RecruitingNot ApplicableNCT07255222

Effects of a Multimodal Exercise Program on Physical Performance and Muscle Function in Middle-aged Patients With T2DM

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


Sponsor

yueh chu wu

Enrollment

66 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Background Middle-aged individuals with T2DM, especially in Asian populations, face a heightened risk of sarcopenia. This condition leads to a decline in muscle mass and function, which negatively impacts their quality of life. Effective interventions are therefore urgently needed to slow the progression of the disease and mitigate these risks. Methods * Study Design: This is a multicenter randomized controlled trial. * Participants: The study plans to recruit 66 adults, aged 45 to 64, with a confirmed diagnosis of T2DM. * Group Assignment: Participants will be randomly assigned to either a control group or an intervention group. * Control Group: Participants will receive only a "Nutrition and Muscle Health Education Sheet" and continue with their routine health management based on existing medical advice. * Intervention Group: Participants will receive the same leaflet along with a "Diabetes and Muscle Health Handbook" and will take part in a 12-week multimodal exercise program. * Assessments: All participants will be assessed at baseline, week 6, and week 12. Outcome Measures * Primary Outcomes: o Physical Function: Short Physical Performance Battery (SPPB), Five-Times Sit-to-Stand Test (5TSTS), handgrip strength, and Skeletal Muscle Mass Index (SMI). * Secondary Outcomes: * Metabolic Control: Glycated hemoglobin (HbA1c). * Quality of Life: SF-12 Quality of Life questionnaire. * Sarcopenia Risk: Evaluated by the SARC-CalF questionnaire. Expected Outcomes This study aims to provide an evidence-based and feasible multimodal exercise prescription for middle-aged adults with T2DM. The findings are expected to support early intervention strategies for healthy aging and serve as a valuable reference for clinical practice and the development of public health policies.


Eligibility

Min Age: 45 YearsMax Age: 64 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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.

Interventions

BEHAVIORALA Multimodal Exercise Intervention

Participants will receive the same leaflet along with a "Diabetes and Muscle Health Handbook" and will take part in a 12-week multimodal exercise program.


Locations(1)

Chung Shan Medical University Hospital

Taichung, Taiwan

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NCT07255222


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