Short-Bout Combined Exercise Program
BehavioralA 12-week home-based short-bout combined aerobic and resistance exercise program.
NCT Number: NCT07522359
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.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 12-week home-based short-bout combined aerobic and resistance exercise program.
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.
Time frame: Baseline, 12 weeks, and 24 weeks
Grip strength (kg) measured using a hand grip dynamometer. Higher values indicate greater muscle strength.
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.
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.
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.
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).
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.
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).
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.
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).
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.
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).
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).
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).
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.
Time frame: Baseline, 24 weeks
Cost-utility analysis (CUA) using quality-adjusted life years (QALYs) as the utility outcome.
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.
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).
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.
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).
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).
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.
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.
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).
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).
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).
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).
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).
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).
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).
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).
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).
Contact information is provided by the study sponsor or research team.
Sun Yat-sen University
Other
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
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