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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00221208
Other study ID # OHP - 69441
Secondary ID
Status Completed
Phase Phase 1
First received September 13, 2005
Last updated March 16, 2009
Start date April 2005
Est. completion date December 2005

Study information

Verified date March 2009
Source University of Alberta, Physical Education
Contact n/a
Is FDA regulated No
Health authority Canada: Canadian Institutes of Health Research
Study type Interventional

Clinical Trial Summary

This study will investigate the biological and psychosocial benefits of a home-based resistance-training program for sedentary, obese adults living with type 2 diabetes.


Description:

Obese individuals with type 2 diabetes will be randomly assigned to either an experimental group where they will perform moderate to high intensity resistance training (50-60% 1RM weeks 1-3 and 70-85% 1RM in weeks 4-16) three times per week for 16 weeks or to a non-training control group. All resistance training will be performed at home using a multigym apparatus. A personal trainer (PT) will come to the homes of each participant in the experimental group to make sure that exercises are being performed safely with the correct technique, and at the prescribed intensity. In the first two weeks, the PT will come to all 3 sessions per week. In weeks 3-4 this will be reduced to 2 times per week, in weeks 5-8 the PT will come once per week and in the last 8 weeks once bi-weekly.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 75 Years
Eligibility Inclusion Criteria:

Type 2 Diabetes Overweight and Obese (BMI>28) Living inside of City limits

Exclusion Criteria:

Ischemic heart disease Osteoporosis Musculoskeletal abnormalities Currently performing resistance training

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Resistance Training


Locations

Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Alberta, Physical Education

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1c
Primary Muscular strength
Secondary Fasting blood glucose, insulin, lipid concentrations, C-reactive protein, body composition (DEXA), exercise adherence, behaviour change, psychosocial predictors of resistance training, quality of life.
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