Clinical trial NCT06393244: A Theory-based Home-based Multi-component Exercise Training Among Older Adults With Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus Type 2
Sarcopenia
Keywords: Type 2 diabetes mellitus
The risk of developing Sarcopenia
Multi-component exercise program
Interaction model of client health behavior
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 96
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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,

Primary outcomes:
measure: the risk of developing sarcopenia
timeFrame: baseline, 3 months, 6 months
measure: the level of physical activity
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Fasting blood glucose (FBG)
timeFrame: baseline, 3 months, 6 months
measure: muscle mass,
timeFrame: baseline, 3 months, 6 months
measure: muscle strength
timeFrame: baseline, 3 months, 6 months
measure: physical performance
timeFrame: baseline, 3 months, 6 months
measure: cognitive function
timeFrame: baseline, 3 months, 6 months
measure: depressive mood
timeFrame: baseline, 3 months, 6 months
measure: EQ-5D-5L
timeFrame: baseline, 3 months, 6 months
measure: Hemoglobin A1c (HbA1c)
timeFrame: baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Yuexiu District Baiyun Street community health service center
state: Guangdong
Study officials:
References: