Resistance Training in Diabetic Elder Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effects of Resistance Training on Muscle Dysfunction in Elderly Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638351
• Other study ID #: 201110029RC
• Status: Completed
• Phase: N/A
• First received: July 8, 2012
• Last updated: November 15, 2012
• Start date: December 2011
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Resistance exercise
Progressive resistance exercise training, 3 times a week for 12 weeks.
• Usual care
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal muscle strength	This outcome measure includes upper and lower body maximal muscle strength.	Twelve weeks	No
Secondary	Physical body function	This outcome will be assessed by one minute sit-to-stand test and timed "Up and Go" test.	Twelve weeks	No
Secondary	Quality of life	This outcome measure will be assessed by the diabetes-specific questionnaire.	Twelve weeks	No
Secondary	Waist circumference		Twelve weeks	No
Secondary	Body mass index	This outcome measure includes the measurements of body height and body weight.	Twelve weeks	No
Secondary	Functional capacity	Peak oxygen consumption will be determined by graded exercise test to assess functional capacity.	Twelve weeks	No
Secondary	Blood biochemical parameters	This outcome measure includes the analysis of fasting glucose, glycated hemoglobin, lipid profile, C-reactive protein, and related metabolites.	Twevle weeks	No
Secondary	Muscle oxygenation	Muscle oxygenation will be assessed during exercise	Twelve weeks	No