The effect of exercise-based cardiac rehabilitation after Percutaneous Coronary Interventions (PCIs) on functional capacity and fatigue in patients with coronary heart disease
The purpose of this clinical trial is evaluation of the effect of exercise-based cardiac rehabilitation after Percutaneous Coronary Interventions (PCIs) on functional capacity and fatigue in patients with coronary heart disease. Among the study population of patients with coronary heart disease after angioplasty or stenting and referred to cardiac rehabilitation center, 40 patients 35 to 65 years that they have at least three weeks of treatment in the study are. All the patients after the introduction the study and signing written consent, two demographic questionnaire and multidimensional fatigue index (MFI) questionnaire has been completed and 6-minute walk test will be done for them. These patients will be randomized into two groups (20 patients) and control group (20 patients). Patients in the intervention group underwent 24 sessions of cardiac rehabilitation, 3 per week for 8 weeks fall. Each session uses two treadmills and bicycle rehabilitation carried out the 10-15 minute warm-up in the first and 10-15 minutes cool down in the end done and each session lasts approximately one hour. At the end of the session of 12 and 24, fatigue questionnaire completed and 6-minute walk test was done and the end results are analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102924784N1
Registration date:2016-02-05, 1394/11/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-05, 1394/11/16
Registrant information
Name
Mahsa Khoram Kish
Name of organization / entity
Yasuj Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5141
Email address
khoramkish.mahsa@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology, Yasuj University of Medical Science
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercise-based cardiac rehabilitation after Percutaneous Coronary Interventions (PCIs) on functional capacity and fatigue in patients with coronary heart disease
Public title
the effect of cardiac rehabilitation on functional capacity and fatigue
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age range 65-35 years; do any of the percutaneous coronary intervention (angioplasty and stent insertion) and at least 3 weeks after; the written permission of cardiologist not to ban rehabilitation; ejection fraction greater than or equal (35%); lack of mental disorders; chronic and debilitating respiratory disease and musculo-skeletal disorders; informed consent. Exclusion criteria: patient's lack of motivation to continue working; inability to perform rehabilitation (exercise); absence of more than 3 session of rehabilitation exercises; exacerbation's during the rehabilitation; migration; disease and death.
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Yasuj Univercity of Medical Sciences
Street address
Yasuj Univercity of Medical Sciences, Shahid Motahhari Blvd.
City
Yasuj
Postal code
7591741417
Approval date
2015-11-24, 1394/09/03
Ethics committee reference number
IR.YUMS.REC.1394.102
Health conditions studied
1
Description of health condition studied
Coronary heart disease
ICD-10 code
I25.9
ICD-10 code description
Chronic ischaemic heart disease, unspecified
Primary outcomes
1
Description
Functional capasity
Timepoint
Before intervention, after 12th session, after 24th session
Method of measurement
6 Minute Walk Test (6MWT)
2
Description
Fatigue
Timepoint
Before intervention, after 12th session, after 24th session
Method of measurement
Multidimensional Fatigue Index (MFI) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the control group: non-implementation of cardiac rehabilitation and reliance on routine management
Category
N/A
2
Description
In the intervention group: 24 session of exercise-base cardiac rehabilitation (3 per week) for an hour each session by using a treadmill and bicycle
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Jahrom Cardiac Rehabilitation Center
Full name of responsible person
Street address
Peymaniyeh hospital, Valiasr St.
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, Yasuj University of Medical Sciences
Full name of responsible person
Dr. Mehdi Akbartabar Tori
Street address
Yasuj University of Medical Sciences, Shahid Motahhari blvd.
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Yasuj 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
Yasuj University of Medical Sciences
Full name of responsible person
Ardashir Afrasiabifar
Position
PhD
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Faculty of Nursing and Midwifery, Shahid Dr. Jalil St.
City
Yasuj
Postal code
75919 94779
Phone
+98 74 3323 5141
Fax
+98 74 1223 4115
Email
afrasiabifar@yahoo.com
Web page address
www.yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Ardashir Afrasiabifar
Position
PhD
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Faculty of Nursing and Midwifery, Shahid Dr. Jalil St.
City
Yasuj
Postal code
7591741417
Phone
+98 74 3323 5141
Fax
+98 74 1333 7370
Email
afrasiabifar@yahoo.com
Web page address
www.yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Mahsa Khoram Kish
Position
Master student of nursing
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Faculty of Nursing and Midwifery, Shahid Dr. Jalil St.
City
Yasuj
Postal code
Phone
+98 71 5427 5090
Fax
Email
khoramkish68@gmail.com
Web page address
www.yums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)