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| ID | Type | Description | Link |
|---|---|---|---|
| 2025A1515011403 | Other Grant/Funding Number | Guangdong Basic and Applied Basic Research Foundation |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short-Bout Combined Exercise Program | Behavioral | A 12-week home-based short-bout combined aerobic and resistance exercise program. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 12 weeks, and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Han, PhD Stud. | Contact | +8617539344466 | hanlu9@mail2.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lu Han, PhD Stud. | Sun Yat-sen University, School of Nursing | Principal Investigator |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 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. |
| Baseline, 12 weeks, and 24 weeks |
| 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. | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| Change in Glycated Hemoglobin | Glycated hemoglobin (HbA1c) assessed via venous blood sample. Reported as percentage (%), with higher values indicating poorer glycemic control. | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| 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. | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| 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. | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, at 12 weeks post-intervention, and at 24 weeks post-intervention |
| 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). | Baseline, 12 weeks, and 24 weeks |
| Number of Adverse Events | Number of adverse events occurring during the study period, including falls, unplanned hospital admissions, severe hypoglycemic events, and fracture events. | Throughout the study (Baseline to 24 weeks) |
| Cost-Utility Analysis Indicators | Cost-utility analysis (CUA) using quality-adjusted life years (QALYs) as the utility outcome. | Baseline, 24 weeks |
| 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. | Throughout the study (Baseline to 24 weeks) |
| 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). | Baseline, 12 weeks, and 24 weeks |
| 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. | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| 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. | Baseline, 12 weeks, and 24 weeks |
| 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. | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |