Protocol summary

Summary
This study is a randomized clinical trial which was performed in Sayyed-o-shohada and Talegani Hospitals,affiliated to Urmia University of Medical Sciences in 2011. The purpose of this study was to assess the impact of cardiac rehabilitation (CR) and progressive muscle relaxation (PMR) on the quality of life (QOL) in patients with cardiac syndrome X. For this purpose,40 eligible and consenting women (age 30-65) with cardiac syndrome X were randomly assigned to 4 groups. In the first group (n=11), progressive muscle relaxation, based on Jacobson's method, performed for 15min /day for 8 weeks; in the second group (n=11), phase III CR performed three times/week for 8 weeks, and in the third group (n=11), progressive muscle relaxation along with phase III CR performed for 8 weeks at home. The fourth group (n=7) was used as control group. Before study and after the 8-week periods, data were gathered through short form of QOL questionnaire (SF-36), hospital anxiety and depression scale, short form of international physical activity questionnaire and chest pain check list.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201204099422N1
Registration date: 2012-06-10, 1391/03/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-06-10, 1391/03/21
Registrant information
Name
Aram Feizi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1336 5836
Email address
aramfeizi@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2011-10-17, 1390/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cardiac rehabilitation and relaxation on the quality of life in patients with cardiac syndrome x in hospitals affiliated to Urmia University of Medical Sciences .
Public title
Effect of cardiac rehabilitation and relaxation on the quality of life in patients with cardiac syndrome X
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 30-65 year old; Women; Urmia resident; Willing to give written informed consent; Confirmed by a cardiologist to participate in exercise programs. Exclusion criteria: History of psychiatric illness; History of any other chronic illness; Presence of any physical condition for which exercise is contraindicated; Participation in moderate intensity exercise programsat least 2 times per week during the past 6 months; Participation in relaxation or meditation programs during the past 6 months
Age
From 30 years old to 65 years old
Gender
Female
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
Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat Boulevard
City
Urmia
Postal code
Approval date
2012-05-26, 1391/03/06
Ethics committee reference number
پ/4/502

Health conditions studied

1

Description of health condition studied
Cardiac syndrome x
ICD-10 code
I25.9
ICD-10 code description
Chronic ischaemic heart disease, unspecified

Primary outcomes

1

Description
Quality of life
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Short form of QOL questionnaire (SF-36)

Secondary outcomes

1

Description
Anxiety and Depression
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Hospital anxiety and depression scale

2

Description
Physical activity
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Short form of international physical activity questionnaire

3

Description
Chest pain
Timepoint
After intervention
Method of measurement
Daily chest pain check list

Intervention groups

1

Description
CR group: 8-week participation in phase III cardiac rehabilitation exercise program at home,3 times per week with 60-65% of maximum heart rate + Current treatment
Category
Lifestyle

2

Description
CR & PMR group: 8-week participation in phase III cardiac rehabilitation exercise program at home,3 times per week with 60-65% of maximum heart rate + 8-week participation in progressive muscle relaxation program based on Jacobson's method, 15 minutes daily at home + Current treatment
Category
Lifestyle

3

Description
PMR group: 8-week participation in progressive muscle relaxation program based on Jacobson's method, 15 minutes daily at home + Current treatment.
Category
Lifestyle

4

Description
Control group: Current treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr. Mohammad Reza Dehghani
Street address
Taleghani Hospital, Kashani Street, Urmia
City
Urmia

2

Recruitment center
Name of recruitment center
Seyyed-o-alshohada Hospital
Full name of responsible person
Dr. Mohammad Reza Dehghani
Street address
Seyyed-o-alshohada Hospital, 17 Shahrivar Street, Urmia
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. Morteza Motazaker
Street address
Urmia University of Medical Sciences
City
Urmia
Grant name
ردیف پژوهشی معاونت تحقیقات و فناوری
Grant code / Reference number
10506000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Dr. Aram Feizi
Position
PhD of Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Urmia University of Medical Sciences
City
Urmia
Postal code
Phone
+98 44 1275 2917
Fax
Email
aramfeizi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. Aram Feizi
Position
PhD of Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Urmia University of Medical Sciences
City
Urmia
Postal code
Phone
+98 44 1275 2917
Fax
Email
aramfeizi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing and Midwifery Faculty
Full name of responsible person
Chiman Ghaderi
Position
MSc Student of Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Urmia University of Medical Sciences
City
Urmia
Postal code
Phone
+98 44 1275 2916
Fax
Email
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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