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Not yet recruiting NCT07522359

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

No phase Interventional Sarcopenia Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Short-Bout Combined Exercise Program.
Who it may be relevant to
Registry conditions: Sarcopenia, Diabetes. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effect of a Short-Bout Combined Aerobic and Resistance Exercise Program on Physical Activity and Muscle Strength in Older Adults With Diabetes and Probable Sarcopenia: A Randomized Controlled Trial

Overview

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.

Detailed description

The control group will receive usual community-based diabetes care. In addition to usual care, the intervention group will receive an individualized exercise program delivered in a short-bout, high-frequency format (resistance training: 3 days per week, three bouts per day at moderate intensity; aerobic training: 5 days per week, three bouts per day at moderate intensity). Primary outcomes are physical activity level and muscle strength. Assessments will be conducted at baseline, 12 weeks (post-intervention), and 24 weeks (follow-up).

Interventions

  • Behavioral Short-Bout Combined Exercise Program
    A 12-week home-based short-bout combined aerobic and resistance exercise program.

Primary outcome measures

  • Change in Physical Activity Level [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Change in Muscle Strength [Time frame: Baseline, 12 weeks, and 24 weeks]
Secondary outcome measures (12)
  • Change in Appendicular Skeletal Muscle Mass Index [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Change in Skeletal Muscle Mass [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Change in Physical Performance [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Reversal rate of probable sarcopenia [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Change in Glycated Hemoglobin [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Change in Fasting Plasma Glucose [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Change in Sarcopenia Awareness [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Change in Sarcopenia risk [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Change in Nutritional Status [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Change in Frailty Level [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Change in Fall risk [Time frame: Baseline, at 12 weeks post-intervention, and at 24 weeks post-intervention]
  • Change in Depressive Symptoms [Time frame: Baseline, 12 weeks, and 24 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07522359 · L2024SYSU-HL-057 · 2025A1515011403

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗