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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes; Sarcopenia
• Intervention / Treatment: Behavioral: Short-Bout Combined Exercise Program

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).

• Study Type: Interventional
• Enrollment (Estimated): 73
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lu Han, PhD Stud.; Phone Number: +8617539344466; Email: hanlu9@mail2.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short-Bout Combined Aerobic and Resistance Exercise; 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.	Behavioral: Short-Bout Combined Exercise Program; A 12-week home-based short-bout combined aerobic and resistance exercise program.
No Intervention: Usual Community Diabetes Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Lu Han, PhD Stud., Sun Yat-sen University, School of Nursing

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Endocrine System Diseases; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Metabolic Diseases; Glucose Metabolism Disorders; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Diabetes Mellitus; Sarcopenia
• Other Study ID Numbers: L2024SYSU-HL-057; 2025A1515011403 (Other Grant/Funding Number: Guangdong Basic and Applied Basic Research Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No