Back to resultsResistance Training in Diabetic Elder Patients
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Resistance exercise
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes mellitus, Resistance exercise, Elderly, Skeletal muscle dysfunction, Metabolomics
Eligibility Criteria
Inclusion Criteria:
- 65 years old or older
- no clinical diagnosis of cardiovascular disease
- patients with or without type 2 diabetes mellitus
Exclusion Criteria:
- glycated hemoglobin > 10%
- pulmonary disease
- cancer
- cognitive dysfunction
- any neurological or musculoskeletal disease that will affect exercise performance
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual care
Resistance exercise
Arm Description
Participants in this arm will receive a brochure specific for type 2 diabetes mellitus about the general principles of exercise, nutrition, and diet. They are asked to maintain their activity level.
Progressive resistance training, 3 times a week for 12 weeks
Outcomes
Primary Outcome Measures
Maximal muscle strength
This outcome measure includes upper and lower body maximal muscle strength.
Secondary Outcome Measures
Physical body function
This outcome will be assessed by one minute sit-to-stand test and timed "Up and Go" test.
Quality of life
This outcome measure will be assessed by the diabetes-specific questionnaire.
Waist circumference
Body mass index
This outcome measure includes the measurements of body height and body weight.
Functional capacity
Peak oxygen consumption will be determined by graded exercise test to assess functional capacity.
Blood biochemical parameters
This outcome measure includes the analysis of fasting glucose, glycated hemoglobin, lipid profile, C-reactive protein, and related metabolites.
Muscle oxygenation
Muscle oxygenation will be assessed during exercise
Full Information
NCT ID
NCT01638351
First Posted
July 8, 2012
Last Updated
November 15, 2012
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01638351
Brief Title
Resistance Training in Diabetic Elder Patients
Official Title
Effects of Resistance Training on Muscle Dysfunction in Elderly Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effect of a 12-week progressive resistance training program on the skeletal muscle function, glycemic control, functional capacity, and quality of life in the elderly with type 2 diabetes mellitus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes mellitus, Resistance exercise, Elderly, Skeletal muscle dysfunction, Metabolomics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive a brochure specific for type 2 diabetes mellitus about the general principles of exercise, nutrition, and diet. They are asked to maintain their activity level.
Arm Title
Resistance exercise
Arm Type
Experimental
Arm Description
Progressive resistance training, 3 times a week for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Resistance exercise
Intervention Description
Progressive resistance exercise training, 3 times a week for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Participants in this arm will receive a brochure specific for type 2 diabetes mellitus about the general principles of exercise, nutrition, and diet. They are asked to maintain their activity level.
Primary Outcome Measure Information:
Title
Maximal muscle strength
Description
This outcome measure includes upper and lower body maximal muscle strength.
Time Frame
Twelve weeks
Secondary Outcome Measure Information:
Title
Physical body function
Description
This outcome will be assessed by one minute sit-to-stand test and timed "Up and Go" test.
Time Frame
Twelve weeks
Title
Quality of life
Description
This outcome measure will be assessed by the diabetes-specific questionnaire.
Time Frame
Twelve weeks
Title
Waist circumference
Time Frame
Twelve weeks
Title
Body mass index
Description
This outcome measure includes the measurements of body height and body weight.
Time Frame
Twelve weeks
Title
Functional capacity
Description
Peak oxygen consumption will be determined by graded exercise test to assess functional capacity.
Time Frame
Twelve weeks
Title
Blood biochemical parameters
Description
This outcome measure includes the analysis of fasting glucose, glycated hemoglobin, lipid profile, C-reactive protein, and related metabolites.
Time Frame
Twevle weeks
Title
Muscle oxygenation
Description
Muscle oxygenation will be assessed during exercise
Time Frame
Twelve weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
65 years old or older
no clinical diagnosis of cardiovascular disease
patients with or without type 2 diabetes mellitus
Exclusion Criteria:
glycated hemoglobin > 10%
pulmonary disease
cancer
cognitive dysfunction
any neurological or musculoskeletal disease that will affect exercise performance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying-Tai Wu, Ph.D.
Organizational Affiliation
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University (R.O.C.)
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
12453982
Citation
Castaneda C, Layne JE, Munoz-Orians L, Gordon PL, Walsmith J, Foldvari M, Roubenoff R, Tucker KL, Nelson ME. A randomized controlled trial of resistance exercise training to improve glycemic control in older adults with type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2335-41. doi: 10.2337/diacare.25.12.2335.
Results Reference
background
PubMed Identifier
12351469
Citation
Dunstan DW, Daly RM, Owen N, Jolley D, De Courten M, Shaw J, Zimmet P. High-intensity resistance training improves glycemic control in older patients with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1729-36. doi: 10.2337/diacare.25.10.1729.
Results Reference
background
PubMed Identifier
12902533
Citation
Brandon LJ, Gaasch DA, Boyette LW, Lloyd AM. Effects of long-term resistive training on mobility and strength in older adults with diabetes. J Gerontol A Biol Sci Med Sci. 2003 Aug;58(8):740-5. doi: 10.1093/gerona/58.8.m740.
Results Reference
background
PubMed Identifier
19157617
Citation
Cheung NW, Cinnadaio N, Russo M, Marek S. A pilot randomised controlled trial of resistance exercise bands in the management of sedentary subjects with type 2 diabetes. Diabetes Res Clin Pract. 2009 Mar;83(3):e68-71. doi: 10.1016/j.diabres.2008.12.009. Epub 2009 Jan 20.
Results Reference
background
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Resistance Training in Diabetic Elder Patients
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