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SarcopeniaNCT07522359

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

A study testing Short-Bout Combined Exercise Program in people with Sarcopenia and Diabetes, run by Sun Yat-sen University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Sarcopenia, Diabetes
What is being tested?
Short-Bout Combined Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
No sites listed yet
Study dates
1 Apr 2026to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

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

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.

Read the 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).

Conditions
Sarcopenia, Diabetes
Being tested
Short-Bout Combined Exercise Program
Medical subject headings
Sarcopenia, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Short-Bout Combined Exercise ProgramBehavioural

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

Study groups in NCT07522359
Study groupRoleWhat they receive
Short-Bout Combined Aerobic and Resistance ExerciseExperimentalParticipants 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.
Receives: Behavioral: Short-Bout Combined Exercise Program
Usual Community Diabetes CareNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 12 weeks, and 24 weeks

  2. Change in Muscle Strength

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

    Measured: Baseline, 12 weeks, and 24 weeks

Secondary outcomes (30)
  1. Change in Appendicular Skeletal Muscle Mass Index

    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.

    Measured: Baseline, 12 weeks, and 24 weeks

  2. Change in Skeletal Muscle Mass

    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.

    Measured: Baseline, 12 weeks, and 24 weeks

  3. Change in Physical Performance

    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.

    Measured: Baseline, 12 weeks, and 24 weeks

  4. Reversal rate of probable sarcopenia

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  5. Change in Glycated Hemoglobin

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

    Measured: Baseline, 12 weeks, and 24 weeks

  6. Change in Fasting Plasma Glucose

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  7. Change in Sarcopenia Awareness

    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.

    Measured: Baseline, 12 weeks, and 24 weeks

  8. Change in Sarcopenia risk

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  9. Change in Nutritional Status

    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.

    Measured: Baseline, 12 weeks, and 24 weeks

  10. Change in Frailty Level

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  11. Change in Fall risk

    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).

    Measured: Baseline, at 12 weeks post-intervention, and at 24 weeks post-intervention

  12. Change in Depressive Symptoms

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  13. Number of Adverse Events

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

    Measured: Throughout the study (Baseline to 24 weeks)

  14. Cost-Utility Analysis Indicators

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

    Measured: Baseline, 24 weeks

  15. Process Evaluation Indicators

    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.

    Measured: Throughout the study (Baseline to 24 weeks)

  16. Change in Total Body Water

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  17. Change in Inorganic Salt Mass

    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.

    Measured: Baseline, 12 weeks, and 24 weeks

  18. Change in Fat Mass

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  19. Yubi-wakka Test

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  20. Body Fat Percentage

    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.

    Measured: Baseline, 12 weeks, and 24 weeks

  21. Change in Protein Mass

    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.

    Measured: Baseline, 12 weeks, and 24 weeks

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

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  23. Change in Affective Attitude toward Physical Activity

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  24. Change in Instrumental Attitude toward Physical Activity

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  25. Change in Perceived Capability for Physical Activity

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  26. Change in Perceived Opportunity for Physical Activity

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  27. Change in Intention to Engage in Physical Activity

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  28. Change in Physical Activity Regulation Behaviours

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  29. Change in Physical Activity Habit

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

  30. Change in Physical Activity Identity

    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).

    Measured: Baseline, 12 weeks, and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
73 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07522359
Sponsor's protocol ID
L2024SYSU-HL-057
Other IDs
2025A1515011403
Status last verified
Apr 2026
First submitted
27 Mar 2026
Last updated
13 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Short-Bout Combined Exercise Program in people with Sarcopenia and Diabetes, run by Sun Yat-sen University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lu Han, PhD Stud. (+8617539344466, hanlu9@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Physical Activity Level (time frame: Baseline, 12 weeks, and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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