Comparison of two exercise- therapy programs on indices of muscular strength in female type 2 diabetes mellitus patients: a double blind randomized controlled trial.
This study is a double-blind controlled trial to investigate and comparison of the effects of two exercise-therapy protocols on indices of isokinetic muscular strength in a total of 40 female volunteers with type 2 diabetes mellitus aged 30-60 years with and HbA1C=7.5-10% and treated with oral antidiabetic agents and no major cardiovascular risk factor or other contraindications to moderate to high intensity endurance and resistance exercises.
The subjects will be randomized to two groups of twenty each. The intervention group will receive 12 weeks of supervised endurance and resistance exercises, while the control group will be receiving a home-based individualized endurance and resistance exercise program for the same duration of time. Both of the abovementioned protocols will be complying with American of Sports Medicine and American Diabetes Association guidelines
In both groups concentric and eccentric peak torque, and concentric and eccentric average torque of non-dominant knee extensors at three different angular velocities will be measured and compared before and after the interventions using a Biodex® isokinetic dynamometry system.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104256283N1
Registration date:2011-12-27, 1390/10/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-27, 1390/10/06
Registrant information
Name
Mojtaba Malek
Name of organization / entity
Institute of Endocrinology and Metabolism, Endocrine research center(Firozgar), Tehram University of
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 5247
Email address
malekmoj@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2012-11-22, 1391/09/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two exercise- therapy programs on indices of muscular strength in female type 2 diabetes mellitus patients: a double blind randomized controlled trial.
Public title
Comparison of two exercise- therapy programs on indices of muscular strength in female type 2 diabetes mellitus patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Type 2 diabetes mellitus; Age range: 30-55 years; Female; Treated by Oral Anti Diabetic agents; HbA1C=8-10%.
Exclusion criteria: High blood pressure; Insulin therapy; B-Blocker agents; Ca- Channel blockers; Nitrates; Cardio Vascular Diseases; Micro vascular and Macro vascular side effects of Diabetes Mellitus; History of moderate to sever muscoloskeletal disorders;Anemia (Hb lower than12); Pregnancy;Tobacco smoking; Alcohol abuse.
Age
From 30 years old to 55 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 of Tehran University of Medical Sciences
Street address
Keshavarz Blv., Poorsina Building, Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
12667
Health conditions studied
1
Description of health condition studied
Exercise therapy programs in Non-insulin-dependent diabetes mellitus type II
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Strenght changes of concentric and eccentric muscles
Timepoint
72-96 hours before the initiation of the protocols , 72-96 hours after the conclusion of the protocols.
Method of measurement
Isokinetic test by Kin Kam device
Secondary outcomes
1
Description
Eccentric average torque of non-dominant knee extensors.
Timepoint
72-96 hours before the initiation of the protocols , 72-96 hours after the conclusion of the protocols.
Method of measurement
Isokinetic test
2
Description
Maximal concentric angular velocity of non-dominant knee extensors.
Timepoint
72-96 hours before the initiation of the protocols , 72-96 hours after the conclusion of the protocols.
Method of measurement
Isokinetic test
3
Description
Eccentric peak torque of non-dominant knee extensors.
Timepoint
72-96 hours before the initiation of the protocols , 72-96 hours after the conclusion of the protocols.
Method of measurement
Isokinetic test
4
Description
Concentric avereage torque of non-dominant knee extensors
Timepoint
72-96 hours before the initiation of the protocols , 72-96 hours after the conclusion of the protocols.
Method of measurement
Isokinetic test
5
Description
Maximal eccentric angular velocity of non-dominant knee extensors.
Timepoint
72-96 hours before the initiation of the protocols , 72-96 hours after the conclusion of the protocols.
Method of measurement
Isokinetic test
Intervention groups
1
Description
Supervised exercise protocol (SEP)
Category
Other
2
Description
Home-based exercise protocol (HEP)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Institute of Endocrinology and Metabolism, Endorine Research center(Firozgar)