Muscle Strength Training for Older Adults With Type II Diabetes

September 11, 2017 updated by: Shirley S.M. Fong, The University of Hong Kong

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Siu Ming Fong, PhD
  • Phone Number: 28315260
  • Email: smfong@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: Muscle Strengthening exercises
Participants will be required to participate in resistance training 3 hours per week.
NO_INTERVENTION: Control group
No exercise training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting glucose level
Time Frame: 4 months
4 months
Lipid profiles
Time Frame: 4 months
HDL, LDL, Trig
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: 4 months
Whole body
4 months
Muscle mass
Time Frame: 4 months
Whole body
4 months
Functional performance
Time Frame: 4 months
Walking ability
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2017

Primary Completion (ANTICIPATED)

January 30, 2019

Study Completion (ANTICIPATED)

August 30, 2019

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

September 11, 2017

First Posted (ACTUAL)

September 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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