Protocol summary
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Study aim
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Comparison of Routine Respiratory and Gradual Device-guided Slow Breathing Exercises on Inflammation and Heart Rate Variability in Patients With Heart Failure
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Basic respiration rate; Inflammation; Heart Rate Variability
General information
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Reason for update
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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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Acronym
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IRCT registration information
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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
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Registration date
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2021-12-04, 1400/09/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-12-11, 1400/09/20
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Expected recruitment end date
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2023-04-20, 1402/01/31
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Actual recruitment start date
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2022-01-08, 1400/10/18
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Actual recruitment end date
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2023-02-13, 1401/11/24
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Trial completion date
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2023-03-13, 1401/12/22
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Scientific title
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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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Public title
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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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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 50 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
36
Actual sample size reached:
36
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Individuals are randomly assigned to one of the groups by a researcher using a Concealed envelope method.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Design and construction of a respirometer biofeedback device for respiratory training of the subjects
Ethics committees
1
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Ethics committee
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Approval date
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2021-10-23, 1400/08/01
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Ethics committee reference number
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IR.MODARES.REC.1400.200
Health conditions studied
1
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Description of health condition studied
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Chronic heart Failure
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ICD-10 code
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I50
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ICD-10 code description
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Heart failure
Primary outcomes
1
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Description
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The basic rate of respiration
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Timepoint
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48 hours before the intervention and 48 hours after the end of four weeks of intervention
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Method of measurement
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Average rate of five minutes of respiration based on respirometer biofeedback.
2
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Description
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Inflammation
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Timepoint
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48 hours before the intervention and 48 hours after the end of four weeks of intervention
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Method of measurement
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According to the report of TNF-alpha in an enzyme-linked immunosorbent assay device
3
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Description
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Heart Rate Variability
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Timepoint
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48 hours before the intervention and 48 hours after the end of four weeks of intervention
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Method of measurement
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Holter monitoring device
Secondary outcomes
1
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Description
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Quality of Life
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Timepoint
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48 hours before the intervention and 48 hours after the end of four weeks of intervention
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Method of measurement
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Minnesota Quality of Life Questionnaire Score
2
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Description
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Cholesterol
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Timepoint
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48 hours before the intervention and 48 hours after the end of four weeks of intervention
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Method of measurement
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Based on an autoanalyzer device's report from a person's blood serum
3
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Description
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Triglyceride
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Timepoint
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48 hours before the intervention and 48 hours after the end of four weeks of intervention
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Method of measurement
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From a person's blood serum based on the report of an autoanalyzer device
4
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Description
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High-Density Lipoprotein (HDL)
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Timepoint
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48 hours before the intervention and 48 hours after the end of four weeks of intervention
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Method of measurement
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From a person's blood serum based on the report of an autoanalyzer device
5
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Description
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Low-Density Lipoprotein (LDL)
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Timepoint
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48 hours before the intervention and 48 hours after the end of four weeks of intervention
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Method of measurement
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From a person's blood serum based on the report of an autoanalyzer device
6
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Description
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Systolic blood pressure at rest
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Timepoint
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48 hours before the intervention and 48 hours after the end of four weeks of intervention
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Method of measurement
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According to the average Holter blood pressure report
7
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Description
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Diastolic blood pressure at rest
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Timepoint
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48 hours before the intervention and 48 hours after the end of four weeks of intervention
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Method of measurement
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According to the average Holter blood pressure report
8
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Description
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Rate of perceived exertion
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Timepoint
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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
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Method of measurement
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Based on the Borg scale
9
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Description
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Standard Deviation of NN Intervals (SDNN)
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Timepoint
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48 hours before the intervention and 48 hours after the end of four weeks of intervention
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Method of measurement
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According to the report of the cardiac Holter device
10
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Description
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Root Mean Square of Successive Differences between normal heartbeats (RMSSD)
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Timepoint
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48 hours before the intervention and 48 hours after the end of four weeks of intervention
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Method of measurement
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According to the report of the cardiac Holter device
11
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Description
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The Percentage of adjacent NN intervals that differ from each other by more than 50 ms (pNN50)
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Timepoint
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48 hours before the intervention and 48 hours after the end of four weeks of intervention
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Method of measurement
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According to the report of the cardiac Holter device
12
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Description
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Physical Functional Performance
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Timepoint
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48 hours before the intervention and 48 hours after the end of four weeks of intervention
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Method of measurement
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Based on the 6-Minute Walk Test (6MWT)
Intervention groups
1
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Description
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Control group: Individuals only receive standard medication treatment.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Rehabilitation
3
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tarbiat Modares University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Part of the data
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When the data will become available and for how long
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8 months after publication
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To whom data/document is available
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researchers
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Under which criteria data/document could be used
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For medical and research purposes
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From where data/document is obtainable
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Roya Ravanbod
Tarbiat Modares University
ravanbod@modares.ac.ir
https://www.modares.ac.ir/pro/academic_staff/ravanbod
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What processes are involved for a request to access data/document
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Approval of supervisors
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Comments
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