Protocol summary

Summary
This study is a randomized controlled trial that will evaluate the effects of cardiac rehabilitation in patients with congestive heart failure. Fifty ambulatory patients with CHF diagnosed and followed by the Cardiologist will be recruited to the study. Inclusion criteria: patient with NYHA classification 2 or 3 with ejection fraction less than 45 and older than 50 years old who is referred by cardiologist for cardiac rehabilitation. Exclusion criteria: diabetes mellitus; obstructive cardiomyopathy; arrhythmia; uncontrolled HTN(systolic blood pressure more than 200 and diastolic blood pressure more than 120); aortic stenosis; recent myocardial infarction; symptomatic pectoralis angina; patient with muscular or skeletal deformity that is limited physical activity and cardiac surgery. Patients will be randomized by using the sequence of random numbers either to case and control groups. All patients continue their recommended medication and diet during the study. The control groups continue their medication and are encouraged to perform their routine daily activities, whereas the exercise group participates in cardiac rehabilitation program in addition to their usual medication. The control group performs cardiac rehabilitation three times a week for 40 sessions. Each session begin with 10 minutes warm up and stretching exercise and proceeded with interval training method: 20 seconds with 50% maximal resistance and 40 seconds with 20% of maximal resistance (maximal resistance is measured with ramp test). This method continues up to 20 minutes and end with 10 minutes cool down and stretching exercise. Total duration of exercise is 30 minutes arm ergometry and 30 minutes leg ergometry. In this randomized controlled trial, ejection fraction and quality of life of all patients will be assessed at the beginning and at the end of the study (4 months later).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014040517126N1
Registration date: 2014-06-12, 1393/03/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-06-12, 1393/03/22
Registrant information
Name
Narges Mohassel
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1229 6620
Email address
mohasel_n@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2014-04-09, 1393/01/20
Expected recruitment end date
2014-04-30, 1393/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of cardiac rehabilitation in patients with conjestive heart failure
Public title
Effects of cardiac rehabilitation in patients with heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient with NYHA classification 2 or 3 with ejection fraction less than 45 and older than 50 years old who is referred by cardiologist for cardiac rehabilitation. Exclusion criteria: diabetes mellitus; obstructive cardiomyopathy; arrhythmia; uncontrolled HTN(systolic blood pressure more than 200 and diastolic blood pressure more than 120); aortic stenosis; recent myocardial infarction; symptomatic pectoralis angina; patient with muscular or skeletal deformity that is limited physical activity and cardiac surgery.
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
shiraz university of medical science
Street address
zand street.shiraz university of medical science
City
shiraz
Postal code
Approval date
2014-03-09, 1392/12/18
Ethics committee reference number
CT-P092-4584

Health conditions studied

1

Description of health condition studied
Conjestive heart failure
ICD-10 code
I50.0
ICD-10 code description
Congestive heart failure

Primary outcomes

1

Description
Ejection fraction
Timepoint
Before intervention, one month after intervention
Method of measurement
Echocardiography

2

Description
Quality of life
Timepoint
Before intervention, one month after intervention
Method of measurement
SF 36 quality of life quastionnaire

Secondary outcomes

empty

Intervention groups

1

Description
the patients perform cardiac rehabilitation three times a week for 40 sessions.each session begin with 10 minutes warm up and streching exercise and procede with interval training method :20 seconds with 50% maximal resistance and 40 seconds with 20% of maximal resistance(maximal resistance is measured with ramp test).this method continue up to 20 minutes and end with 10 minutes cool down and streching exercise.total duration of exercise is 30 minutes arm ergometry and 30 minutes leg ergometry.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Faghihi hospital
Full name of responsible person
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Physical Medicine and Rehabilitation ward, Shiraz University of Medical Sciencs
Full name of responsible person
Kaynush Homayouni
Street address
Shiraz University of Medical Sciences , Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Medicine and Rehabilitation ward, Shiraz University of Medical Sciencs
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Narges Mohassel
Position
Physical medicine and rehabilitation resident
Other areas of specialty/work
Street address
Faghihi hospital
City
Shiraz
Postal code
Phone
+98 71 1229 6620
Fax
Email
mohasel_n@gmail.com; nargesmohassel@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Kaynush Homayouni
Position
Assistant professor
Other areas of specialty/work
Street address
Faghihi hospital
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
kayhomayouni@yahoo.com nargesmohassel@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Narges Mohassel
Position
Physical medicine and rehabilitation resident
Other areas of specialty/work
Street address
Faghihi hospital
City
Shiraz
Postal code
Phone
+98 71 1229 6620
Fax
Email
mohasel_n@sums.ac.ir; nargesmohassel@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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