Evaluation of the effect of the cardiac rehabilitation program on dyspnea and the level of indicators of the 6-minute walk test in patients with heart failure
Determining the effect of the cardiac rehabilitation program on the severity of dyspnea and the level of indicators of the 6-minute walk test in patients with heart failure
Design
Randomized controlled clinical trial in which eligible patients are divided into two groups of 37 people, intervention and control.
Settings and conduct
The location of the study was the cardiac special care units of Fatemeh Zahra Hospital in Sari city; Study population: eligible heart failure patients; Type of blinding: no blinding was done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of 18-65 years; definitive diagnosis of heart failure and shortness of breath function class 2 and 3 by a cardiologist; patients with left ventricular ejection fraction less than 40%; having full consent to participate in the study; having normal sinus rhythm before beginning the intervention. Exclusion criteria: having severe and persistent chest pain before the intervention; suffering from to recent myocardial infarction disease (last 6-8 weeks)
Intervention groups
Intervention group: rehabilitation program including a combination of aerobic and resistance exercises in heart failure patients for 12 sessions in one month along with drug treatment. Control group: receives only the usual drug treatment
Main outcome variables
The severity of dyspnea; the level of indicators of the 6-minute walk test (corridor length, blood pressure, heart rate and blood oxygen saturation percentage)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110906007494N44
Registration date:2024-03-14, 1402/12/24
Registration timing:prospective
Last update:2024-03-14, 1402/12/24
Update count:0
Registration date
2024-03-14, 1402/12/24
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-24, 1403/01/05
Expected recruitment end date
2024-06-25, 1403/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of the cardiac rehabilitation program on dyspnea and the level of indicators of the 6-minute walk test in patients with heart failure
Public title
The effect of cardiac rehabilitation on dyspnea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adult age 18 to 65 years
Definitive diagnosis of heart failure and dyspnea function class 2 and 3 by a cardiologist
Patients with left ventricular output fraction less than 40%
Having full consent to participate in the study
Having a normal sinus rhythm before starting the intervention
Exclusion criteria:
Having severe and persistent chest pain before the intervention
Suffering from a recent myocardial infarction (last 6-8 weeks)
Having an arrhythmia that causes any clinical symptoms that prevent exercise before the intervention, such as: severe shortness of breath, cold sweat, dizziness.
Using a wheelchair and having communication problems (hearing, vision and speech impairment)
Suffering from cognitive and mental diseases such as dementia and Alzheimer's
Suffering from neuromuscular and musculoskeletal diseases that cause movement disorders for the patient
Suffering from acute and chronic respiratory infectious diseases such as COPD and cancer
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
The block method will be used to randomly allocate the samples. Patients with heart failure hospitalized in special cardiac care units according to the sample size and inclusion and exclusion criteria were divided into two groups. So that by using random numbers provided by computer software and Permuted Block Randomization by statistical consultant, they are randomly assigned in two groups. Eighteen blocks of size 4 will be used in such a way that 2 people from each group are placed in each block. Therefore, 74 envelopes are designed and based on the information obtained from the computer program, letters A (cardiac rehabilitation group) and letters B (control group) are embedded inside envelopes. Numbers from one to 74 are written on the envelopes. Patients who are admitted to the department and who meet the entry criteria will be included in the study after obtaining written informed consent, and sampling will continue until patient number 74. The envelopes are not transparent and have been waxed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, Moalem street, Moalem square
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2023-09-23, 1402/07/01
Ethics committee reference number
IR.MAZUMS.REC.1402.386
Health conditions studied
1
Description of health condition studied
Dyspnea
ICD-10 code
R06.0
ICD-10 code description
Dyspnea
Primary outcomes
1
Description
The severity of dyspnea
Timepoint
Measuring the severity of dyspnea in the intervention and control groups before the start of the cardiac rehabilitation program and at the end of the 12th session
Method of measurement
modified Medical research council dyspnea scale
2
Description
blood pressure
Timepoint
Measuring the parameters of the walking minute test in the intervention and control groups before the start of the cardiac rehabilitation program and at the end of the 12th session
Method of measurement
Checklist for evaluation of 6-minute walking test indicators
3
Description
Corridor length
Timepoint
Measuring the parameters of the walking minute test in the intervention and control groups before the start of the cardiac rehabilitation program and at the end of the 12th session
Method of measurement
Checklist for evaluation of 6-minute walking test indicators
4
Description
heart rate
Timepoint
Measuring the parameters of the walking minute test in the intervention and control groups before the start of the cardiac rehabilitation program and at the end of the 12th session
Method of measurement
Checklist for evaluation of 6-minute walking test indicators
5
Description
Blood oxygen saturation percentage
Timepoint
Measuring the parameters of the walking minute test in the intervention and control groups before the start of the cardiac rehabilitation program and at the end of the 12th session
Method of measurement
Checklist for evaluation of 6-minute walking test indicators
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The test group is instructed to go to the rehabilitation clinic at Fatemeh Zahra Hospital in Sari after discharge to start the cardiac rehabilitation program. After visiting the clinic and before starting the cardiac rehabilitation program, they will get to know the rehabilitation department, the equipment, the treatment environment and how to perform the exercises, and all the participating patients will be subjected to the initial examination and evaluation program. They will be examined by a sports medicine specialist and a researcher and the information is recorded. All patients who complete the 6-minute test to the end, as well as patients who complete the 6-minute test before the end of the 6-minute period and are unable to continue, will be given time until the end of the 6-minute period and enter the rehabilitation program. Cardiac rehabilitation intervention is performed for one month, 3 sessions a week and for a total of 12 sessions. According to the guidelines of the American College of Sports Medicine (ACSM), each session includes 3 phases of warming up, stimulation phase and cooling down, which according to the age and tolerance of the activity, the warming up and cooling down phases are between 5 and 15 minutes, and 30 minutes of aerobic sports in the stimulation phase. According to the individual's tolerance (according to the Borg criterion or RPE), its intensity increases and decreases in proportion. The Borg scale is a 15-point scale that expresses the level of effort with a scale of 6 to 20, and patients are asked to start walking with an intensity of 13 (almost difficult) and go up to a range of 15 to 16 (heavy and intense) to be maintained during sports activities. Most patients are able to do sports with this intensity range. In this study, the exercises are done alternately on a treadmill, a stationary bike, and a manual ergometer. All patients are subjected to complete cardiopulmonary monitoring during exercise, and at the beginning, the speed of the machine and the incline of the treadmill are lower, and the progress of the patient is checked in each exercise session, and based on the conditions and tolerance of the people and the absence of problems during the next sessions, the duration of time or intensity of exercise increases. If the participants are not able to continue the test for some reasons, they will be excluded from the study. Then, the resistance exercise program based on the guidelines of the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) in the form of 3 sets of 8 to 12 dumbbells, which starts with a light weight of half a kilo in the patient's range of motion, and according to the patient's strength, it increased up to 3 kg during the next sessions. There is a 2 to 3 minute break between aerobic and resistance exercise, and it takes 10 to 15 minutes in total, and at the end, cooling is done.
Category
Rehabilitation
2
Description
Control group: The control group receives only medical treatment related to heart failure at home.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital
Full name of responsible person
Zahra Alizadeh Saravi
Street address
Artesh Boulevard, Fatemeh Zahra Hospital, Sari
City
Sari
Province
Mazandaran
Postal code
4818813371
Phone
+98 11 3332 3024
Email
Zhra.alizadeh.saravi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Moalem Street
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3397 8055
Email
zahra.alizadeh.saravi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Masoume Bagheri Nasami
Position
PhD in nursing education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Research Center of Mazandaran University of Medical Sciences; Khazar Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3324 4893
Email
mbagheri@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Masoume Bagheri Nasami
Position
PhD in nursing education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences, Jouibar three-way; Bassij Highway; Imam Square
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7551
Email
Anna3043@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
PhD in nursing education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences, Jouibar three-way; Bassij Highway; Imam Square
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7551
Email
Anna3043@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD