Background and aim: The overall goal of this study is to evaluate the effectiveness of a physical activity prescription on type 2 diabetic patients’ quality of life.
Material & methods: consenting eligible type 2 diabetic patients referred to endocrine research clinic of Iran University of Medicine will be enrolled in the study by convenience method. They then will be randomly allocated in two 40 person groups (block randomization) receiving either routine education about life style modification or the physical activity prescription plus the routine education. The WHO quality of life questionnaire will be completed by each participant at the beginning of the study and then 3 months after the enrollment. Patients in the prescription group will receive set tables of physical activity which they will bring to each visit. The physical activity questionnaire IPAQ (long form) will be completed for each participant at first, 1.5 and 3months visits. The results will be analyzed and compared between the 2 groups and if effective the physical activity prescription will be included in the routine type 2 diabetic patients’ care.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082029372N4
Registration date:2016-08-24, 1395/06/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-24, 1395/06/03
Registrant information
Name
Marzieh Molavi Nojomi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8860 2225
Email address
mnojomi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research & Technology Iran University of Medical Sciences
Expected recruitment start date
2016-09-05, 1395/06/15
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of prescription of physical activity on quality of life of patients with diabetes
Public title
The effectiveness of physical activity on quality of life of patients with diabetes type 2
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : The men≤45 years and women ≤55 years; patients with type 2 diabetes are treated with blood glucose lowering drugs or basal Insulin; HbA1C ≤8.5
Exclusion criteria : patients with type 1 diabetes; diabetic patients unable to do physical activity
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat High way, Tehran
City
Tehran
Postal code
Approval date
2016-08-08, 1395/05/18
Ethics committee reference number
IR.IUMS.REC 1395.9411220005
Health conditions studied
1
Description of health condition studied
Diabetes melitus type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
quality of life
Timepoint
before intervention, 3 month after begining of intervention
Method of measurement
WHO quality of life questionnaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: Prescription of physical activity and life style education, education time : 30 minutes
Category
Lifestyle
2
Description
Control group : life style education, education time : 30 minutes
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Institue of Endocrinology, Iran university of medical sciences
Full name of responsible person
Mohammad Ebrahim Khamseh
Street address
No.10, Firozeh Alley,Valliasr Avenue. Tehran,Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
Hemmat High way, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and technology Iran 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
Iran university of medical sciences
Full name of responsible person
Marzieh Molavi Nojomi
Position
specialist of community medicine/ professor
Other areas of specialty/work
Street address
Department of Community Medicine, Iran University of Medical Sciences, Hemmat High way, Tehran
City
Tehran
Postal code
Phone
+98 21 8860 2225
Fax
Email
mnojomi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran university of medical sciences
Full name of responsible person
Marzieh Molavi Nojomi
Position
specialist of community medicine/ professor
Other areas of specialty/work
Street address
Department of Community Medicine, Iran University of Medical Sciences, Hemmat High Way, Tehran ,
City
Tehran
Postal code
Phone
+98 21 8860 2225
Fax
Email
mnojomi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran university of medical sciences
Full name of responsible person
Marzieh Molavi Nojomi
Position
specialist of community medicine /professor
Other areas of specialty/work
Street address
Department of Community Medicine, Iran University of Medical Sciences, Hemmat High way, Tehran
City
Tehran
Postal code
Phone
+98 21 8860 2225
Fax
Email
mnojomi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)