Diabetes, Sarcopenia
Conditions
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.
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
BEHAVIORALShort-Bout Combined Exercise Program
A 12-week home-based short-bout combined aerobic and resistance exercise program.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Activity Level | 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. |
| Change in Muscle Strength | Baseline, 12 weeks, and 24 weeks | Grip strength (kg) measured using a hand grip dynamometer. Higher values indicate greater muscle strength. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Appendicular Skeletal Muscle Mass Index | 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. |
| Change in Skeletal Muscle Mass | 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. |
| Change in Physical Performance | 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. |
| Reversal rate of probable sarcopenia | 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). |
| Change in Glycated Hemoglobin | Baseline, 12 weeks, and 24 weeks | Glycated hemoglobin (HbA1c) assessed via venous blood sample. Reported as percentage (%), with higher values indicating poorer glycemic control. |
| Change in Fasting Plasma Glucose | 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). |
| Change in Sarcopenia Awareness | 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. |
| Change in Sarcopenia risk | 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). |
| Change in Nutritional Status | 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. |
| Change in Frailty Level | 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). |
| Change in Fall risk | 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). |
| Change in Depressive Symptoms | 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). |
| Number of Adverse Events | 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. |
| Cost-Utility Analysis Indicators | Baseline, 24 weeks | Cost-utility analysis (CUA) using quality-adjusted life years (QALYs) as the utility outcome. |
| Process Evaluation Indicators | 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. |
| Change in Total Body Water | 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). |
| Change in Inorganic Salt Mass | 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. |
| Change in Fat Mass | 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). |
| Yubi-wakka Test | 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). |
| Body Fat Percentage | 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. |
| Change in Protein Mass | 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. |
| Change in EuroQol-5D-5L Scores | 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). |
| Change in Affective Attitude toward Physical Activity | 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). |
| Change in Instrumental Attitude toward Physical Activity | 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). |
| Change in Perceived Capability for Physical Activity | 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). |
| Change in Perceived Opportunity for Physical Activity | 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). |
| Change in Intention to Engage in Physical Activity | 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). |
| Change in Physical Activity Regulation Behaviours | 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). |
| Change in Physical Activity Habit | 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). |
| Change in Physical Activity Identity | 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). |
Contacts
CONTACTLu Han, PhD Stud.
PRINCIPAL_INVESTIGATORLu Han, PhD Stud.
Sun Yat-sen University, School of Nursing
Outcome results
None listed