Effectiveness of a Theory-based Home-based Multi-component Exercise Training Among Older Adults With Type 2 Diabetes Mellitus: Study Protocol of a Sequential Mixed-methods Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- the risk of developing sarcopenia
Study Overview
Brief Summary
The goal of this clinical trial is to learn if a theory-based home-based multi-component exercise training works to prevent sarcopenia in older adults with type 2 diabetes mellitus. It will also learn about the safety of the theory-based home-based multi-component exercise training. The main questions it aims to answer are:
- 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:
· Take a MCE program or a waiting list for 6 months
Detailed Description
Background: Despite international consensus and guidelines recommend multi-component exercise for the older adults to improve their physical function and quality of life. There is a paucity of research exploring the effectiveness and the mechanisms of multi-component exercise in older patients with type 2 diabetes mellitus.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •are community-dwelling older adults aged 60 years or above and have been diagnosed with T2DM;
- •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
- •meet the AWGS 2019 diagnostic criteria for sarcopenia;
- •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,
Outcomes
Primary Outcomes
the risk of developing sarcopenia
Time Frame: baseline, 3 months, 6 months
The change of the scores of Strength, Assistance with Walking, Rise from a Chair, Climb Stairs and Falls (SARC-F) or Assistance with Walking, Rise from a Chair, Climb Stairs and Falls, Calf Circumference (SARC-CalF) or calf circumference (CC) among older adults with type 2 diabetes mellitus during the intervention period and follow-up period. The SARC-F consists of 5 items, which total scores ≥4 points can be judged as patients with high risk of developing sarcopenia. The total scores of SARC-CalF range from 0 to 20, with total scores ≥11 points indicating patients with high risk of developing sarcopenia. AWGS 2019 recommends CC \<34cm for males and CC \<33cm for females to indicate a high risk of developing sarcopenia among Asian populations.
the level of physical activity
Time Frame: baseline, 3 months, 6 months
The change of the scores of physical activity scale for the elderly (PASE) among older adults with type 2 diabetes mellitus during the intervention period and follow-up period. This scale comprises 10 items across three dimensions: leisure, housework, and occupational physical activity. The total scores range from 0 to 500, with higher total scores indicating higher physical activity among the older adults.
Secondary Outcomes
- Fasting blood glucose (FBG)(baseline, 3 months, 6 months)
- muscle strength(baseline, 3 months, 6 months)
- physical performance(baseline, 3 months, 6 months)
- EQ-5D-5L(baseline, 3 months, 6 months)
- depressive mood(baseline, 3 months, 6 months)
- muscle mass,(baseline, 3 months, 6 months)
- cognitive function(baseline, 3 months, 6 months)
- Hemoglobin A1c (HbA1c)(baseline, 3 months, 6 months)
Investigators
Cheng Li
Associate Professor
Sun Yat-sen University