Clinical trial NCT03280758: Muscle Strength Training for Older Adults With Type II Diabetes
Official title: Effects of Muscle Strength Training on Glycemic Control, Muscle Mass, Muscle Strength and Functional Capacity in Older Adults With Type II Diabetes: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Resistance training
Diabetes Mellitus
blood-glucose control
Muscle
Function
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomised controlled trial aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with Type II Diabetes (T2 DM).

60 subjects will be randomly allocated to either a muscle strengthening group or a no exercise control group.

Muscle strengthening group will receive resistance training 3 times per week (1 hour/session).

The control group will not receive any training but can continue usual medical care and daily activities.

Primary outcomes: glycemic control and lipid profile Secondary outcomes: muscle mass and strength, and functional capacity Data will be collected at baseline (pre-test) and after a 4-month intervention (post-test).

Detailed description: This study aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with Type II Diabetes (T2 DM).

This is a single-blinded, randomized controlled trial. 60 subjects will be randomly allocated to either a muscle strengthening group or a no exercise control group.

Information on demographic characteristics, body composition, muscle strength, functional capacity and glycemic control will be collected at baseline (pre-test) and after a 4-month intervention (post-test). Muscle strengthening group will receive resistance training 3 times per week (1 hour/session).

The control group will not receive any training but can continue usual medical care and daily activities.

Eligibility criteria: Inclusion Criteria:

* T2 DM
* 60-75 years old
* ability to perform exercise

Exclusion Criteria:

* Advanced hypertension (≥ 160/100 mm Hg)
* severe obesity (BMI ≥ 48kg/m2)
* insulin pump user
* coronary heart disease history
* chronic obstructive pulmonary disease
* advanced neuropathy
* learning or mental disorder, or
* any other diseases that prevent subjects from exercising safely.
* Those who participate in regular resistance or aerobic exercises will also be excluded.

Primary outcomes:
measure: Fasting glucose level
timeFrame: 4 months
measure: Lipid profiles
timeFrame: 4 months
Secondary outcomes:
measure: Muscle strength
timeFrame: 4 months
measure: Muscle mass
timeFrame: 4 months
measure: Functional performance
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: The University of Hong Kong
name: Siu Ming Fong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nolan CJ, Damm P, Prentki M. Type 2 diabetes across generations: from pathophysiology to prevention and management. Lancet. 2011 Jul 9;378(9786):169-81. doi: 10.1016/S0140-6736(11)60614-4. Epub 2011 Jun 24.
citation: Leenders M, Verdijk LB, van der Hoeven L, Adam JJ, van Kranenburg J, Nilwik R, van Loon LJ. Patients with type 2 diabetes show a greater decline in muscle mass, muscle strength, and functional capacity with aging. J Am Med Dir Assoc. 2013 Aug;14(8):585-92. doi: 10.1016/j.jamda.2013.02.006. Epub 2013 Mar 26.
citation: Shishikura K, Tanimoto K, Sakai S, Tanimoto Y, Terasaki J, Hanafusa T. Association between skeletal muscle mass and insulin secretion in patients with type 2 diabetes mellitus. Endocr J. 2014;61(3):281-7. doi: 10.1507/endocrj.ej13-0375. Epub 2014 Jan 10.
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.
citation: American Diabetes Association. Diabetes mellitus and exercise. Diabetes Care. 2000 Jan;23 Suppl 1:S50-4. No abstract available.
citation: Albright A, Franz M, Hornsby G, Kriska A, Marrero D, Ullrich I, Verity LS. American College of Sports Medicine position stand. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2000 Jul;32(7):1345-60. doi: 10.1097/00005768-200007000-00024.
citation: Black LE, Swan PD, Alvar BA. Effects of intensity and volume on insulin sensitivity during acute bouts of resistance training. J Strength Cond Res. 2010 Apr;24(4):1109-16. doi: 10.1519/JSC.0b013e3181cbab6d.
citation: Baldi JC, Snowling N. Resistance training improves glycaemic control in obese type 2 diabetic men. Int J Sports Med. 2003 Aug;24(6):419-23. doi: 10.1055/s-2003-41173.