Effects of Home-based Resistance Exercise on Body Composition, Muscle Strength and Glycemic Control in People With Type 2 Diabetes.

December 9, 2021 updated by: Dr. Ebaa Al Ozairi, Dasman Diabetes Institute

This study investigates the effects of home-based resistance exercise training, compared to a control group, on body composition, muscle strength and glycaemic control in people with type 2 diabetes.

Half participants will be in the home-based exercise group and half in the control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

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 Locations

  • Kuwait
      • Kuwait City, Kuwait, 15462
        • Dasman Diabetes Institute

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Physician diagnosed type 2 diabetes
  • No changes in anti-diabetic medication in the last 3 months

Exclusion Criteria:

  • Not currently or in the past year participating in any vigorous aerobic activity (>1h per week) or any resistance exercise.
  • BMI of 45 or higher
  • Blood pressure of 160/100mmHg or higher
  • Currently receiving insulin therapy

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual Care
Active Comparator: Home-based
Home-based resistance exercise training
Behavioral: Home-based
Resistance exercise carried out unsupervised at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated Haemoglobin concentration (mmol/mol)
Time Frame: Change from baseline to 32 weeks
Glycated haemaglobin
Change from baseline to 32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat-free mass
Time Frame: Change from baseline to 32 weeks
Whole body fat free mass
Change from baseline to 32 weeks
Short performance physical battery test
Time Frame: Change from baseline to 32 weeks
Short performance physical battery test (0 (worst performance) to 12 (best performance))
Change from baseline to 32 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip strength
Time Frame: Change from baseline to 32 weeks
Grip strength measured by handheld dynamometer
Change from baseline to 32 weeks
One rep max
Time Frame: Change from baseline to 32 weeks
The maximum weight that can be lifted for a single repetition of leg extension and lateral pull down
Change from baseline to 32 weeks
Push up test
Time Frame: Change from baseline to 32 weeks
Number of push ups that can be performed
Change from baseline to 32 weeks
BMI
Time Frame: Change from baseline to 32 weeks
Body mass index
Change from baseline to 32 weeks
Body fat
Time Frame: Change from baseline to 32 weeks
Total body fat measured via DEXA
Change from baseline to 32 weeks
Visceral fat
Time Frame: Change from baseline to 32 weeks
Visceral adipose tissue measured by DEXA
Change from baseline to 32 weeks
Physical activity levels
Time Frame: Change from baseline to 32 weeks
Physical activity levels measured with a wrist worn accelerometer
Change from baseline to 32 weeks
Quality of life score
Time Frame: Change from baseline to 32 weeks
EQ-5D-DL questionnaire will be used (5 (worst) to 125 (best))
Change from baseline to 32 weeks

Collaborators and Investigators

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

Sponsor

Dasman Diabetes Institute

Collaborators

University of Glasgow

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 (Actual)

August 1, 2019

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

October 21, 2019

First Posted (Actual)

October 23, 2019

Study Record Updates

Last Update Posted (Actual)

December 10, 2021

Last Update Submitted That Met QC Criteria

December 9, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-2019-021

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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