Diabetes Mellitus Type 2NCT06393244
A Theory-based Home-based Multi-component Exercise Training Among Older Adults With Type 2 Diabetes Mellitus
A study testing a theory-based home-based multi-component exercise training in people with Diabetes Mellitus Type 2 and Sarcopenia, run by Cheng Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2, Sarcopenia
- What is being tested?
- a theory-based home-based multi-component exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yuexiu District Baiyun Street community health service center
Guangzhou, Guangdong, 510003
Cheng Li, PhD, 13825020897, chengli5@mail.sysu.edu.cn
Liu Hui, 17812003630, liuh377@mail2.sysu.edu.cn
About this study
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
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.
Read more
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
Read the 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.
- Conditions
- Diabetes Mellitus Type 2, Sarcopenia
- Being tested
- a theory-based home-based multi-component exercise training
- Keywords
- Type 2 diabetes mellitus, The risk of developing Sarcopenia, Multi-component exercise program, Interaction model of client health behavior
- Medical subject headings
- Diabetes Mellitus, Type 2, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a theory-based home-based multi-component exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| the intervention group | Experimental | a theory-based home-based multi-component exercise training Receives: Behavioral: a theory-based home-based multi-component exercise training |
| the waiting list control group | No intervention | the waiting list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
the risk of developing sarcopenia
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.
Measured: baseline, 3 months, 6 months
the level of physical activity
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.
Measured: baseline, 3 months, 6 months
Secondary outcomes (8)
Fasting blood glucose (FBG)
The change of fasting blood glucose among older adults with type 2 diabetes mellitus during the intervention period and follow-up period. The blood samples of participants will be collected by community health service center nurses early in the morning after fasting overnight (at least 8h), for FBG. All determinations will be performed in the same laboratory at the community health service center. FBG will be measured using enzymatic colorimetric assay.
Measured: baseline, 3 months, 6 months
muscle mass,
The change of the scores of muscle mass among older adults with type 2 diabetes mellitus during the intervention period and follow-up period. Bioelectrical impedance analyzer (BIA) is widely used to measure muscle mass in older adults in the community because it is affordable, widely available and portable. A multi-frequency BIA, InBody 120 will be used to estimate body composition including appendicular skeletal muscle mass (ASM). As muscle mass is related to body size, muscle mass will be assessed using the appendicular skeletal muscle mass index (ASMI) (kg/m2), which is height-squared adjusted ASMM.
Measured: baseline, 3 months, 6 months
muscle strength
The change of handgrip strength among older adults with type 2 diabetes mellitus during the intervention period and follow-up period. A digital handgrip strength dynamo-meter will be used to measure handgrip strength in participants. The participants will be instructed to assume a standing position with their hands naturally placed at the side of the body. The dominant and non-dominant hands are then measured twice, with the maximum value recorded.
Measured: baseline, 3 months, 6 months
physical performance
The change of the scores of short physical performance battery (SPPB) among older adults with type 2 diabetes mellitus during the intervention period and follow-up period. The SPPB is a comprehensive tool for testing physical performance, including three parts: balance test, 4-meter walking speed test and 5-time sitting test. The total scores range from 0 to 12, with higher total scores indicating higher physical function among older adults.
Measured: baseline, 3 months, 6 months
cognitive function
The change of the scores of montreal cognitive assessment (MoCA) among older adults with type 2 diabetes mellitus during the intervention period and follow-up period. The MoCA contains 12 items across cognitive tasks for a range of domains, including episodic memory, visuospatial ability, executive function, attention, language and orientation to obtain an overview of one's cognitive function. The total scores range from 0 to 30, with higher total scores indicating better cognitive function.
Measured: baseline, 3 months, 6 months
depressive mood
The change of the scores of 15-item geriatric depression scale (GDS-15) among older adults with type 2 diabetes mellitus during the intervention period and follow-up period. The GDS-15 scale comprises 15 dichotomous questions that describe the primary symptoms of depression, including reduced satisfaction with life, decreased interest in activities, a sense of emptiness in life, loss of hope for the future, decreased energy, and more. The total scores range from 0 to 15, with higher scores indicating more severe depressive symptoms.
Measured: baseline, 3 months, 6 months
EQ-5D-5L
The change of the scores of EuroQol five-dimensional five-level questionnaire (EQ-5D-5L) among older adults with type 2 diabetes mellitus during the intervention period and follow-up period. The EQ-5D-5L comprises five dimensions: mobility (MO), self-care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), each dimension is described at five levels (corresponding roughly to no, slight, moderated, severe, and extreme problems). The total scores range from 0 to 100, with lower total scores indicating better quality of life.
Measured: baseline, 3 months, 6 months
Hemoglobin A1c (HbA1c)
The change of hemoglobin A1c (HbA1c) among older adults with type 2 diabetes mellitus during the intervention period and follow-up period. The blood samples of participants will be collected by community health service center nurses early in the morning after fasting overnight (at least 8h), for HbA1c. All determinations will be performed in the same laboratory at the community health service center. HbA1c will be measured using high-performance liquid chromatography (AKRAY HA 8180V, Menarini Diagnostics).
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start15 Mar 2024
- Primary completionMar 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cheng Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393244
- Sponsor's protocol ID
- L2023SYSU-HL-052
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The non-identified IPD will be shared after outcomes have been published.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06393244
- Acronym / sponsor ID
- L2023SYSU-HL-052
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Cheng LiUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the intervention group | Experimental | Behavioral: a theory-based home-based multi-component exercise traininga theory-based home-based multi-component exercise training |
| the waiting list control group | No intervention | –the waiting list control |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a theory-based home-based multi-component exercise trainingThe 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. | Behavioural | the intervention group |
Primary outcome
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.
8 secondary outcomes
Fasting blood glucose (FBG)
Time frame: baseline, 3 months, 6 months
muscle mass,
Time frame: baseline, 3 months, 6 months
muscle strength
Time frame: baseline, 3 months, 6 months
physical performance
Time frame: baseline, 3 months, 6 months
cognitive function
Time frame: baseline, 3 months, 6 months
depressive mood
Time frame: baseline, 3 months, 6 months
EQ-5D-5L
Time frame: baseline, 3 months, 6 months
Hemoglobin A1c (HbA1c)
Time frame: baseline, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: Yes. The non-identified IPD will be shared after outcomes have been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a theory-based home-based multi-component exercise training in people with Diabetes Mellitus Type 2 and Sarcopenia, run by Cheng Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng Li, PhD (+86 13825020897, chengli5@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the risk of developing sarcopenia (time frame: baseline, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.