours after the end of four weeks of intervention
    يك ماه قبل از شروع مداخله، 48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    According to average Holter blood pressure report
    According to the average Holter blood pressure report
    #8
    One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
    48 hours before and after the six-minute walk test and 48 hours after the end of four weeks of intervention before and after the six-minute walk test
    يك ماه قبل از شروع مداخله، 48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    48 ساعت قبل از شروع مداخله قبل و بعد آزمون شش دقیقه راه رفتن و 48 ساعت پس از اتمام چهار هفته از مداخله قبل و بعد آزمون شش دقیقه راه رفتن
    #9
    standard deviation of NN intervals (SDNN)
    Standard Deviation of NN Intervals (SDNN)
    One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
    48 hours before the intervention and 48 hours after the end of four weeks of intervention
    يك ماه قبل از شروع مداخله، 48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    According to the report of cardiac Holter device
    According to the report of the cardiac Holter device
    #10
    root mean square of successive differences between normal heartbeats (RMSSD)
    Root Mean Square of Successive Differences between normal heartbeats (RMSSD)
    One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
    48 hours before the intervention and 48 hours after the end of four weeks of intervention
    يك ماه قبل از شروع مداخله، 48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    According to the report of cardiac Holter device
    According to the report of the cardiac Holter device
    #11
    The percentage of adjacent NN intervals that differ from each other by more than 50 ms (pNN50)
    The Percentage of adjacent NN intervals that differ from each other by more than 50 ms (pNN50)
    One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
    48 hours before the intervention and 48 hours after the end of four weeks of intervention
    يك ماه قبل از شروع مداخله، 48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    According to the report of cardiac Holter device
    According to the report of the cardiac Holter device
    #12
    Functional capacity
    Physical Functional Performance
    One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
    48 hours before the intervention and 48 hours after the end of four weeks of intervention
    يك ماه قبل از شروع مداخله، 48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    48 ساعت قبل از شروع مداخله و 48 ساعت پس از اتمام چهار هفته از مداخله
    Based on a 6-minute walk test
    Based on the 6-Minute Walk Test (6MWT)

  • Intervention groups

    #1
    N/A
    Treatment - Drugs
    Control group: It is parallel. Each sample has its own control one month before the intervention.
    Control group: Individuals only receive standard medication treatment.
    گروه کنترل: موازي است. هر نمونه به يك ماه قبل از مداخله كنترل خودش مي باشد.
    گروه کنترل: افراد فقط درمان دارویی استاندارد را دریافت می کنند.
    #2
    Intervention group: In the first group or routine breathing exercises group: For four weeks, in the first week for 20 minutes and with an increase of 3.5 minutes at the beginning of the second, third and fourth weeks, in the fourth week for 30 minutes the person does these exercises. The patient is asked to lean back in the chair and sit in a comfortable chair. The patient then holds a incentive spirometry in his hand and, after a normal exhalation ,places the spirometry mouthpiece in his or her mouth and performs inhalation slowly and deeply as much as possible. The patient performs this operation three times at the beginning of each week and its average is recorded as the maximum respiratory capacity. The patient is then asked to perform a deep breathing exercise with 60% of the base volume obtained. This exercise is given twice a day, 10 times each time, and 30 to 60 seconds of rest between each exercise. At the beginning of each week, 2 exercises will be added to the exercises, so that at the end of the fourth week, this exercise will be performed 16 times.
    Intervention group; in the second group, or Routine Breathing Exercises group, for four weeks, in the first week for 20 minutes, and with an increase of 3.5 minutes at the beginning of the second, third, and fourth weeks, in the fourth week for 30 minutes, the person does these exercises. The patient is asked to lean back in the chair and sit in a comfortable chair. The patient then holds an incentive spirometry in his hand and, after a normal exhalation, places the spirometry mouthpiece in his or her mouth and performs inhalation slowly and deeply as much as possible. The patient performs this operation three times at the beginning of each week, and its average is recorded as the maximum respiratory capacity. The patient is then asked to perform a deep breathing exercise with 60% of the base volume obtained. This exercise is given twice a day, 10 times each time, with 30 to 60 seconds of rest between each exercise. At the beginning of each week, two exercises will be added to the exercises, so that at the end of the fourth week, this exercise will be performed 16 times.
    گروه مداخله: در گروه اول يا گروه تمرينات روتين تنفسي: به مدت چهار هفته، در هفته اول به مدت 20 دقیقه و با افزایش 3.5 دقیقه در شروع هفته های دوم، سوم و چهارم که در هفته چهارم به مدت 30 دقیقه فرد این تمرینات را انجام مي دهد. از بیمار خواسته می شود که به پشت صندلی تکیه داده و بر روی صندلی آرام بنشیند. سپس بیمار اسپیرومتری انگیزشی را در دست خود نگه داشته و پس از یک بازدم معمولی، قطعه دهانی اسپیرومتری را در دهان خود قرار داده و به صورت آهسته و عمیق عمل دم را تا حداکثر جایی که ممکن است انجام می دهد. بیمار این عمل را در ابتدای هر هفته، سه مرتبه انجام داده و میانگین آن به عنوان حداکثر ظرفیت تنفسي ثبت می شود. سپس از بیمار خواسته می شود تمرین تنفس عمیق را با 60 درصد حجم مبنای بدست آمده انجام دهد. این تمرین دو بار در روز و هر بار 10 مرتبه و بین هر تمرین نیز 30 تا 60 ثانیه استراحت داده می‌شود. در ابتدای هر هفته تعداد 2 تمرین به تمرینات افزوده می‌شود به صورتی که در انتهای هفته چهارم این تمرین 16 مرتبه انجام خواهد شد.
    گروه مداخله؛ گروه دوم يا گروه تمرينات روتين تنفسي: به مدت چهار هفته، در هفته اول به مدت 20 دقیقه و با افزایش 3.5 دقیقه در شروع هفته های دوم، سوم و چهارم که در هفته چهارم به مدت 30 دقیقه فرد این تمرینات را انجام مي دهد. از بیمار خواسته می شود که به پشت صندلی تکیه داده و بر روی صندلی آرام بنشیند. سپس بیمار اسپیرومتری انگیزشی را در دست خود نگه داشته و پس از یک بازدم معمولی، قطعه دهانی اسپیرومتری را در دهان خود قرار داده و به صورت آهسته و عمیق عمل دم را تا حداکثر جایی که ممکن است انجام می دهد. بیمار این عمل را در ابتدای هر هفته، سه مرتبه انجام داده و میانگین آن به عنوان حداکثر ظرفیت تنفسي ثبت می شود. سپس از بیمار خواسته می شود تمرین تنفس عمیق را با 60 درصد حجم مبنای بدست آمده انجام دهد. این تمرین دو بار در روز و هر بار 10 مرتبه و بین هر تمرین نیز 30 تا 60 ثانیه استراحت داده می‌شود. در ابتدای هر هفته تعداد 2 تمرین به تمرینات افزوده می‌شود به صورتی که در انتهای هفته چهارم این تمرین 16 مرتبه انجام خواهد شد.
    #3
    Intervention group: In the second group or gradual device guided slow breathing exercises, in the first week for 20 minutes and with an increase of 3.5 minutes at the beginning of the second, third and fourth weeks, which in the fourth week for 30 minutes. Under the guidance of Persia Respirator, observing the overload principle, a total reduction of 50% of the respiratory rate is applied, which in four stages is 12.5% compared to the basic respiratory rate, which is measured at the beginning of each week. The basal rate of respiration and the rate of decrease in the rate of respiration relative to the basal rate obtained at the beginning of each week are recorded and reported for each individual.
    Intervention group, In the third group, or Gradual Device-guided Slow Breathing Exercises, for four weeks, in the first week for 20 minutes, and with an increase of 3.5 minutes at the beginning of the second, third, and fourth weeks, in the fourth week for 30 minutes. Under the guidance of Respirometer Biofeedback, observing the overload principle, a total reduction of 50% of the respiratory rate is applied, which in four stages is 12.5% compared to the basic respiratory rate, which is measured at the beginning of each week. The basal rate of respiration and the rate of decrease in the rate of respiration relative to the basal rate obtained at the beginning of each week are recorded and reported for each individual.
    گروه مداخله: در گروه دوم یا تمرینات تنفسي آهسته تدریجی هدایت‌شده توسط دستگاه در هفته اول به مدت 20 دقیقه و با افزایش 3.5 دقیقه در ابتدای هفته‌های دوم، سوم و چهارم که در هفته چهارم به مدت ۳۰ دقیقه با راهنمایی دستگاه رسپیرومتر پرشیا با رعایت اصل اورلود کاهش کلی 50 درصد نرخ تنفس که در چهار مرحله 12.5 درصدی نسبت به نرخ تنفس پایه‌ای که در ابتدای هر هفته اندازه‌‌گیری می‌شود،اعمال می گردد. نرخ پایه تنفس و میزان کاهش نرخ تنفس نسبت به نرخ پایه بدست آمده در ابتدای هر هفته برای هر فرد ثبت و گزارش می شود.
    گروه مداخله؛ گروه سوم یا تمرینات تنفسي آهسته تدریجی هدایت‌شده توسط دستگاه: به مدت چهار هفته، در هفته اول به مدت 20 دقیقه و با افزایش 3.5 دقیقه در ابتدای هفته‌های دوم، سوم و چهارم که در هفته چهارم به مدت ۳۰ دقیقه با راهنمایی دستگاه رسپیرومتر پرشیا با رعایت اصل اورلود کاهش کلی 50 درصد نرخ تنفس که در چهار مرحله 12.5 درصدی نسبت به نرخ تنفس پایه‌ای که در ابتدای هر هفته اندازه‌‌گیری می‌شود،اعمال می گردد. نرخ پایه تنفس و میزان کاهش نرخ تنفس نسبت به نرخ پایه بدست آمده در ابتدای هر هفته برای هر فرد ثبت و گزارش می شود.

  • Recruitment centers

    #1
    Name of recruitment center - English: Emam Reza Educational, Research and Treatment Center
    Name of recruitment center - Persian: مجتمع آموزشي،پ‍ژوهشي و درماني امام رضا (ع)
    Full name of responsible person - English: Farveh Vakilian
    Full name of responsible person - Persian: فروه وكيليان
    Street address - English: Emam Reza Educational, Research and Treatment Center - Imam Reza Square
    Street address - Persian: میدان بیمارستان امام رضا(ع)، مرکز آموشی پژوهشی و درمانی امام رضا (ع)
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9137913316
    Phone: +98 51 3854 3031
    Fax: +98 51 3859 1057
    Email: IRH@mums.ac.ir
    Web page address: https://emamreza.mums.ac.ir/
    Name of recruitment center - English: Emam Reza Educational, Research, and Treatment Center
    Name of recruitment center - Persian: مجتمع آموزشي،پ‍ژوهشي و درماني امام رضا (ع)
    Full name of responsible person - English: Farveh Vakilian
    Full name of responsible person - Persian: فروه وكيليان
    Street address - English: Emam Reza Educational, Research, and Treatment Center, Imam Reza Square
    Street address - Persian: میدان بیمارستان امام رضا(ع)، مرکز آموشی پژوهشی و درمانی امام رضا (ع)
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9137913316
    Phone: +98 51 3854 3031
    Fax: +98 51 3859 1057
    Email: IRH@mums.ac.ir
    Web page address: https://emamreza.mums.ac.ir

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Farhad Daneshjoo
    Full name of responsible person - Persian: فرهاد دانشجو
    Street address - English: Nasr -Jalal AleAhmad- Tehran
    Street address - Persian: تهران جلال آل احمد پل نصر
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411713116
    Phone: +98 21 8288 2005
    Fax:
    Email: mahmadi@modares.ac.ir
    Web page address: https://www.modares.ac.ir/
    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Farhad Daneshjoo
    Full name of responsible person - Persian: فرهاد دانشجو
    Street address - English: Nasr, Jalal AleAhmad, Tehran
    Street address - Persian: تهران جلال آل احمد پل نصر
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411713116
    Phone: +98 21 8288 2005
    Fax:
    Email: pres@modares.ac.ir
    Web page address: https://www.modares.ac.ir

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Roya ravanbod
    Full name of responsible person - Persian: رويا روانبد
    Position - English: Assistant professor
    Position - Persian: استاديار
    Latest degree: phd
    Area of specialty/work:
    Area of specialty/work title - English: Physical therapy
    Area of specialty/work title - Persian: فيزيوتراپي
    Street address - English: Nasr, Jalal AleAhmad, Tehran
    Street address - Persian: تهران جلال آل احمد پل نصر
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1411713116
    Phone: +98 21 8288 4510
    Mobile: +98 912 240 6624
    Fax:
    Email: ravanbod@modares.ac.ir
    Web page address: https://www.modares.ac.ir/pro/academic_staff/ravanbod
    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Roya ravanbod
    Full name of responsible person - Persian: رويا روانبد
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work:
    Area of specialty/work title - English: Physical therapy
    Area of specialty/work title - Persian: فيزيوتراپي
    Street address - English: Nasr, Jalal AleAhmad, Tehran
    Street address - Persian: تهران جلال آل احمد پل نصر
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1411713116
    Phone: +98 21 8288 4510
    Mobile: +98 912 240 6624
    Fax:
    Email: ravanbod@modares.ac.ir
    Web page address: https://www.modares.ac.ir/pro/academic_staff/ravanbod

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Roya ravanbod
    Full name of responsible person - Persian: رويا روانبد
    Position - English: Assistant professor
    Position - Persian: استاديار
    Latest degree: phd
    Area of specialty/work:
    Area of specialty/work title - English: Physical therapy
    Area of specialty/work title - Persian: فيزيوتراپي
    Street address - English: Nasr, Jalal AleAhmad, Tehran
    Street address - Persian: تهران جلال آل احمد پل نصر
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1411713116
    Phone: +98 21 8288 4510
    Mobile: +98 912 240 6624
    Fax:
    Email: ravanbod@modares.ac.ir
    Web page address: https://www.modares.ac.ir/pro/academic_staff/ravanbod
    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Roya ravanbod
    Full name of responsible person - Persian: رويا روانبد
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work:
    Area of specialty/work title - English: Physical therapy
    Area of specialty/work title - Persian: فيزيوتراپي
    Street address - English: Nasr, Jalal AleAhmad, Tehran
    Street address - Persian: تهران جلال آل احمد پل نصر
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1411713116
    Phone: +98 21 8288 4510
    Mobile: +98 912 240 6624
    Fax:
    Email: ravanbod@modares.ac.ir
    Web page address: https://www.modares.ac.ir/pro/academic_staff/ravanbod

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Mahdi Rahmati-Yami
    Full name of responsible person - Persian: مهدی رحمتی یامی
    Position - English: PhD Candidate
    Position - Persian: دانشجوي دکتری تخصصی
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Unit 4, Floor 2, NO 1, Fadjr 11 Alley, Sahedi 5 St, Sajedi Blvd, Mashhad, Razavi Khorasan Province, Iran
    Street address - Persian: ایران، استان خراسان رضوی، شهرستان مشهد، بلوار ساجدی، ساجدی 5، نبش فجر 11، پلاک 1، طبقه دوم، واحد 4
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9197847442
    Phone: +98 51 3760 5302
    Mobile: +98 915 559 8859
    Fax:
    Email: mahdi.rahmati@modares.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Mahdi Rahmati-Yami
    Full name of responsible person - Persian: مهدی رحمتی یامی
    Position - English: PhD Candidate
    Position - Persian: دانشجوي دکتری تخصصی
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Unit 4, Floor 2, NO 1, Fadjr 11 Alley, Sahedi 5 St., Sajedi Blvd., Mashhad, Razavi Khorasan Province, Iran
    Street address - Persian: ایران، استان خراسان رضوی، شهرستان مشهد، بلوار ساجدی، ساجدی 5، نبش فجر 11، پلاک 1، طبقه دوم، واحد 4
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9197847442
    Phone: +98 51 3760 5302
    Mobile: +98 915 559 8859
    Fax:
    Email: mahdi.rahmati@modares.ac.ir
    Web page address:

  • Sharing plan

    6 months after publication
    8 months after publication
    6 ماه پس از چاپ
    8 ماه پس از چاپ
    رويا روانبد Tarbiat Modares University ravanbod@modares.ac.ir https://www.modares.ac.ir/pro/academic_staff/ravanbod
    Roya Ravanbod Tarbiat Modares University ravanbod@modares.ac.ir https://www.modares.ac.ir/pro/academic_staff/ravanbod

Protocol summary

Study aim
Comparison of Routine Respiratory and Gradual Device-guided Slow Breathing Exercises on Inflammation and Heart Rate Variability in Patients With Heart Failure
Design
The clinical trial has a control group, is single-blind, randomly selected with a concealed envelope, and is on 36 patients with chronic heart failure.
Settings and conduct
The study location is Emam Reza Educational, Research, and Treatment Center in Mashhad. Patients and physicians have been blinded. Informed consent, a six-minute walk test, blood pressure measurement, an ECG Holter monitor, a lipid profile test, and TNF alpha are taken from all samples.
Participants/Inclusion and exclusion criteria
Among the patients with chronic heart failure referred to Emam Reza Educational, Research, and Treatment Center in the age range of 50 to 70 years and with an ejection fraction of less than 50%, they are selected by the available sampling method.
Intervention groups
There are three groups in this study. Using a concealed envelope, the samples are simply randomly assigned to one of three groups. Group 1: Individuals only receive standard medication treatment. Group 2: Individuals In addition to standard medication treatment, perform routine breathing exercises. Group 3: Individuals In addition to standard medication treatment, perform gradual, slow breathing exercises guided by a respirometer Biofeedback.
Main outcome variables
Basic respiration rate; Inflammation; Heart Rate Variability

General information

Reason for update
increasing the sample size The description of the control group was modified, where subjects received only standard drug treatment. recording the completion of the sample Recording the date of the end of the study Changing the status of the responsible person
Acronym
IRCT registration information
IRCT registration number: IRCT20210426051093N1
Registration date: 2021-12-04, 1400/09/13
Registration timing: prospective

Last update: 2023-11-04, 1402/08/13
Update count: 1
Registration date
2021-12-04, 1400/09/13
Registrant information
Name
Mahdi Rahmati-Yami
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 51 3760 5302
Email address
mahdi.rahmati@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
2022-01-08, 1400/10/18
Actual recruitment end date
2023-02-13, 1401/11/24
Trial completion date
2023-03-13, 1401/12/22
Scientific title
Comparison of The Routine Respiratory and Gradual Device-guided Slow Breathing Exercises on Inflammation and Heart Rate Variability in Patients With Heart Failure
Public title
Comparison of The Routine Respiratory and Gradual Device-guided Slow Breathing Exercises on Inflammation and Heart Rate Variability in Patients With Heart Failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Class II and III heart failure based on NYHA criteria Having suffered from heart failure for the past 3–5 years Clinical status and stable hemodynamics at least one month before entering the study Ejection fraction less than 50% based on echocardiography Being treated with standard medication Age range: 50 to 70 years
Exclusion criteria:
Unstable angina and complex ventricular arrhythmias The occurrence of myocardial infarction in the past year having pacemaker During the last six months, have bypass surgery or angioplasty. Participate in other exercise programs six months before the start of the study. The existence of musculoskeletal disorders that prevent normal walking Existence of cognitive disorders Lack of personal desire to cooperate History of lung disease, smoking, angina, heart attack or heart surgery (less than six months), orthopedic or neurological diseases, steroid therapy, or chemotherapy
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 36
Actual sample size reached: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly assigned to one of the groups by a researcher using a Concealed envelope method.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is a one-way blinded controlled clinical trial, and the cardiologist and patients are not aware of being in the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Design and construction of a respirometer biofeedback device for respiratory training of the subjects

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tarbiat Modares University Ethics Committee
Street address
Tehran Jalal AleAhmad Nasr
City
Tehran
Province
Tehran
Postal code
14115111
Approval date
2021-10-23, 1400/08/01
Ethics committee reference number
IR.MODARES.REC.1400.200

Health conditions studied

1

Description of health condition studied
Chronic heart Failure
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
The basic rate of respiration
Timepoint
48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
Average rate of five minutes of respiration based on respirometer biofeedback.

2

Description
Inflammation
Timepoint
48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
According to the report of TNF-alpha in an enzyme-linked immunosorbent assay device

3

Description
Heart Rate Variability
Timepoint
48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
Holter monitoring device

Secondary outcomes

1

Description
Quality of Life
Timepoint
48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
Minnesota Quality of Life Questionnaire Score

2

Description
Cholesterol
Timepoint
48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
Based on an autoanalyzer device's report from a person's blood serum

3

Description
Triglyceride
Timepoint
48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
From a person's blood serum based on the report of an autoanalyzer device

4

Description
High-Density Lipoprotein (HDL)
Timepoint
48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
From a person's blood serum based on the report of an autoanalyzer device

5

Description
Low-Density Lipoprotein (LDL)
Timepoint
48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
From a person's blood serum based on the report of an autoanalyzer device

6

Description
Systolic blood pressure at rest
Timepoint
48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
According to the average Holter blood pressure report

7

Description
Diastolic blood pressure at rest
Timepoint
48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
According to the average Holter blood pressure report

8

Description
Rate of perceived exertion
Timepoint
48 hours before and after the six-minute walk test and 48 hours after the end of four weeks of intervention before and after the six-minute walk test
Method of measurement
Based on the Borg scale

9

Description
Standard Deviation of NN Intervals (SDNN)
Timepoint
48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
According to the report of the cardiac Holter device

10

Description
Root Mean Square of Successive Differences between normal heartbeats (RMSSD)
Timepoint
48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
According to the report of the cardiac Holter device

11

Description
The Percentage of adjacent NN intervals that differ from each other by more than 50 ms (pNN50)
Timepoint
48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
According to the report of the cardiac Holter device

12

Description
Physical Functional Performance
Timepoint
48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
Based on the 6-Minute Walk Test (6MWT)

Intervention groups

1

Description
Control group: Individuals only receive standard medication treatment.
Category
Treatment - Drugs

2

Description
Intervention group; in the second group, or Routine Breathing Exercises group, for four weeks, in the first week for 20 minutes, and with an increase of 3.5 minutes at the beginning of the second, third, and fourth weeks, in the fourth week for 30 minutes, the person does these exercises. The patient is asked to lean back in the chair and sit in a comfortable chair. The patient then holds an incentive spirometry in his hand and, after a normal exhalation, places the spirometry mouthpiece in his or her mouth and performs inhalation slowly and deeply as much as possible. The patient performs this operation three times at the beginning of each week, and its average is recorded as the maximum respiratory capacity. The patient is then asked to perform a deep breathing exercise with 60% of the base volume obtained. This exercise is given twice a day, 10 times each time, with 30 to 60 seconds of rest between each exercise. At the beginning of each week, two exercises will be added to the exercises, so that at the end of the fourth week, this exercise will be performed 16 times.
Category
Rehabilitation

3

Description
Intervention group, In the third group, or Gradual Device-guided Slow Breathing Exercises, for four weeks, in the first week for 20 minutes, and with an increase of 3.5 minutes at the beginning of the second, third, and fourth weeks, in the fourth week for 30 minutes. Under the guidance of Respirometer Biofeedback, observing the overload principle, a total reduction of 50% of the respiratory rate is applied, which in four stages is 12.5% compared to the basic respiratory rate, which is measured at the beginning of each week. The basal rate of respiration and the rate of decrease in the rate of respiration relative to the basal rate obtained at the beginning of each week are recorded and reported for each individual.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza Educational, Research, and Treatment Center
Full name of responsible person
Farveh Vakilian
Street address
Emam Reza Educational, Research, and Treatment Center, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Fax
+98 51 3859 1057
Email
IRH@mums.ac.ir
Web page address
https://emamreza.mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Farhad Daneshjoo
Street address
Nasr, Jalal AleAhmad, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2005
Email
pres@modares.ac.ir
Web page address
https://www.modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Roya ravanbod
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical therapy
Street address
Nasr, Jalal AleAhmad, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4510
Email
ravanbod@modares.ac.ir
Web page address
https://www.modares.ac.ir/pro/academic_staff/ravanbod

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Roya ravanbod
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical therapy
Street address
Nasr, Jalal AleAhmad, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4510
Email
ravanbod@modares.ac.ir
Web page address
https://www.modares.ac.ir/pro/academic_staff/ravanbod

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mahdi Rahmati-Yami
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Unit 4, Floor 2, NO 1, Fadjr 11 Alley, Sahedi 5 St., Sajedi Blvd., Mashhad, Razavi Khorasan Province, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9197847442
Phone
+98 51 3760 5302
Fax
Email
mahdi.rahmati@modares.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data
When the data will become available and for how long
8 months after publication
To whom data/document is available
researchers
Under which criteria data/document could be used
For medical and research purposes
From where data/document is obtainable
Roya Ravanbod Tarbiat Modares University ravanbod@modares.ac.ir https://www.modares.ac.ir/pro/academic_staff/ravanbod
What processes are involved for a request to access data/document
Approval of supervisors
Comments
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