Actively Recruiting

Phase Not Applicable
Age: 45Years - 64Years
All Genders
NCT07255222

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

Led by yueh chu wu · Updated on 2025-11-28

66

Participants Needed

1

Research Sites

19 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Limited limb or joint function such as fractures or dislocations.
  • Communication or emotional issues like 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 history of stroke within the last 3 years.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chung Shan Medical University Hospital

Taichung, Taiwan, 402306

Actively Recruiting

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Research Team

Y

yueh chu WU YUEH CHU

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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