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IRCT20210426051093N1 IRCT 2021-12-04 Tarbiat Modares University 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 2021-12-11 anticipated 36 Complete https://irct.ir/trial/55869 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Design and construction of a respirometer biofeedback device for respiratory training of the subjects, Randomization description: Individuals are randomly assigned to one of the groups by a researcher using a Concealed envelope method, 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. N/A Chronic heart Failure. Intervention 1: Control group: Individuals only receive standard medication treatment. Intervention 2: 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. Intervention 3: 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. Yes - There is a plan to make this available What will be shared: Part of the data When: 8 months after publication To whom: researchers Conditions: For medical and research purposes Where to obtain: Roya Ravanbod Tarbiat Modares University ravanbod@modares.ac.ir https://www.modares.ac.ir/pro/academic_staff/ravanbod How to obtain: Approval of supervisors Comments:
public Roya ravanbod
Nasr, Jalal AleAhmad, Tehran
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 4510 ravanbod@modares.ac.ir Tarbiat Modares University scientific Roya ravanbod
Nasr, Jalal AleAhmad, Tehran
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 4510 ravanbod@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) 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 50 years 70 years Both 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 I50 Heart failure Treatment - Drugs Rehabilitation Rehabilitation Control group: Individuals only receive standard medication treatment. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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). Tarbiat Modares University Approved 2021-10-23 Tarbiat Modares University Ethics Committee Tehran Jalal AleAhmad Nasr Tehran Tehran Iran (Islamic Republic of)