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

NCT07255222 | Active Not Recruiting

• 1 other identifier: 2025-A-35
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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).

  All participants will be assessed at baseline, Week 6, Week 12, and Week 24.

Secondary Outcomes (1)

• Metabolic Control

  All participants will be assessed at baseline, Week 6, Week 12, and Week 24.

Other Outcomes (2)

• 12-Item Short Form Health Survey (SF-12)

  All participants will be assessed at baseline, Week 6, Week 12, and Week 24.

• Sarcopenia Risk Assessment

  All participants will be assessed at baseline, Week 6, Week 12, and Week 24.

Study Arms (2)

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.

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.

Interventions

A Multimodal Exercise Intervention BEHAVIORAL

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.

A Multimodal Exercise Intervention

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 402306, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be blinded to group allocation when performing outcome assessments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Diabetes Educator

Model Details: 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.

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: November 28, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)