comparing the effects of 4 weeks resistance training with intensity of 50%1RM and 75%1RM on quality of life, autonomic function, cardiac function and functional status of patients with heart failure
Design
Three arm parallel group randomized trial with blinded patients, concealed randomization sequence carried out at an external site
Settings and conduct
The eligible patients refer to the hospital after signing informed consent and will be evaluated for quality of life, functional status, autonomic function and cardiac function then allocate to one of the 3 groups randomly and the intervention will done for 4 weeks then at the end of the intervention again will be evaluated for above mentioned variables.
Participants/Inclusion and exclusion criteria
class II, III of stable patients with heart failure, duration of disease:2-4 years, BMI: 25-30kg/m2, optimal medical treatment, ability of communication; pace maker, cardiac surgery during last 6 months, myocardial infarction during last year, personal withdrawal
Intervention groups
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)
Main outcome variables
quality of life, fatigue and dyspnea, Heart rate variability(time and frequency dominants), muscle strength, ejection fraction, cardiac power output, cardiac index, rate pressure product, exercise capacity(metabolic equivalent)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190605043821N1
Registration date:2019-08-06, 1398/05/15
Registration timing:prospective
Last update:2019-08-06, 1398/05/15
Update count:1
Registration date
2019-08-06, 1398/05/15
Registrant information
Name
Marzieh Saeidi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 31 3748 0659
Email address
marziehsaeidi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-07, 1398/05/16
Expected recruitment end date
2020-08-06, 1399/05/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of 4 weeks resistance training with intensity of 50%1RM and 75%1RM on heart rate variability in patients with heart failure
Public title
effects of resistance training on heart rate variability in patients with heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
class II, III of stable heart failure patients
stable and optimal medical treatment
BMI 25-30 kg/m2
Hemoglobin >12(women) and >13(men)
duration of heart failure: 2-4 years
Ejection Fraction: 430-40%
age : 50-70 year
Exclusion criteria:
unstable conditions such as complex ventricular arrhythmia, unstable angina
pace maker
myocardial infarction during last year
cardiac surgery during last 6 months
impairment in which exercise is not safe such as orthopedic ...
cognitive impairments
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization by closed envelops
A person blinded to the research provide 30 envelops for 3 groups (10 envelopes for each group) in a box and then exclude one envelope randomly for each patient without replacement
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyzer has no information about the treatments that subjects had
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
thics committee of Tarbiat Modares University of Medical Sciences
Street address
Jalal ale ahmad highway
City
Tehran
Province
Tehran
Postal code
14115111
Approval date
2019-08-03, 1398/05/12
Ethics committee reference number
IR.MODARES.REC.1398.071
Health conditions studied
1
Description of health condition studied
heart failure
ICD-10 code
I50.2
ICD-10 code description
Systolic (congestive) heart failure
Primary outcomes
1
Description
heart rate variability(time and frequency domain)
Timepoint
before intervention and 4 weeks after beginning intervention
Method of measurement
Qardio-core and ECG Holter monitoring
2
Description
Quality of Life
Timepoint
before intervention and 4 weeks after beginning intervention
Method of measurement
Minnesota Living with Heart Failure(MLHF) Questionnaire
3
Description
Dyspnea
Timepoint
before intervention and 4 weeks after beginning intervention
Method of measurement
Modified Medical Research Council Dyspnea Scale(MRC)
4
Description
Fatigue severity
Timepoint
before intervention and 4 weeks after beginning intervention
Method of measurement
Fatigue Severity Scale (FSS)
5
Description
blood pressure
Timepoint
before intervention and 4 weeks after beginning intervention
Method of measurement
sphygmomanometer
6
Description
heart rate
Timepoint
before intervention and 4 weeks after beginning intervention
Method of measurement
Qardio-core and ECG Holter monitoring
7
Description
muscle strength
Timepoint
before intervention and 4 weeks after beginning intervention
Method of measurement
ِDigital dynamometery
8
Description
Ejection fraction
Timepoint
before intervention and 4 weeks after beginning intervention
Method of measurement
echocardiography
9
Description
cardiac power output
Timepoint
before intervention and 4 weeks after beginning intervention
Method of measurement
CPO=(QT×MAP)×K,CPO: cardiac power output (W) QT: cardiac output (l min−1)MAP: mean arterial pressure (mmHg) K:conversion factor (2.22×10−3)
10
Description
Rate Pressure Product
Timepoint
before intervention and 4 weeks after beginning intervention
Method of measurement
heart rate×systolic blood pressure
11
Description
cardiac index
Timepoint
before intervention and 4 weeks after beginning intervention
before intervention and 4 weeks after beginning intervention
Method of measurement
exercise test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: resistance training with intensity of 50%1RM: patients participate in the exercise program three days a week for four weeks. Each session includes 5 minute warm up, 30 minutes aerobic training with intensity of 50% heart rate reserve, 30 minutes of resistance training(50%1RM) using weights for upper and lower limbs (10 exercise, 2 set of 6-8 repetitions with 1 minute rest between sets and 2 minutes rest between each exercise) and with 5 minutes cool down.
Category
Rehabilitation
2
Description
Intervention group2: resistance training with intensity of 75%1RM: patients participate in the exercise program three days a week for four weeks. Each session includes 5 minute warm up, 30 minutes aerobic training with intensity of 75% heart rate reserve, 30 minutes of resistance training(50%1RM) using weights for upper and lower limbs (10 exercise, 2 set of 6-8 repetitions with 1 minute rest between sets and 2 minutes rest between each exercise) and with 5 minutes cool down.
Category
Rehabilitation
3
Description
Control group: patients participate in the exercise program three days a week for four weeks. Each session includes 5 minute warm up, 30 minutes aerobic training with intensity of 50% heart rate reserve and with 5 minutes cool down.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
ُِShariati hospital
Full name of responsible person
Saeed Reza Mehrpoor
Street address
Jalal al ahmad highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Web page address
http://shariati.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammad Taghi Ahmadi
Street address
Jalal al Ahmad highway
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 2018
Fax
+98 21 8800 6544
Email
pres@modares.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Roya Ravanbod
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4510
Email
ravanbod@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares university
Full name of responsible person
Roya Ravanbod
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4510
Email
ravanbod@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares university
Full name of responsible person
Marzieh Saeidi Kelishadi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 3750
Email
marziehsaeidi@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
There is not any more information
When the data will become available and for how long
There is not any more information
To whom data/document is available
There is not any more information
Under which criteria data/document could be used
There is not any more information
From where data/document is obtainable
There is not any more information
What processes are involved for a request to access data/document