Back to resultsEffects of Home-based Resistance Exercise on Body Composition, Muscle Strength and Glycemic Control in People With Type 2 Diabetes.
Primary Purpose
Diabetes
Status
Completed
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
Home-based
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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
Sites / Locations
- Dasman Diabetes Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Home-based
Arm Description
Usual Care
Home-based resistance exercise training
Outcomes
Primary Outcome Measures
Glycated Haemoglobin concentration (mmol/mol)
Glycated haemaglobin
Secondary Outcome Measures
Fat-free mass
Whole body fat free mass
Short performance physical battery test
Short performance physical battery test (0 (worst performance) to 12 (best performance))
Full Information
NCT ID
NCT04136730
First Posted
October 21, 2019
Last Updated
December 9, 2021
Sponsor
Dasman Diabetes Institute
Collaborators
University of Glasgow
1. Study Identification
Unique Protocol Identification Number
NCT04136730
Brief Title
Effects of Home-based Resistance Exercise on Body Composition, Muscle Strength and Glycemic Control in People With Type 2 Diabetes.
Official Title
Effects of Home-based Resistance Exercise on Body Composition, Muscle Strength and Glycemic Control in People With Type 2 Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dasman Diabetes Institute
Collaborators
University of Glasgow
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual Care
Arm Title
Home-based
Arm Type
Active Comparator
Arm Description
Home-based resistance exercise training
Intervention Type
Behavioral
Intervention Name(s)
Home-based
Intervention Description
Resistance exercise carried out unsupervised at home
Primary Outcome Measure Information:
Title
Glycated Haemoglobin concentration (mmol/mol)
Description
Glycated haemaglobin
Time Frame
Change from baseline to 32 weeks
Secondary Outcome Measure Information:
Title
Fat-free mass
Description
Whole body fat free mass
Time Frame
Change from baseline to 32 weeks
Title
Short performance physical battery test
Description
Short performance physical battery test (0 (worst performance) to 12 (best performance))
Time Frame
Change from baseline to 32 weeks
Other Pre-specified Outcome Measures:
Title
Grip strength
Description
Grip strength measured by handheld dynamometer
Time Frame
Change from baseline to 32 weeks
Title
One rep max
Description
The maximum weight that can be lifted for a single repetition of leg extension and lateral pull down
Time Frame
Change from baseline to 32 weeks
Title
Push up test
Description
Number of push ups that can be performed
Time Frame
Change from baseline to 32 weeks
Title
BMI
Description
Body mass index
Time Frame
Change from baseline to 32 weeks
Title
Body fat
Description
Total body fat measured via DEXA
Time Frame
Change from baseline to 32 weeks
Title
Visceral fat
Description
Visceral adipose tissue measured by DEXA
Time Frame
Change from baseline to 32 weeks
Title
Physical activity levels
Description
Physical activity levels measured with a wrist worn accelerometer
Time Frame
Change from baseline to 32 weeks
Title
Quality of life score
Description
EQ-5D-DL questionnaire will be used (5 (worst) to 125 (best))
Time Frame
Change from baseline to 32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebaa AlOzairi
Organizational Affiliation
Dasman Diabetes Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dasman Diabetes Institute
City
Kuwait City
ZIP/Postal Code
15462
Country
Kuwait
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32571396
Citation
Al Ozairi E, Alsaeed D, Taliping D, Jalali M, El Samad A, Mashankar A, Taghadom E, Guess N, Gill JMR, Sattar N, Gray C, Welsh P, Gray SR. Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength. Trials. 2020 Jun 22;21(1):557. doi: 10.1186/s13063-020-04480-2. Erratum In: Trials. 2020 Jul 15;21(1):650.
Results Reference
derived
Learn more about this trial
Effects of Home-based Resistance Exercise on Body Composition, Muscle Strength and Glycemic Control in People With Type 2 Diabetes.
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