A Short-Bout Combined Aerobic and Resistance Exercise Program in Older Adults With Diabetes and Probable Sarcopenia

NCT07522359 | Not Yet Recruiting

• 2 other identifiers: L2024SYSU-HL-0572025A1515011403
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

Older adults with diabetes are at high risk of developing sarcopenia. A preclinical stage, known as "probable sarcopenia" (defined by low muscle strength), represents a critical window for early intervention. Physical activity is an effective strategy, but many patients struggle to maintain regular exercise. This parallel-group randomized controlled trial aims to evaluate the effectiveness of a 12-week home-based, short-bout combined aerobic and resistance exercise program on physical activity level and muscle strength among older adults with diabetes and probable sarcopenia.

Conditions

Sarcopenia; Diabetes

Outcome Measures

Primary Outcomes (2)

• Change in Physical Activity Level

  Physical activity level measured using the Physical Activity Scale for the Elderly (PASE). The PASE score ranges from 0 to 400 or more, with higher scores indicating higher levels of physical activity.

  Baseline, 12 weeks, and 24 weeks

• Change in Muscle Strength

  Grip strength (kg) measured using a hand grip dynamometer. Higher values indicate greater muscle strength.

  Baseline, 12 weeks, and 24 weeks

Secondary Outcomes (30)

• Change in Appendicular Skeletal Muscle Mass Index

  Baseline, 12 weeks, and 24 weeks

• Change in Skeletal Muscle Mass

  Baseline, 12 weeks, and 24 weeks

• Change in Physical Performance

  Baseline, 12 weeks, and 24 weeks

• Reversal rate of probable sarcopenia

  Baseline, 12 weeks, and 24 weeks

• Change in Glycated Hemoglobin

  Baseline, 12 weeks, and 24 weeks

Study Arms (2)

Short-Bout Combined Aerobic and Resistance Exercise

EXPERIMENTAL

Participants in the intervention arm will receive a 12-week home-based, short-bout combined aerobic and resistance exercise program in addition to usual community-based diabetes care. The program is designed according to the definition of short-bout accumulated exercise (SBAE), in which exercise is accumulated in multiple bouts of ≤10 minutes each, performed several times per day. Resistance training is performed 3 days per week with 3 bouts per day. Each bout consists of 2 exercises, with each exercise performed as 2 sets of 10 repetitions at moderate intensity. Aerobic training is performed 5 days per week with 3 bouts of 10 minutes each per day at moderate intensity.

Behavioral: Short-Bout Combined Exercise Program

Usual Community Diabetes Care

NO INTERVENTION

Participants receive usual diabetes care as provided in community settings, including routine medical follow-up, standard health education, and diabetes management support from community health centers. No structured exercise program or additional intervention is provided. After the trial, control participants are sent the same exercise program materials as the intervention group, and they can voluntarily choose to access and view them.

Interventions

Short-Bout Combined Exercise Program BEHAVIORAL

A 12-week home-based short-bout combined aerobic and resistance exercise program.

Short-Bout Combined Aerobic and Resistance Exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥60 years, diagnosed with type 2 diabetes mellitus (T2DM) for ≥1 year.
• Meet the Asian Working Group for Sarcopenia (AWGS) 2025 criteria for probable sarcopenia.
• Physical activity \<150 minutes per week of moderate-intensity aerobic activity.
• Conscious, able to communicate effectively in written or spoken language.
• Able to use a smartphone independently (or with minimal assistance).
• Voluntarily participate and provide written informed consent.

You may not qualify if:

• Confirmed sarcopenia based on AWGS 2025.
• History or current diagnosis of psychiatric disorders, or severe cognitive impairment.
• Severe acute or chronic diabetic complications (e.g., diabetic ketoacidosis, proliferative diabetic retinopathy, stage IV-V diabetic nephropathy).
• Severe congestive heart failure (NYHA class III-IV), or acute cardiac event, syncope, or loss of consciousness within the past year.
• Severe pulmonary, hepatic, or renal insufficiency, or active malignancy.
• Concurrent participation in another exercise intervention study.
• Severe joint or muscle disease that strictly limits exercise (e.g., severe osteoarthritis, fracture, or other significant functional impairment), or other absolute contraindications to exercise.
• Unintentional weight change \>5% or major changes in medication regimen within the 3 months prior to enrollment.
• Classified as poor health status (Group 3) according to the Chinese Guideline for the Prevention and Treatment of Type 2 Diabetes in the Elderly (2024 Edition).
• Implanted electronic medical device (e.g., cardiac pacemaker).

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Sarcopenia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Lu Han, PhD Stud.

  Sun Yat-sen University, School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Han, PhD Stud.

CONTACT

+8617539344466; hanlu9@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share