Protocol summary
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Study aim
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comparing the acute effects of resistance exercise with the intensity of 50%1RM and 75%1RM on autonomic function, cardiac function and functional status of patients with heart failure
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Design
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Three-arm parallel-group randomized-controlled trial with blinded patients, concealed randomization sequence
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Settings and conduct
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Due to the fact that the Persian form of the subjective exercise experience scale is not available, the validity and reliability of this scale were examined among a healthy matched control population of 128 volunteer adults who will request to walk for 30 minutes after consent. The eligible patients refer to the hospital after signing informed consent and will be evaluated for autonomic function, cardiac function, functional status, and their psychological response to exercise, then allocate to one of the 3 groups randomly. The intervention consists of a single session resistance exercise and at the end of the intervention again will be evaluated for the above-mentioned variables.
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Participants/Inclusion and exclusion criteria
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class II, III of stable patients with heart failure, duration of disease:1-4 years, BMI: 25-32kg/m2, optimal medical treatment, the ability of communication; pacemaker, cardiac surgery during last 6 months, myocardial infarction during last year, personal withdrawal
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Intervention groups
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1-resistance training with intensity of 50%1RM + aerobic training
2--resistance training with intensity of 75%1RM+ aerobic training
3-control group(aerobic training)
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Main outcome variables
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Heart rate variability(time and frequency dominants), hemodynamics (heart rate, blood pressure, rate pressure product), subjective exercise experiences scale, six minute walking test distance
General information
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Reason for update
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We have to change the project to some extent because of the Coronavirus and stoping the project due to the traffic ban for high-risk patients like heart failure.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190605043821N1
Registration date:
2019-08-06, 1398/05/15
Registration timing:
prospective
Last update:
2021-01-04, 1399/10/15
Update count:
1
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Registration date
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2019-08-06, 1398/05/15
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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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2019-08-07, 1398/05/16
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Expected recruitment end date
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2021-03-06, 1399/12/16
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the acute effects of resistance exercise with intensity of 50%1RM and 75%1RM on heart rate variability in patients with heart failure
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Public title
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effects of resistance training on 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, III of stable heart failure patients
stable and optimal medical treatment
BMI 25-35 kg/m2
Hemoglobin >12(women) and >13(men)
duration of heart failure: 1-4 years
Ejection Fraction: <40%
age : 45-75 year
Exclusion criteria:
unstable conditions such as complex ventricular arrhythmia, unstable angina
pacemaker
myocardial infarction during last year
cardiac surgery during last 6 months
impairment in which exercise is not safe such as orthopedic ...
cognitive impairments
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Age
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From 45 years old to 75 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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Sample size
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Target sample size:
19
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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simple randomization by closed envelops
A person blinded to the research provide 57 envelops for 3 groups (19 envelopes for each group) in a box and then exclude one envelope randomly for each patient without replacement
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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 data analyzer is not aware of the treatment performed for individuals
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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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Ethics committees
1
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Ethics committee
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Approval date
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2019-08-03, 1398/05/12
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Ethics committee reference number
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IR.MODARES.REC.1398.071
Health conditions studied
1
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Description of health condition studied
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heart failure
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ICD-10 code
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I50.2
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ICD-10 code description
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Systolic (congestive) heart failure
Primary outcomes
1
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Description
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heart rate variability(time and frequency domain)
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Timepoint
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before and immediately after the intervention
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Method of measurement
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ECG Holter monitoring
2
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Description
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Quality of Life
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Timepoint
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before the intervention
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Method of measurement
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Minnesota Living with Heart Failure(MLHF) Questionnaire
3
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Description
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Dyspnea
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Timepoint
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before the intervention
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Method of measurement
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Modified Medical Research Council Dyspnea Scale(MRC)
4
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Description
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Fatigue severity
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Timepoint
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before the intervention
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Method of measurement
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Fatigue Severity Scale (FSS)
5
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Description
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blood pressure
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Timepoint
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before and immediately after the intervention
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Method of measurement
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sphygmomanometer
6
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Description
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heart rate
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Timepoint
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before and immediately after the intervention
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Method of measurement
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Qardio-core and ECG Holter monitoring
7
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Description
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muscle strength
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Timepoint
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before and immediately after the intervention
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Method of measurement
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ِDigital dynamometery
8
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Description
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Rate Pressure Product
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Timepoint
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before and immediately after the intervention
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Method of measurement
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heart rate×systolic blood pressure
9
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Description
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psychological response to the exercise stimulus
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Timepoint
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before and immediately after the intervention
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Method of measurement
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subjective exercise experience scale (SEES)
Intervention groups
1
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Description
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Intervention group1: resistance exercise with the intensity of 50%1RM: a single exercise session includes 5 minutes warm-up, 15 minutes of aerobic exercise with the intensity of 50% heart rate reserve, 30 minutes of resistance training (50%1RM) using weights for upper and lower limbs (10 exercises, 2 sets of 6-8 repetitions with 1-minute rest between sets and exercises), and 5 minutes cool down
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Category
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Rehabilitation
2
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Description
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Intervention group2: resistance exercise with the intensity of 75%1RM: a single exercise session includes 5-minutes warm-up, 15 minutes of aerobic exercise with the intensity of 50% heart rate reserve, 30 minutes of resistance exercise (75%1RM) using weights for upper and lower limbs (10 exercises, 2 sets of 6-8 repetitions with 1-minute rest between sets and exercises), and 5 minutes cool down
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Category
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Rehabilitation
3
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Description
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Control group: a single session exercise includes 5 minutes warm up, 15 minutes aerobic exercise with intensity of 50% heart rate reserve, and 5 minutes cool down
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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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Undecided - It is not yet known if there will be 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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Yes - There is 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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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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There is not any more information
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When the data will become available and for how long
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There is not any more information
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To whom data/document is available
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There is not any more information
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Under which criteria data/document could be used
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There is not any more information
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From where data/document is obtainable
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There is not any more information
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What processes are involved for a request to access data/document
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There is not any more information
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Comments
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There is not any more information