A Theory-based Home-based Multi-component Exercise Training Among Older Adults With Type 2 Diabetes Mellitus
NCT ID: NCT06393244
Last Updated: 2024-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
96 participants
INTERVENTIONAL
2024-03-15
2025-07-31
Brief Summary
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* Whether a 12-week theory-based home-based MCE program is effective in decreasing the risk of developing sarcopenia, as well as improving physical activity, glycaemic control, muscle mass, muscle strength, physical performance, cognitive function, depressive mood, and quality of life among the Chinese community-dwelling older patients with T2DM.
* What are the underlying mechanisms of the exercise intervention.
Researchers will compare the MCE program to a waiting list control group to see if the MCE program works to prevent sarcopenia.
Participants will:
ยท Take a MCE program or a waiting list for 6 months
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Detailed Description
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Aim: To evaluate the effectiveness of a 12-week theory-based home-based multi-component exercise program for Chinese community-dwelling older adults with type 2 diabetes mellitus, and to clarify the underlying mechanisms of the exercise intervention in this population.
Design: This study adopted a sequential mixed-methods design comprising a prospective, two-arm, assessor-blinded randomised controlled trial and a descriptive qualitative study.
Methods: A total of 96 eligible patients will be recruited from a community health service center in Guangzhou, China. And they will be randomly assigned to the intervention group or the waiting list control group with block randomization at a 1:1 ratio after baseline measurement. Participants in the intervention group will receive a 12-week theory-based home-based multi-component exercise program. The primary outcomes are the risk of sarcopenia and physical activity. Secondary outcomes include glycaemic control (measured by FBG and HbA1c), muscle mass, muscle strength, physical performance, cognitive function, depressive mood, quality of life. Data will be collected at baseline (T0), post-intervention (T1), 3 months after the intervention (T2). Intervention effects will be analyzed using the generalized estimating equation model on the basis of the intention-to-treat principle. For the qualitative study, individual semi-structured interviews will be conducted with some participants based on maximum variation principle in the intervention group. Content analysis methods will be used to analyze the qualitative data to explore the underlying mechanisms of the intervention.
Discussion: This study is expected to provide an effective and practical intervention to prevent or control sarcopenia among Chinese community-dwelling older adults with type 2 diabetes mellitus. The results of this study will demonstrate the effectiveness and potential mechanisms of multicomponent exercise, contributing to the existing evidence in this filed.
Impact: This study will provide useful evidence for health professionals to provide health care and early intervention for older patients with T2DM to prevent or control sarcopenia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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the intervention group
a theory-based home-based multi-component exercise training
a theory-based home-based multi-component exercise training
The participants in the intervention group will receive a 12-week theory-based home-based MCE program, which consists of three phases: exercise mobilization phase, exercise preparation phase (exercise instructions and exercise plan determination), and home-based autonomous exercise training. Structured guidelines have been developed for the intervention by the research team. This allowed interveners to deliver the intervention in a structured way with the same dosage.
the waiting list control group
the waiting list control
No interventions assigned to this group
Interventions
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a theory-based home-based multi-component exercise training
The participants in the intervention group will receive a 12-week theory-based home-based MCE program, which consists of three phases: exercise mobilization phase, exercise preparation phase (exercise instructions and exercise plan determination), and home-based autonomous exercise training. Structured guidelines have been developed for the intervention by the research team. This allowed interveners to deliver the intervention in a structured way with the same dosage.
Eligibility Criteria
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Inclusion Criteria
* are able to communicate in Chinese;
* have a smartphone to receive intervention materials and messages;
* provide written informed consent for voluntary participation in this study.
Exclusion Criteria
* are currently participating in any other exercise intervention program or within the last 6 months;
* have any contraindication to exercise training according to the American College of Sports Medicine (ACSM) or are medically prohibited from participating in exercise;
* have a history of cognitive disorders or psychopathy, as identified in their medical records;
* severe visual or hearing problems,
60 Years
100 Years
ALL
Yes
Sponsors
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Cheng Li
OTHER
Responsible Party
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Cheng Li
Associate Professor
Locations
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Yuexiu District Baiyun Street community health service center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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L2023SYSU-HL-052
Identifier Type: -
Identifier Source: org_study_id
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