This study is done to evaluate the effect of exercise consultation and a period of 6-week exercise therapy on quality of life in patients with type 2 diabetes. A total of 102 cases of patients with diabetes (visited in Firoozgar Hospital Endocrinology Research Center) based on inclusion and exclusion criteria are enrolled in this study. Half of the participants will receive exercise therapy and exercise consultation as group therapy and other group will only receive an educational booklet and a medical examination session individually for exercise prescription. Blood pressure, weight, waist circumference, BMI, fasting plasma glucose, total cholesterol, LDL, HbA1c, TG, and quality of life using the Short Form Health Survey (SF-36) will be assessed at the baseline and after six weeks of the study and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011044251N3
Registration date:2010-12-01, 1389/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-01, 1389/09/10
Registrant information
Name
Haleh Dadgostar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 4050
Email address
dadgostar.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ethics committee in Iran University of Medical Sciences
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercise consultation and exercise therapy on quality of life in patients with type 2 diabetes: A randomized clinical trial
Public title
The effect of group therapy in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: known history of type 2 diabetes, age more than 30 years old, not engaged in physical activity more than 2 hours/week, not receiving insulin, the absence of ST changes in ECG; history of chest pain or pressure, dyspnea on exertion, unexplained gastrointestinal complaints; uncontrolled BP (resting systolic BP >200mmHg or diastolic BP >110mmHg); resting tachycardia (100 beats/min); absence of clinical findings of diabetic micro- or macrovascular complications (retinopathy, autonomic neuropathy, nephropathy), Not orthopedic problem for patient’s activity, ability to read and speak in Persian
Exclusion criteria: taking glucocorticoids, absence in more than one session of group therapy session
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single 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 in Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Postal code
5983-14155
Approval date
2010-10-24, 1389/08/02
Ethics committee reference number
896/5
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Quality of life
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
The short form health survay (SF-36)
2
Description
TG
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
Blood sample
3
Description
HDL
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
Blood sample
4
Description
LDL
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
Blood sample
5
Description
Total cholestrol
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
Blood sample
6
Description
Diastolic pressure
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
Sphygmomanometer
7
Description
FBS
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
Blood sample
8
Description
systolic blood pressure
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
Sphygmomanometer
9
Description
Hb A1c
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
Blood sample
10
Description
weight
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
scale
11
Description
BMI
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
weight(kg)/Square of height(meter)
12
Description
waist circumference
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
meter
13
Description
Physical functioning
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
The short form health survey(SF-36)
14
Description
Role physical
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
The short form health survey(SF-36)
15
Description
Social functioning
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
The short form health survey(SF-36)
16
Description
Mental health
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
The short form health survey(SF-36)
17
Description
Bodily pain
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
The short form health survey(SF-36)
18
Description
Vitality
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
The short form health survey(SF-36)
19
Description
General health
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
The short form health survey(SF-36)
20
Description
Role emotional
Timepoint
before intervention and after 6 weeks of intervention
Method of measurement
The short form health survey(SF-36)
Secondary outcomes
empty
Intervention groups
1
Description
The control group will only receive an educational booklet, and a systematic intervention program will not be given. They have just one session (30 minutes) by sports medicine specialist about health screening, education of booklet and exercise prescription, individually. They don’t have another session during 6 weeks of the study. Also, consultation to change other aspects of lifestyle (nutrition and diet consultation) will be given to all patients.
Category
Lifestyle
2
Description
The intervention group: The 6-week group therapy will be provided in 6 sessions once a week by sports medicine specialist (2 hours) consisted of: health screening (blood pressure and body weight check), education, exercise prescription and counseling. Also, once a week, contact with participants by phone will be done for giving necessary recommendations about exercise training by sports medicine specialist. Exercise program will be 3 sessions per week consisted of warm-up, stretching, strength training, aerobic and cool-down exercises for 60 minutes per session. Participants will be encouraged to perform walking exercise in other days. Also, consultation to change other aspects of lifestyle (nutrition and diet consultation) will be given to all patients. The patients can call during the week for receiving the necessary exercise consultation.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital Endocrinology Research Center
Full name of responsible person
Sahar Firouzinezhad MD.Assistant of sports medicine
Street address
Beh Afarin street -Karim khan zand street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences (Research Department)
Full name of responsible person
Abbas Motavalian, MD
Street address
Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences (Research Department)