Muscle Strength Training for Older Adults With Type II Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Muscle Strengthening exercises
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Resistance training, Diabetes Mellitus, blood-glucose control, Muscle, Function
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Muscle strengthening group
Control group
Arm Description
Participants will be required to perform muscle strengthening exercises 3 hours per week. Close kinetic chain exercises will be performed progressively according to the ACSM guidelines over the 4-month intervention period. The exercise intervention will be conducted by an experienced sports trainer.
No exercise training.
Outcomes
Primary Outcome Measures
Fasting glucose level
Lipid profiles
HDL, LDL, Trig
Secondary Outcome Measures
Muscle strength
Whole body
Muscle mass
Whole body
Functional performance
Walking ability
Full Information
NCT ID
NCT03280758
First Posted
September 5, 2017
Last Updated
September 11, 2017
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03280758
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Anticipated)
Primary Completion Date
January 30, 2019 (Anticipated)
Study Completion Date
August 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Resistance training, Diabetes Mellitus, blood-glucose control, Muscle, Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome assessor will not know the intervention of each subjects
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Muscle strengthening group
Arm Type
Experimental
Arm Description
Participants will be required to perform muscle strengthening exercises 3 hours per week. Close kinetic chain exercises will be performed progressively according to the ACSM guidelines over the 4-month intervention period. The exercise intervention will be conducted by an experienced sports trainer.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No exercise training.
Intervention Type
Behavioral
Intervention Name(s)
Muscle Strengthening exercises
Intervention Description
Participants will be required to participate in resistance training 3 hours per week.
Primary Outcome Measure Information:
Title
Fasting glucose level
Time Frame
4 months
Title
Lipid profiles
Description
HDL, LDL, Trig
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Muscle strength
Description
Whole body
Time Frame
4 months
Title
Muscle mass
Description
Whole body
Time Frame
4 months
Title
Functional performance
Description
Walking ability
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siu Ming Fong, PhD
Phone
28315260
Email
smfong@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siu Ming Fong, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21705072
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.
Results Reference
background
PubMed Identifier
23537893
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.
Results Reference
background
PubMed Identifier
24420336
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.
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
12017678
Citation
American Diabetes Association. Diabetes mellitus and exercise. Diabetes Care. 2000 Jan;23 Suppl 1:S50-4. No abstract available.
Results Reference
background
PubMed Identifier
10912903
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.
Results Reference
background
PubMed Identifier
20093961
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.
Results Reference
background
PubMed Identifier
12905089
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.
Results Reference
background
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Muscle Strength Training for Older Adults With Type II Diabetes
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