The aim of this study is to determine the effects of cardiac rehabilitation on the quality of life, functional capacity and maximal exercise capacity in patients with recurrence of symptoms after coronary stenting. Fifty patients who had inclusion criteria, were included randomly in the two groups: intervention (25 people) and control (25 people) after obtaining the informed written consent.Inclusion criteria: recurrence of symptoms( chest pain or dyspnea ) after primary coronary stenting.Exclusion criteria:
history of coronary artery bypass graft surgery (CABG); functional class 4 according to New York Heart Association(NYHA); severe valvular heart disease; uncontrolled hypertension; uncontrolled diabetes mellitus or thyroid disease; recent myocardial infarction or unstable angina pectoris.The control group continues their routine medications and daily activities, whereas the intervention group participates in cardiac rehabilitation program in addition to continuing their routine medications.
Cardiac rehabilitation program continues three times a week for twenty sessions. Each session begins with 5 minutes warm up and stretching exercises and proceeds with intermittent interval training method: 20 seconds with 50% maximal resistance and 40 seconds with 20% of maximal resistance (maximal resistance is measured by ramp test). This method continues up to 20 minutes and ends with 5 minutes cool down and stretching exercises.Total duration of each session is 1 hour(30 minutes for arm exercise and 30 minutes for leg exercise). We will determine the quality of life of all patients, their functional capacity and maximal exercise capacity by the quality of life SF-36 questionnaire, 6 minute walk test(6MWT) and ramp test respectively, in both intervention and control groups at the beginning and end of the study(2 months later).Then the results are compared statistically between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042421921N1
Registration date:2015-06-01, 1394/03/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-01, 1394/03/11
Registrant information
Name
Fateme Roshanaei Haydarabadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
roshanaei@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-03-25, 1394/01/05
Expected recruitment end date
2015-05-26, 1394/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effects of cardiac rehabilitation in patients with recurrence of symptoms after percutaneous coronary intervention (coronary stenting)
Public title
The effects of cardiac rehabilitation in patients with chest pain after coronary stenting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The age of forty to seventy years; patients with coronary artery disease that coronary stenting was done for them; recurrence of symptoms (angina or dyspnea) at any time after coronary stenting; ejection fraction: 35% or more; primary stenting.
Exclusion criteria: history of coronary artery bypass graft surgery (CABG); functional class 4 according the New York Heart Association(NYHA); severe valvular heart disease; arrhythmia except atrial fibrillation (without rapid ventricular response); uncontrolled hypertension(systolic blood pressure more than 200 mmHg or diastolic blood pressure more than 120 mmHg); uncontrolled diabetes mellitus or thyroid disease; recent myocardial infarction or unstable angina pectoris; exercise limitation due to neuromuscular, musculoskeletal or mental diseases
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
The Ethics Committe of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Postal code
Approval date
2015-03-01, 1393/12/10
Ethics committee reference number
CT-P-9387-8097
Health conditions studied
1
Description of health condition studied
Recurrence of symptoms after percutaneous coronary intervention
ICD-10 code
Z95.5
ICD-10 code description
presence of coronary angioplasty implant and graft
Primary outcomes
1
Description
functional capacity
Timepoint
at the beginning of the study and after 2 months
Method of measurement
distance walked on the 6 min walk test( in meters )
2
Description
maximal exrcise capacity
Timepoint
at the beginning of the study and after 2 months
Method of measurement
maximum workload tolerated by the patient on the ramp test(in watts)
Secondary outcomes
1
Description
quality of life
Timepoint
at the beginning of the study and after 2 months
Method of measurement
Quality of Life SF-36 questionnaire
Intervention groups
1
Description
The intervention group receives cardiac rehabilitation three times a week for twenty sessions.Each session begins with 5 minutes warm up and stretching exercises and proceeds with intermittent interval training method: 20 seconds with 50% maximal resistance and 40 seconds with 20% of maximal resistance (maximal resistance is measured by ramp test). This method continues up to 20 minutes and ends with 5 minutes cool down and stretching exercises.Total duration of each session is 1 hour(30 minutes for arm exercise and 30 minutes for leg exercise).
Category
Rehabilitation
2
Description
The control group receives no intervention and continues their routine medications and daily activities without any change.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiac Rehabilitation Center of Shahid Faghihi Hospital
Full name of responsible person
Fateme Roshanaei
Street address
Shahid Faghihi Hospital, Zand Avenue, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Roshanaei
Position
physical medicine and rehabilitation resident
Other areas of specialty/work
Street address
Shahid Faghihi Hospital, Zand Avenue
City
Shiraz
Postal code
Phone
+98 71 3627 7156
Fax
Email
roshanaei@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
kaynoosh Homayouni
Position
assistant professor of physical medicine and rehabilitation
Other areas of specialty/work
Street address
Shahid Faghihi Hospital, Zand Avenue
City
Shiraz
Postal code
Phone
+98 71 3231 9040
Fax
Email
khomayouni@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Roshanaei
Position
physical medicine and rehabilitation resident
Other areas of specialty/work
Street address
Shahid Faghihi Hospital, Zand Avenue
City
Shiraz
Postal code
Phone
Fax
Email
roshanaei@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)