The aim of this study is to evaluate educational exercise intervention efficiency based on social cognitive theory in patients empowerment diagnosed with heart failure.This study is parallel groups randomized clinical trial with pre/post design. All patients are recruited among patients diagnosed with cardiovascular disease who are referred to the cardiac rehabilitation in Isfahan Cardiovascular Research Center by a cardiologist. Of them 60 patients who meet the inclusion criteria ( for example: EF less than 40% and NYHA Class II and Class III ) recruited in the study. Participants are randomised to either intervention or control group through block randomisation using permuted blocks random numbers after baseline questionnaires and assessment are completed. At first, all patients are obtained informed consent form. Patients participate in cardiac rehabilitation program in both groups thrice for a week of eight weeks. For people in the intervention group, the research person also holds the weekly social cognitive theory-based educational sessions and face to face intervention during rehabilitation program. Content education covers self-management components, warning sign for heart failure, understanding risk for heart failure, what exercise you can do and how can you get your heart rate. Patient are ask to take walking, jogging, biking,calisthenics every week . The families are educated about their supportive role in patient exercise. Post rehabilitation assessment is done.Out come measures are conducted at one, three and six months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012113011616N1
Registration date:2013-01-03, 1391/10/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-03, 1391/10/14
Registrant information
Name
Fatemeh Rajati
Name of organization / entity
Isfahan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2652
Email address
f_rajati@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Science
Expected recruitment start date
2012-03-08, 1390/12/18
Expected recruitment end date
2013-03-08, 1391/12/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Surrvey of educational exercise intervention efficiency based on social cognitive theory in patients empowerment diagnosed with heart failure
Public title
Effect of educational exercise intervention on heart failure
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
(a) age 21 years or greater.
(b) optimum medical therapy with no changes in medications within the past 30 days.
(c) New York Heart Association (NYHA) Class II and Class III.
(d) resting left ventricular ejection fraction < 40%.
(e)able to speak and read Persian.
(f)Willingness to participate in the study.
Exclucion criteria:
(a) clinical evidence of decompensated HF.
(b) unstable angina pectoris.
(c) orthopedic or neuromuscular disorders preventing participation in exercise and strength/resistance training.
Age
From 30 years old to 69 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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 Isfahan University of Medical Sciences
Street address
Medical university of Isfahan, Hezar jarib St. Isfahan, Iran
City
Isfahan
Postal code
8174673461
Approval date
2012-03-05, 1390/12/15
Ethics committee reference number
391016
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Physical activity
Timepoint
Befor, after, one month, three months after intervention
The Patient Knowledge Questionnaire for Heart Failure Patients
Intervention groups
1
Description
Control group: Rehabilitation program for 8-week course of exercise (three 60-minute sessions per week). Frequency of steady state training is included 5-10 minutes sessions 3 times per week for more compromised patients; 20–30 minutes sessions 3 times per week for patients with good functionalcapacity. Intensity of training sessionsis included initial phase that it is 40–50% peak VO2, increasing duration from 5–15 minutes and inimprovement phase that it is gradual increase to 60–80% peak VO2, increasing duration to 15–20 minutes (up to 30 minutes as secondary goal). Patient work out in interval training by cycling and treadmill. Patiets exercise in work phase of 30–120 seconds and recovery phase of 60–120 seconds at an intensity of 50% of maximum short term capacity (determined on exercise bike) by cycling. Heart failure patients work out with tredmill in work and recovery phases 60 seconds each. The cardiac rehabilitation is also included combination of nutritional counseling, medication follow-ups, stress management and depression counseling.
Category
Rehabilitation
2
Description
Intervention group: the intervention group are attended the weekly social cognitive theory-based educational sessions and face to face intervention during rehabilitation program. Content education covers self-management components, warning sign for heart failure, understanding risk for heart failure, what exercise you can do and how can you get your heart rate. Patient are encouraged to take walking, jogging, biking,calisthenics on nonrehabilitation days, because some patients who develop exhaustion after training may need a day of rest between sessions, these recommendation are offerd by the specialist in sport medicine. The families are educated about their supportive role in patient exercise. Pamphlet, book, CD and other material about heart failure and exercise are provided for patients.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Cardiovascular Research Center
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr MOhammad Mahdi Amin
Street address
Isfahan, Hezar Jarib Str, Isfahan University of Medical Science
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Fatemeh Rajati
Position
phD candidate
Other areas of specialty/work
Street address
Department Of Health Education and Promotion, Isfahan University of Medical Science, Hezar Jarib Str
City
Isfahan
Postal code
Phone
+98 31 1792 2652
Fax
Email
f_rajati@hlth.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Firoozeh Mostafavi
Position
PhD in communityHealth
Other areas of specialty/work
Street address
Department of Health Education and Promotion, School of Public, Isfahan University of Medical Science, Hezar Jarib Str
City
Isfahan
Postal code
Phone
+98 31 1792 2671
Fax
Email
mostafavi@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fatemeh Rajati
Position
PhD candidate
Other areas of specialty/work
Street address
Department of Health Education and Promotion, Isfahan University of Medical Science
City
Isfahan
Postal code
Phone
+98 31 1792 2652
Fax
Email
f_rajati@hlth.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)