Type 2 Diabetes Mellitus (T2DM)NCT07255222
Effects of a Multimodal Exercise Program on Physical Performance and Muscle Function in Middle-aged Patients With T2DM
A study testing A Multimodal Exercise Intervention in people with Type 2 Diabetes Mellitus (T2DM), run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
Background Middle-aged adults with type 2 diabetes mellitus (T2DM), especially in Asian populations, are at increased risk of sarcopenia, reduced muscle function, and decline in physical performance. Effective and feasible exercise interventions are needed to support early prevention and healthy aging. Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- A Multimodal Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Aug 2025to 14 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with Type 2 Diabetes Mellitus and on stable oral hypoglycemic medication.
- Middle-aged adults between 45 and 64 years old.
- Able to communicate in Mandarin or Taiwanese.
- Willing to provide informed consent or have informed consent obtained from a proxy
Who cannot join
- Limited limb or joint function (e.g., fractures or dislocations).
- Communication or emotional issues, such as depression or mental illness.
- Severe cognitive impairment, such as dementia.
- End-stage renal disease.
- Major comorbidities or complications, including diabetic foot, amputation, myocardial infarction, autonomic neuropathy, and a history of stroke within the last 3 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Multimodal Exercise Program on Physical Performance and Muscle Function in Middle-Aged Patients With Type 2 Diabetes: A Multicenter Randomized Controlled Trial
Background Middle-aged adults with type 2 diabetes mellitus (T2DM), especially in Asian populations, are at increased risk of sarcopenia, reduced muscle function, and decline in physical performance. Effective and feasible exercise interventions are needed to support early prevention and healthy aging.
Methods This is a multicenter randomized controlled trial. The study plans to recruit 66 adults aged 45 to 64 years with a confirmed diagnosis of T2DM. Participants will be randomly assigned to either a control group or an intervention group. The control group will receive a Nutrition and Muscle Health Education Sheet and continue routine health management. The intervention group will receive the same education sheet, a Diabetes and Muscle Health Handbook, and a 12-week multimodal exercise program. From Week 13 to Week 24, app-based maintenance reminders will be provided every two weeks.
Read more
All participants will be assessed at baseline (Week 0), Week 6, Week 12, and Week 24. The Week 6 assessment is a mid-intervention assessment, the Week 12 assessment evaluates immediate post-intervention effects, and the Week 24 assessment evaluates sustained effects during the maintenance phase. Assessments include physical performance, muscle function, glycated hemoglobin (HbA1c), health-related quality of life, and the risk of sarcopenia. No additional invasive tests or additional research procedures will be introduced at Week 24.
Outcome Measures The primary outcomes are physical performance and muscle function, including the Short Physical Performance Battery (SPPB), Five-Time Sit-to-Stand Test (5TSTS), handgrip strength, and Skeletal Muscle Index (SMI). Secondary outcomes include HbA1c, health-related quality of life measured by the SF-12, and sarcopenia risk assessed by SARC-CalF.
Expected Outcomes This study aims to provide an evidence-based and feasible multimodal exercise prescription for middle-aged adults with T2DM and to support early intervention strategies for healthy aging.
Read the detailed description
Primary Outcomes
Physical Function:
Physical performance was assessed using the Short Physical Performance Battery (SPPB), which evaluates lower extremity function through three subtests: balance, gait speed, and chair-stand performance. Each component was scored from 0 to 4, with a total score ranging from 0 to 12, where higher scores indicate better physical performance.
The Five-Times Sit-to-Stand Test (5TSTS) was also used to assess lower limb muscle strength and functional mobility. Participants were instructed to rise from a standard chair (seat height 43-45 cm) to a full standing position and return to sitting five consecutive times as quickly as possible without using their arms. The total time required was recorded in seconds, with longer times indicating poorer performance.
Muscle Strength and Mass:
Handgrip strength was measured using a digital dynamometer (e.g., Jamar or equivalent model) as an indicator of upper limb muscle strength. Participants performed the test in a standing position with the arm fully extended at the side and were instructed to exert maximum force for 3-5 seconds. Two trials were performed for each hand, and the highest value (kg) was used for analysis. Low muscle strength was defined according to the Asian Working Group for Sarcopenia (AWGS 2019) criteria (<28 kg for men and <18 kg for women).
Skeletal Muscle Mass Index (SMI) was determined by bioelectrical impedance analysis (BIA; e.g., InBody 720 or equivalent). Appendicular skeletal muscle mass (ASM, kg) was calculated as the sum of lean mass from both arms and legs. SMI was expressed as ASM divided by height squared (kg/m²). Low muscle mass was defined according to the AWGS 2019 cut-off values (<7.0 kg/m² for men and <5.7 kg/m² for women).
Secondary Outcomes
Metabolic Control:
Glycemic control was evaluated by measuring glycated hemoglobin (HbA1c) levels. Venous blood samples were collected after an overnight fast and analyzed using a standardized high-performance liquid chromatography (HPLC) method. HbA1c values were expressed as percentages according to the National Glycohemoglobin Standardization Program (NGSP) guidelines.
Quality of Life:
Health-related quality of life was assessed using the 12-Item Short Form Health Survey (SF-12). This validated questionnaire consists of 12 items covering eight domains, which are summarized into two composite scores: the Physical Component Summary (PCS) and Mental Component Summary (MCS). Scores were calculated according to the standard scoring manual, with higher scores representing better quality of life.
Sarcopenia Risk Assessment:
Risk of sarcopenia was screened using the SARC-CalF questionnaire, which combines the five-item SARC-F (strength, assistance in walking, rising from a chair, climbing stairs, and falls) with calf circumference measurement. Each item of SARC-F was scored from 0 to 2, yielding a total score ranging from 0 to 10. Calf circumference was measured at the widest point of the right leg using a non-elastic tape, with values ≤34 cm for men and ≤33 cm for women, adding 10 points to the SARC-F score. A total SARC-CalF score ≥11 indicated a high risk of sarcopenia.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- A Multimodal Exercise Intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Multimodal Exercise InterventionBehavioural
Participants will receive educational materials and participate in a 12-week multimodal exercise program, followed by app-supported maintenance reminders every two weeks through Week 24.
| Study group | Role | What they receive |
|---|---|---|
| A Multimodal Exercise Intervention | Experimental | Participants in this group will receive a Diabetes and Muscle Health Handbook and participate in a 12-week multimodal exercise program, including supervised instruction, home-based exercise, and digital support. From Week 13 to Week 24, app-based maintenance reminders will be provided every two weeks. Receives: Behavioral: A Multimodal Exercise Intervention |
| control group | No intervention | Participants in this group will serve as the control for the study. At the beginning of the study, they will only receive a "Nutrition and Muscle Health Education Sheet". They will not participate in the multimodal exercise program and will continue with their usual health management based on existing medical advice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
Physical performance was assessed using the Short Physical Performance Battery (SPPB), which evaluates lower extremity function through three subtests: balance, gait speed, and chair-stand performance. Each component was scored from 0 to 4, with a total score ranging from 0 to 12, where higher scores indicate better physical performance.
Measured: All participants will be assessed at baseline, Week 6, Week 12, and Week 24.
Five-Times Sit-to-Stand Test (5TSTS)
The Five-Times Sit-to-Stand Test (5TSTS) was also used to assess lower limb muscle strength and functional mobility. Participants were instructed to rise from a standard chair (seat height 43-45 cm) to a full standing position and return to sitting five consecutive times as quickly as possible without using their arms. The total time required was recorded in seconds, with longer times indicating poorer performance.
Measured: All participants will be assessed at baseline, Week 6, Week 12, and Week 24.
Handgrip strength
Handgrip strength was measured using a digital dynamometer (e.g., Jamar or equivalent model) as an indicator of upper limb muscle strength. Participants performed the test in a standing position with the arm fully extended at the side and were instructed to exert maximum force for 3-5 seconds. Two trials were performed for each hand, and the highest value (kg) was used for analysis. Low muscle strength was defined according to the Asian Working Group for Sarcopenia (AWGS 2019) criteria (<28 kg for men and <18 kg for women).
Measured: All participants will be assessed at baseline, Week 6, Week 12, and Week 24.
Skeletal Muscle Mass Index (SMI)
Skeletal Muscle Mass Index (SMI) was determined by bioelectrical impedance analysis (BIA; e.g., InBody 720 or equivalent). Appendicular skeletal muscle mass (ASM, kg) was calculated as the sum of lean mass from both arms and legs. SMI was expressed as ASM divided by height squared (kg/m²). Low muscle mass was defined according to the AWGS 2019 cut-off values (<7.0 kg/m² for men and <5.7 kg/m² for women).
Measured: All participants will be assessed at baseline, Week 6, Week 12, and Week 24.
Secondary outcomes (1)
Metabolic Control
glycated hemoglobin (HbA1c)
Measured: All participants will be assessed at baseline, Week 6, Week 12, and Week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start18 Aug 2025
- Primary completion14 Aug 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter randomized controlled trial with two parallel arms: an intervention group and a control group. Participants will be randomly assigned to either group and assessed at baseline (Week 0), Week 6, Week 12, and Week 24. The intervention period lasts 12 weeks, and the Week 24 assessment is a follow-up visit to evaluate the maintenance of intervention effects after completion of the intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yueh chu wu, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255222
- Sponsor's protocol ID
- 2025-A-35
- Status last verified
- Jun 2026
- First submitted
- 25 Sep 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Multimodal Exercise Program on Physical Performance and Muscle Function in Middle-Aged Patients With Type 2 Diabetes: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07255222
- Acronym / sponsor ID
- 2025-A-35
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 14 Aug 2026 (estimated)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 28 Nov 2025 (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.
Background Middle-aged adults with type 2 diabetes mellitus (T2DM), especially in Asian populations, are at increased risk of sarcopenia, reduced muscle function, and decline in physical performance. Effective and feasible exercise interventions are needed to support early prevention and healthy aging.
Methods This is a multicenter randomized controlled trial. The study plans to recruit 66 adults aged 45 to 64 years with a confirmed diagnosis of T2DM. Participants will be randomly assigned to either a control group or an intervention group. The control group will receive a Nutrition and Muscle Health Education Sheet and continue routine health management. The intervention group will receive the same education sheet, a Diabetes and Muscle Health Handbook, and a 12-week multimodal exercise program. From Week 13 to Week 24, app-based maintenance reminders will be provided every two weeks.
All participants will be assessed at baseline (Week 0), Week 6, Week 12, and Week 24. The Week 6 assessment is a mid-intervention assessment, the Week 12 assessment evaluates immediate post-intervention effects, and the Week 24 assessment evaluates sustained effects during the maintenance phase. Assessments include physical performance, muscle function, glycated hemoglobin (HbA1c), health-related quality of life, and the risk of sarcopenia. No additional invasive tests or additional research procedures will be introduced at Week 24.
Outcome Measures The primary outcomes are physical performance and muscle function, including the Short Physical Performance Battery (SPPB), Five-Time Sit-to-Stand Test (5TSTS), handgrip strength, and Skeletal Muscle Index (SMI). Secondary outcomes include HbA1c, health-related quality of life measured by the SF-12, and sarcopenia risk assessed by SARC-CalF.
Expected Outcomes This study aims to provide an evidence-based and feasible multimodal exercise prescription for middle-aged adults with T2DM and to support early intervention strategies for healthy aging.
Detailed description
Primary Outcomes
Physical Function:
Physical performance was assessed using the Short Physical Performance Battery (SPPB), which evaluates lower extremity function through three subtests: balance, gait speed, and chair-stand performance. Each component was scored from 0 to 4, with a total score ranging from 0 to 12, where higher scores indicate better physical performance.
The Five-Times Sit-to-Stand Test (5TSTS) was also used to assess lower limb muscle strength and functional mobility. Participants were instructed to rise from a standard chair (seat height 43-45 cm) to a full standing position and return to sitting five consecutive times as quickly as possible without using their arms. The total time required was recorded in seconds, with longer times indicating poorer performance.
Muscle Strength and Mass:
Handgrip strength was measured using a digital dynamometer (e.g., Jamar or equivalent model) as an indicator of upper limb muscle strength. Participants performed the test in a standing position with the arm fully extended at the side and were instructed to exert maximum force for 3-5 seconds. Two trials were performed for each hand, and the highest value (kg) was used for analysis. Low muscle strength was defined according to the Asian Working Group for Sarcopenia (AWGS 2019) criteria (<28 kg for men and <18 kg for women).
Skeletal Muscle Mass Index (SMI) was determined by bioelectrical impedance analysis (BIA; e.g., InBody 720 or equivalent). Appendicular skeletal muscle mass (ASM, kg) was calculated as the sum of lean mass from both arms and legs. SMI was expressed as ASM divided by height squared (kg/m²). Low muscle mass was defined according to the AWGS 2019 cut-off values (<7.0 kg/m² for men and <5.7 kg/m² for women).
Secondary Outcomes
Metabolic Control:
Glycemic control was evaluated by measuring glycated hemoglobin (HbA1c) levels. Venous blood samples were collected after an overnight fast and analyzed using a standardized high-performance liquid chromatography (HPLC) method. HbA1c values were expressed as percentages according to the National Glycohemoglobin Standardization Program (NGSP) guidelines.
Quality of Life:
Health-related quality of life was assessed using the 12-Item Short Form Health Survey (SF-12). This validated questionnaire consists of 12 items covering eight domains, which are summarized into two composite scores: the Physical Component Summary (PCS) and Mental Component Summary (MCS). Scores were calculated according to the standard scoring manual, with higher scores representing better quality of life.
Sarcopenia Risk Assessment:
Risk of sarcopenia was screened using the SARC-CalF questionnaire, which combines the five-item SARC-F (strength, assistance in walking, rising from a chair, climbing stairs, and falls) with calf circumference measurement. Each item of SARC-F was scored from 0 to 2, yielding a total score ranging from 0 to 10. Calf circumference was measured at the widest point of the right leg using a non-elastic tape, with values ≤34 cm for men and ≤33 cm for women, adding 10 points to the SARC-F score. A total SARC-CalF score ≥11 indicated a high risk of sarcopenia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multicenter randomized controlled trial with two parallel arms: an intervention group and a control group. Participants will be randomly assigned to either group and assessed at baseline (Week 0), Week 6, Week 12, and Week 24. The intervention period lasts 12 weeks, and the Week 24 assessment is a follow-up visit to evaluate the maintenance of intervention effects after completion of the intervention.
| Arm | Type | Receives |
|---|---|---|
| A Multimodal Exercise Intervention | Experimental | Behavioral: A Multimodal Exercise InterventionParticipants in this group will receive a Diabetes and Muscle Health Handbook and participate in a 12-week multimodal exercise program, including supervised instruction, home-based exercise, and digital support. From Week 13 to Week 24, app-based maintenance reminders will be provided every two weeks. |
| control group | No intervention | –Participants in this group will serve as the control for the study. At the beginning of the study, they will only receive a "Nutrition and Muscle Health Education Sheet". They will not participate in the multimodal exercise program and will continue with their usual health management based on existing medical advice. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed with Type 2 Diabetes Mellitus and on stable oral hypoglycemic medication.
- Middle-aged adults between 45 and 64 years old.
- Able to communicate in Mandarin or Taiwanese.
- Willing to provide informed consent or have informed consent obtained from a proxy
Key exclusion criteria (5 listed)
- Limited limb or joint function (e.g., fractures or dislocations).
- Communication or emotional issues, such as depression or mental illness.
- Severe cognitive impairment, such as dementia.
- End-stage renal disease.
- Major comorbidities or complications, including diabetic foot, amputation, myocardial infarction, autonomic neuropathy, and a history of stroke within the last 3 years.
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 Multimodal Exercise InterventionParticipants will receive educational materials and participate in a 12-week multimodal exercise program, followed by app-supported maintenance reminders every two weeks through Week 24. | Behavioural | A Multimodal Exercise Intervention |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: All participants will be assessed at baseline, Week 6, Week 12, and Week 24.
Physical performance was assessed using the Short Physical Performance Battery (SPPB), which evaluates lower extremity function through three subtests: balance, gait speed, and chair-stand performance. Each component was scored from 0 to 4, with a total score ranging from 0 to 12, where higher scores indicate better physical performance.
Five-Times Sit-to-Stand Test (5TSTS)
Time frame: All participants will be assessed at baseline, Week 6, Week 12, and Week 24.
The Five-Times Sit-to-Stand Test (5TSTS) was also used to assess lower limb muscle strength and functional mobility. Participants were instructed to rise from a standard chair (seat height 43-45 cm) to a full standing position and return to sitting five consecutive times as quickly as possible without using their arms. The total time required was recorded in seconds, with longer times indicating poorer performance.
Handgrip strength
Time frame: All participants will be assessed at baseline, Week 6, Week 12, and Week 24.
Handgrip strength was measured using a digital dynamometer (e.g., Jamar or equivalent model) as an indicator of upper limb muscle strength. Participants performed the test in a standing position with the arm fully extended at the side and were instructed to exert maximum force for 3-5 seconds. Two trials were performed for each hand, and the highest value (kg) was used for analysis. Low muscle strength was defined according to the Asian Working Group for Sarcopenia (AWGS 2019) criteria (<28 kg for men and <18 kg for women).
Skeletal Muscle Mass Index (SMI)
Time frame: All participants will be assessed at baseline, Week 6, Week 12, and Week 24.
Skeletal Muscle Mass Index (SMI) was determined by bioelectrical impedance analysis (BIA; e.g., InBody 720 or equivalent). Appendicular skeletal muscle mass (ASM, kg) was calculated as the sum of lean mass from both arms and legs. SMI was expressed as ASM divided by height squared (kg/m²). Low muscle mass was defined according to the AWGS 2019 cut-off values (<7.0 kg/m² for men and <5.7 kg/m² for women).
1 secondary outcome
Metabolic Control
Time frame: All participants will be assessed at baseline, Week 6, Week 12, and Week 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Multimodal Exercise Intervention in people with Type 2 Diabetes Mellitus (T2DM), run by Chung Shan Medical University at 1 site in Taiwan.
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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) (time frame: All participants will be assessed at baseline, Week 6, Week 12, and Week 24.). The study lists 4 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 11 Jun 2026.