NCT04136730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

2.3 years

First QC Date

October 21, 2019

Last Update Submit

December 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Glycated Haemoglobin concentration (mmol/mol)

    Glycated haemaglobin

    Change from baseline to 32 weeks

Secondary Outcomes (2)

  • Fat-free mass

    Change from baseline to 32 weeks

  • Short performance physical battery test

    Change from baseline to 32 weeks

Other Outcomes (8)

  • Grip strength

    Change from baseline to 32 weeks

  • One rep max

    Change from baseline to 32 weeks

  • Push up test

    Change from baseline to 32 weeks

  • +5 more other outcomes

Study Arms (2)

Control

NO INTERVENTION

Usual Care

Home-based

ACTIVE COMPARATOR

Home-based resistance exercise training

Behavioral: Home-based

Interventions

Home-basedBEHAVIORAL

Resistance exercise carried out unsupervised at home

Home-based

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dasman Diabetes Institute

Kuwait City, 15462, Kuwait

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Home Care Services, Hospital-Based

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Home Care ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ebaa AlOzairi

    Dasman Diabetes Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Medical Officer

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 23, 2019

Study Start

August 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

December 10, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations