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NCT Number: NCT07522359

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Short-Bout Combined Exercise Program

Behavioral

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

Primary outcomes

  1. Change in Physical Activity Level

    Time frame: Baseline, 12 weeks, and 24 weeks

    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.

  2. Change in Muscle Strength

    Time frame: Baseline, 12 weeks, and 24 weeks

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

Secondary outcomes

  1. Change in Appendicular Skeletal Muscle Mass Index

    Time frame: Baseline, 12 weeks, and 24 weeks

    Appendicular skeletal muscle mass index (kg/m²), calculated as appendicular skeletal muscle mass divided by height squared, assessed using bioelectrical impedance analysis (BIA). Higher values indicate greater relative muscle mass.

  2. Change in Skeletal Muscle Mass

    Time frame: Baseline, 12 weeks, and 24 weeks

    Skeletal muscle mass (kg) assessed by bioelectrical impedance analysis (BIA) using a multi-frequency body composition analyzer. Measurements are performed with participants standing barefoot on the device electrodes. Higher values indicate greater muscle mass.

  3. Change in Physical Performance

    Time frame: Baseline, 12 weeks, and 24 weeks

    Physical Performance measured by the 6-meter walking test. Participants are instructed to walk at their usual pace along a 6-meter course. The time to complete the course is recorded, and gait speed (m/s) is calculated.

  4. Reversal rate of probable sarcopenia

    Time frame: Baseline, 12 weeks, and 24 weeks

    Proportion of participants in the intervention group who reverse from probable sarcopenia to normal status, compared to the control group. Probable sarcopenia is defined according to AWGS 2025 criteria (low handgrip strength).

  5. Change in Glycated Hemoglobin

    Time frame: Baseline, 12 weeks, and 24 weeks

    Glycated hemoglobin (HbA1c) assessed via venous blood sample. Reported as percentage (%), with higher values indicating poorer glycemic control.

  6. Change in Fasting Plasma Glucose

    Time frame: Baseline, 12 weeks, and 24 weeks

    Fasting plasma glucose measured via venous blood sample after at least an 8-hour overnight fast. Reported in millimoles per liter (mmol/L). Higher values indicate poorer glycemic control (a worse outcome).

  7. Change in Sarcopenia Awareness

    Time frame: Baseline, 12 weeks, and 24 weeks

    Sarcopenia awareness measured by the Consequences dimension of the Sarcopenia Awareness Questionnaire (SAQ). One point is awarded for each correct answer identified, with no penalty for incorrect selections. Scores range from 0 to 3, with higher scores indicating greater awareness of sarcopenia consequences (a better outcome). A score of less than 3 indicates insufficient sarcopenia risk awareness.

  8. Change in Sarcopenia risk

    Time frame: Baseline, 12 weeks, and 24 weeks

    Sarcopenia risk assessed by the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire. The SARC-F comprises 5 items, each scored from 0 to 2. Scores range from 0 to 10, with higher scores indicating greater likelihood of sarcopenia (a worse outcome).

  9. Change in Nutritional Status

    Time frame: Baseline, 12 weeks, and 24 weeks

    Nutritional status assessed by the Mini-Nutritional Assessment Short Form (MNA-SF). Scores range from 0 to 14, with higher scores indicating better nutritional status.

  10. Change in Frailty Level

    Time frame: Baseline, 12 weeks, and 24 weeks

    Frailty assessed by the Clinical Frailty Scale (CFS), which ranges from 1 (very fit) to 9 (terminally ill). Higher scores indicate greater frailty (worse outcome).

  11. Change in Fall risk

    Time frame: Baseline, at 12 weeks post-intervention, and at 24 weeks post-intervention

    Fall risk assessed using the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) fall risk self-assessment tool. The STEADI comprises 12 items answered with yes or no. The first 2 items are scored 2 points for a "yes" response and the remaining 10 items are scored 1 point for a "yes" response, with all "no" responses scored 0. Total scores range from 0 to 14, with higher scores indicating greater fall risk (a worse outcome).

  12. Change in Depressive Symptoms

    Time frame: Baseline, 12 weeks, and 24 weeks

    Depressive symptoms assessed by the Patient Health Questionnaire-2 (PHQ-2). The PHQ-2 comprises 2 items, each scored from 0 to 3. Scores range from 0 to 6, with higher scores indicating greater severity of depressive symptoms (a worse outcome).

  13. Number of Adverse Events

    Time frame: Throughout the study (Baseline to 24 weeks)

    Number of adverse events occurring during the study period, including falls, unplanned hospital admissions, severe hypoglycemic events, and fracture events.

  14. Cost-Utility Analysis Indicators

    Time frame: Baseline, 24 weeks

    Cost-utility analysis (CUA) using quality-adjusted life years (QALYs) as the utility outcome.

  15. Process Evaluation Indicators

    Time frame: Throughout the study (Baseline to 24 weeks)

    Process Evaluation Indicators include Fidelity, Dose, Reach (Recruitment Rate, Retention Rate), Adaptations, Adherence, Exploratory Mechanism Analysis (Participant Responses, Mediators, Unexpected Pathways), Context Factors, and Qualitative Interviews.

  16. Change in Total Body Water

    Time frame: Baseline, 12 weeks, and 24 weeks

    Total body water assessed by bioelectrical impedance analysis (BIA) using a multi-frequency body composition analyzer. Measurements are performed with participants standing barefoot on the device electrodes. Reported in liters (L).

  17. Change in Inorganic Salt Mass

    Time frame: Baseline, 12 weeks, and 24 weeks

    Inorganic salt mass assessed by bioelectrical impedance analysis (BIA) using a multi-frequency body composition analyzer. Measurements are performed with participants standing barefoot on the device electrodes. Reported in kilograms (kg). Higher values indicate greater mineral content.

  18. Change in Fat Mass

    Time frame: Baseline, 12 weeks, and 24 weeks

    Fat mass assessed by bioelectrical impedance analysis (BIA) using a multi-frequency body composition analyzer. Measurements are performed with participants standing barefoot on the device electrodes. Reported in kilograms (kg). Higher values indicate greater body fat mass (a worse outcome).

  19. Yubi-wakka Test

    Time frame: Baseline, 12 weeks, and 24 weeks

    Sarcopenia screening assessed using the Yubi-wakka (finger-ring) test. Participants form a ring with the thumbs and index fingers of both hands and encircle the thickest part of their non-dominant calf. Results are classified into three categories: "bigger" (calf circumference larger than finger-ring, lowest risk), "just fits" (calf circumference equal to finger-ring, intermediate risk), or "smaller" (calf circumference smaller than finger-ring, highest risk). A "smaller" result indicates the greatest risk of sarcopenia (a worse outcome).

  20. Body Fat Percentage

    Time frame: Baseline, 12 weeks, and 24 weeks

    Body fat percentage assessed by bioelectrical impedance analysis (BIA) using a multi-frequency body composition analyzer. Measurements are performed with participants standing barefoot on the device electrodes. Reported as a percentage (%). Higher values indicate greater body fat accumulation.

  21. Change in Protein Mass

    Time frame: Baseline, 12 weeks, and 24 weeks

    Protein mass assessed by bioelectrical impedance analysis (BIA) using a multi-frequency body composition analyzer. Measurements are performed with participants standing barefoot on the device electrodes. Reported in kilograms (kg). Higher values indicate greater body protein mass.

  22. Change in EuroQol-5D-5L Scores

    Time frame: Baseline, 12 weeks, and 24 weeks

    EuroQol-5D-5L (EQ-5D-5L) includes five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each rated from 1 to 5, and a visual analogue scale (VAS) from 0 (worst health) to 100 (best health).

  23. Change in Affective Attitude toward Physical Activity

    Time frame: Baseline, 12 weeks, and 24 weeks

    Affective attitude toward physical activity assessed using the Affective Attitude subscale of the Multi-Process Action Control (M-PAC) framework questionnaire. The subscale comprises 3 items rated on a 7-point Likert scale. Scores range from 3 to 21, with higher scores indicating more positive affective attitudes toward physical activity (a better outcome).

  24. Change in Instrumental Attitude toward Physical Activity

    Time frame: Baseline, 12 weeks, and 24 weeks

    Instrumental attitude toward physical activity assessed using the Instrumental Attitude subscale of the Multi-Process Action Control (M-PAC) framework questionnaire. The subscale comprises 3 items rated on a 7-point Likert scale. Scores range from 3 to 21, with higher scores indicating more positive instrumental attitudes toward physical activity (a better outcome).

  25. Change in Perceived Capability for Physical Activity

    Time frame: Baseline, 12 weeks, and 24 weeks

    Perceived capability to engage in regular physical activity assessed using the Perceived Capability subscale of the Multi-Process Action Control (M-PAC) framework questionnaire. The subscale comprises 3 items rated on a 5-point Likert scale. Scores range from 3 to 15, with higher scores indicating greater perceived capability for physical activity (a better outcome).

  26. Change in Perceived Opportunity for Physical Activity

    Time frame: Baseline, 12 weeks, and 24 weeks

    Perceived opportunity for physical activity assessed using the Perceived Capability subscale of the Multi-Process Action Control (M-PAC) framework questionnaire. The subscale comprises 3 items rated on a 5-point Likert scale. Scores range from 3 to 15, with higher scores indicating greater perceived opportunity for physical activity (a better outcome).

  27. Change in Intention to Engage in Physical Activity

    Time frame: Baseline, 12 weeks, and 24 weeks

    Intention to engage in physical activity assessed using a single-item measure of the Multi-Process Action Control (M-PAC) framework questionnaire. Participants report the number of sessions per week they intend to engage in physical activity. As an open-ended item, there is no fixed maximum score, with higher values indicating greater intention to engage in physical activity (a better outcome).

  28. Change in Physical Activity Regulation Behaviours

    Time frame: Baseline, 12 weeks, and 24 weeks

    Physical activity regulation behaviours assessed using a 6-item scale, which forms part of the Multi-Process Action Control (M-PAC) framework questionnaire. Participants rate their agreement with six statements about self-regulatory behaviours on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Scores range from 6 to 30, with higher scores indicating greater use of self-regulatory strategies to maintain physical activity (a better outcome).

  29. Change in Physical Activity Habit

    Time frame: Baseline, 12 weeks, and 24 weeks

    Physical activity habit assessed using the Self-Report Behavioural Automaticity Index (SRBAI), a 4-item subscale of the Self-Report Habit Index. Participants rate their agreement with four statements about the automaticity of physical activity behaviours on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Scores range from 4 to 20, with higher scores indicating greater automaticity of physical activity behaviour (a better outcome).

  30. Change in Physical Activity Identity

    Time frame: Baseline, 12 weeks, and 24 weeks

    Physical activity identity assessed using the Exercise Identity Scale (EIS). Participants rate their agreement with four statements regarding physical activity identity on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Scores range from 4 to 20, with higher scores indicating stronger identification with being a physically active person (a better outcome).

Study contacts

Contact information is provided by the study sponsor or research team.

Lu Han, PhD Stud.

CONTACT

[email protected]

+8617539344466

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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