Multimodal Training Effects in Middle-Aged and Older Adults With Diabetic Sarcopenia

NCT07398495 | Recruiting

• 1 other identifier: CSH-2026-A-036
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effects of a 12-week multimodal exercise intervention on middle-aged and older adults (aged 45\~85 years) with Type 2 Diabetes Mellitus (T2DM). The program combines supervised training, home-based sessions, and digital support to improve muscle function, physical performance, metabolic control, and quality of life.

Conditions

Type 2 Diabetes Mellitus (T2DM); Sarcopenia

Outcome Measures

Primary Outcomes (4)

• Physical Function (5TSTS)

  The Five-Times Sit-to-Stand Test (5TSTS) assesses lower limb muscle power. Participants are asked to stand up and sit down five times as quickly as possible with arms folded. The time to completion is recorded in seconds and analyzed as a continuous variable. According to the 2019 Asian Working Group for Sarcopenia (AWGS) consensus, a completion time of ≥ 12 seconds is considered abnormal and indicates low physical performance.

  Change from Baseline at Week 12 and Week 24

• Handgrip Strength (HGS)

  Handgrip strength (HGS) is assessed using a digital dynamometer (e.g., Jamar or an equivalent device). During the assessment, participants stand with their testing arm fully extended. Two consecutive trials are performed for each hand, and the maximum grip strength value (in kilograms) is selected for data analysis. Based on the 2019 Asian Working Group for Sarcopenia (AWGS) consensus, low muscle strength is defined as \< 28 kg for men and \< 18 kg for women

  Change from Baseline at Week 12 and Week 24

• Skeletal Muscle Mass Index (SMI)

  Determined by bioelectrical impedance analysis (BIA). Appendicular skeletal muscle mass (ASM, kg) is calculated as the sum of lean mass from both arms and legs. SMI is expressed as ASM divided by height squared (kg/m²). Low muscle mass is defined according to AWGS 2019 cut-off values (\<7.0 kg/m² for men and \<5.7 kg/m² for women).

  Change from Baseline at Week 12 and Week 24

• Sarcopenia Risk: Assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire combined with calf circumference measurement (SARC-CalF).

  Assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire combined with calf circumference measurement (SARC-CalF). The SARC-F assesses 5 items scored 0-10. A calf circumference ≤34 cm (men) or ≤33 cm (women) adds 10 points. Total SARC-CalF scores range from 0 to 20. Higher scores indicate a higher risk of sarcopenia (a worse outcome). A total SARC-CalF score ≥11 indicates a high risk.

  Change from Baseline at Week 12 and Week 24

Secondary Outcomes (2)

• Glycated Hemoglobin (HbA1c)

  Change from Baseline at Week 12 and Week 24

• Quality of Life (SF-12)

  Change from Baseline at Week 12 and Week 24

Study Arms (2)

Intervention Group (Multimodal Exercise)

EXPERIMENTAL

• Arm Description: Participants in this group will engage in a 12-week multimodal exercise program. The program includes supervised training sessions, home-based exercises, and digital support. They will also receive a "Diabetes and Muscle Health Handbook" to guide their training.

Behavioral: Multimodal Exercise Program

Control Group (Standard Care)

NO INTERVENTION

Participants in this group will serve as the control. They will receive a "Nutrition and Muscle Health Education Sheet" at the beginning of the study. They will not participate in the multimodal exercise program and will continue with their routine health management based on existing medical advice.

Interventions

Multimodal Exercise Program BEHAVIORAL

Participants will engage in a 12-week multimodal exercise program comprising supervised training sessions, home-based exercises, and digital support. To facilitate adherence and proper technique, participants will also receive a "Diabetes and Muscle Health Handbook" as a training guide.

Also known as: Control Group

Intervention Group (Multimodal Exercise)

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with both Type 2 Diabetes Mellitus (T2DM) and sarcopenia.
• Maintained on a stable regimen of oral hypoglycemic agents.
• Aged 45 years or older.
• Capable of communicating effectively in Mandarin or Taiwanese.
• Willing to provide informed consent or have it obtained from a legally authorized representative.

You may not qualify if:

• Limited limb or joint function that prevents exercise (e.g., recent fractures or dislocations).
• Communication barriers or severe emotional/psychological issues (e.g., uncontrolled depression or severe mental illness).
• Severe cognitive impairment (e.g., dementia).
• End-stage renal disease (ESRD).
• Major comorbidities or complications, including active diabetic foot ulcers, amputation, recent myocardial infarction, severe autonomic neuropathy, or a history of stroke within the last 3 years.

Sponsors & Collaborators

• yueh chu wu: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan, 402306, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sarcopenia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

yueh chu wu WU YUEH CHU

CONTACT

886-952680613; yueh.chu46240@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 10, 2026
• Study Start: February 23, 2026
• Primary Completion: May 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)