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

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ClinicalTrials.gov Identifier: NCT04136730
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : July 20, 2020
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
Dr. Ebaa Al Ozairi, Dasman Diabetes Institute

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.


Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Home-based Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Home-based Resistance Exercise on Body Composition, Muscle Strength and Glycemic Control in People With Type 2 Diabetes.
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Glycated Haemoglobin concentration (mmol/mol) [ Time Frame: Change from baseline to 32 weeks ]
    Glycated haemaglobin


Secondary Outcome Measures :
  1. Fat-free mass [ Time Frame: Change from baseline to 32 weeks ]
    Whole body fat free mass

  2. 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))


Other Outcome Measures:
  1. Grip strength [ Time Frame: Change from baseline to 32 weeks ]
    Grip strength measured by handheld dynamometer

  2. 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

  3. Push up test [ Time Frame: Change from baseline to 32 weeks ]
    Number of push ups that can be performed

  4. BMI [ Time Frame: Change from baseline to 32 weeks ]
    Body mass index

  5. Body fat [ Time Frame: Change from baseline to 32 weeks ]
    Total body fat measured via DEXA

  6. Visceral fat [ Time Frame: Change from baseline to 32 weeks ]
    Visceral adipose tissue measured by DEXA

  7. Physical activity levels [ Time Frame: Change from baseline to 32 weeks ]
    Physical activity levels measured with a wrist worn accelerometer

  8. Quality of life score [ Time Frame: Change from baseline to 32 weeks ]
    EQ-5D-DL questionnaire will be used (5 (worst) to 125 (best))



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04136730


Contacts
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Contact: Stuart Gray 01413302569 stuart.gray@glasgow.ac.uk

Locations
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Kuwait
Dasman Diabetes Institute Recruiting
Kuwait City, Kuwait, 15462
Contact: Nicola Guess, PhD    +965 2224 2999 ext 2033    Nicola.Guess@dasmaninstitute.org   
Sponsors and Collaborators
Dasman Diabetes Institute
University of Glasgow
Investigators
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Principal Investigator: Ebaa AlOzairi Dasman Diabetes Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Ebaa Al Ozairi, Chief Medical Officer, Dasman Diabetes Institute
ClinicalTrials.gov Identifier: NCT04136730    
Other Study ID Numbers: HM-2019-021
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases