12-week multimodal exercise program to improve muscle strength and physical performance in middle-aged people with type 2 diabetes
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
This 12-week program tests whether a combined exercise and educational plan helps 45–64-year-olds with type 2 diabetes improve muscle strength, muscle mass, and physical function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 45 Years to 64 Years |
| Sex | All |
| Sponsor | Chung Shan Medical University Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT07255222 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial will enroll 66 adults aged 45–64 with diagnosed type 2 diabetes and randomize them to a control group receiving a nutrition and muscle-health education sheet or an intervention group receiving the same leaflet plus a handbook and a 12-week multimodal exercise program. Primary outcomes include physical performance measured by the Short Physical Performance Battery and Five-Times Sit-to-Stand, as well as muscle strength (handgrip) and skeletal muscle mass index measured by bioelectrical impedance analysis. Eligible participants must be on stable oral hypoglycemic medication and able to communicate in Mandarin or Taiwanese, while people with major comorbidities, severe cognitive impairment, or significant limb/joint limitations are excluded. The trial is led from Chung Shan Medical University Hospital in Taichung and compares usual education alone versus education plus structured exercise.
Who should consider this trial
Good fit: Adults aged 45–64 with diagnosed type 2 diabetes on stable oral hypoglycemic medication who can communicate in Mandarin or Taiwanese and are physically able to exercise are ideal candidates.
Not a fit: Patients with end-stage renal disease, recent major cardiovascular or cerebrovascular events, diabetic foot or amputation, severe cognitive or communication impairments, or major limb/joint limitations are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could slow sarcopenia-related decline and improve mobility, strength, and quality of life for middle-aged people with type 2 diabetes.
How similar studies have performed: Prior exercise-based interventions in people with type 2 diabetes and older adults have demonstrated improvements in muscle strength and function, so this approach builds on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Taichung
- Chung Shan Medical University Hospital — Taichung, Taiwan (Recruiting)
Study contacts
- Study coordinator: yueh chu WU YUEH CHU
- Email: yueh.chu46240@gmail.com
- Phone: 886-952680613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.