Muscle Strength Training for Older Adults With Type II Diabetes

NCT ID: NCT03280758

Last Updated: 2017-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-08-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessor will not know the intervention of each subjects

Study Groups

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Muscle strengthening group

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.

Group Type EXPERIMENTAL

Muscle Strengthening exercises

Intervention Type BEHAVIORAL

Participants will be required to participate in resistance training 3 hours per week.

Control group

No exercise training.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Muscle Strengthening exercises

Participants will be required to participate in resistance training 3 hours per week.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Shirley S.M. Fong

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Siu Ming Fong, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Central Contacts

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Siu Ming Fong, PhD

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 21705072 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23537893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24420336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12351469 (View on PubMed)

American Diabetes Association. Diabetes mellitus and exercise. Diabetes Care. 2000 Jan;23 Suppl 1:S50-4. No abstract available.

Reference Type BACKGROUND
PMID: 12017678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10912903 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20093961 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12905089 (View on PubMed)

Other Identifiers

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02

Identifier Type: -

Identifier Source: org_study_id

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