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
Design
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.
Settings and conduct
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.
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 available sampling method.
Intervention groups
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.
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 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
Exclusion criteria:
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
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:
24
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, 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 Persia 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
Basic respiration rate
Timepoint
One month before the intervention, 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 Persia respirometer
2
Description
Inflammation
Timepoint
One month before the intervention, 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 enzyme-linked immunosorbent assay
3
Description
heart rate variability
Timepoint
One month before the intervention, 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
One month before the intervention, 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
One month before the intervention, 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
3
Description
Triglyceride
Timepoint
One month before the intervention, 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
4
Description
high-density lipoprotein (HDL)
Timepoint
One month before the intervention, 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
5
Description
low-density lipoprotein (LDL)
Timepoint
One month before the intervention, 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
6
Description
Systolic blood pressure at rest
Timepoint
One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
According to average Holter blood pressure report
7
Description
Diastolic blood pressure at rest
Timepoint
One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
According to average Holter blood pressure report
8
Description
Rate of perceived exertion
Timepoint
One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
Based on the Borg scale
9
Description
standard deviation of NN intervals (SDNN)
Timepoint
One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
According to the report of cardiac Holter device
10
Description
root mean square of successive differences between normal heartbeats (RMSSD)
Timepoint
One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
According to the report of cardiac Holter device
11
Description
The percentage of adjacent NN intervals that differ from each other by more than 50 ms (pNN50)
Timepoint
One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
According to the report of cardiac Holter device
12
Description
Functional capacity
Timepoint
One month before the intervention, 48 hours before the intervention and 48 hours after the end of four weeks of intervention
Method of measurement
Based on a 6-minute walk test
Intervention groups
1
Description
Control group: It is parallel. Each sample has its own control one month before the intervention.
Category
N/A
2
Description
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.
Category
Rehabilitation
3
Description
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.
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
mahmadi@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?