| Registry | NCT04136730 |
|---|
| Status | Completed |
|---|
| Phase | Not applicable |
|---|
| Study type | Interventional; randomized, parallel, masking: none, treatment |
|---|
| Enrollment | 126 (Actual) |
|---|
| Sponsor | Dasman Diabetes Institute (Other); collaborators: University of Glasgow |
|---|
| Conditions | Diabetes |
|---|
| Interventions | Home-based (Behavioral) |
|---|
| Dates | start 2019-08-01, primary completion 2021-12-01, completion 2021-12-01, first posted 2019-10-23, last updated 2021-12-10 |
|---|
| Locations | 1 site in Kuwait |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Diabetes All trials of Home-based
-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.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Control | No intervention | | Usual Care |
| Home-based | Active comparator | Behavioral: Home-based | Home-based resistance exercise training |
- Home-based (Behavioral): Resistance exercise carried out unsupervised at home
+Outcome measures
Primary outcomes
- Glycated Haemoglobin concentration (mmol/mol) [Change from baseline to 32 weeks]: Glycated haemaglobin
Secondary outcomes
- Fat-free mass [Change from baseline to 32 weeks]: Whole body fat free mass
- Short performance physical battery test [Change from baseline to 32 weeks]: Short performance physical battery test (0 (worst performance) to 12 (best performance))
Other outcomes
- Grip strength [Change from baseline to 32 weeks]: Grip strength measured by handheld dynamometer
- One rep max [Change from baseline to 32 weeks]: The maximum weight that can be lifted for a single repetition of leg extension and lateral pull down
- Push up test [Change from baseline to 32 weeks]: Number of push ups that can be performed
- BMI [Change from baseline to 32 weeks]: Body mass index
- Body fat [Change from baseline to 32 weeks]: Total body fat measured via DEXA
- Visceral fat [Change from baseline to 32 weeks]: Visceral adipose tissue measured by DEXA
- Physical activity levels [Change from baseline to 32 weeks]: Physical activity levels measured with a wrist worn accelerometer
- Quality of life score [Change from baseline to 32 weeks]: EQ-5D-DL questionnaire will be used (5 (worst) to 125 (best))
+Eligibility
Sex: All, ages: 21 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
|---|
| Dasman Diabetes Institute | Kuwait City | Kuwait | |
+Publications
- Results publication: 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. PMID 32571396
+Investigators