Sarcopenia
Conditions
Keywords
Sarcopenia, Resistance Exercise, Behavior Change Wheel
Brief summary
The purpose of this randomized controlled trial is to evaluate the effects of a Behavior Change Wheel (BCW)-based resistance exercise program on muscle health, physical performance, and exercise adherence in community-dwelling older adults with sarcopenia. Participants will be randomly assigned to either an experimental group or a waitlist control group. The experimental group will receive a 12-week BCW-based resistance exercise intervention (twice a week) immediately. The waitlist control group will maintain their usual routine for the first 3 months for comparison, and will then cross over to receive the identical 12-week intervention. The study aims to provide an effective and ethical exercise management strategy for sarcopenic patients.
Detailed description
Sarcopenia is a progressive and generalized skeletal muscle disorder that significantly impairs physical function and quality of life in older adults. While resistance exercise is a well-established countermeasure, poor long-term exercise adherence remains a critical clinical barrier. To address this, the current study utilizes the Behavior Change Wheel (BCW) theory to construct a structured, theory-driven resistance exercise program aimed at enhancing both physiological health and behavioral compliance. This study employs a randomized, waitlist-controlled trial design to ensure ethical equity, allowing all participants to eventually benefit from the intervention. Eligible community-dwelling older adults with sarcopenia will be randomly assigned to either an experimental group or a waitlist control group. The experimental group will immediately commence a 12-week BCW-based resistance exercise intervention (conducted twice weekly). The waitlist control group will undergo a 3-month observation period with their usual routine, after which they will cross over to receive the identical 12-week exercise program. To comprehensively evaluate the efficacy of the intervention, primary and secondary outcomes-encompassing structural muscle health, physical performance, psychological indicators (e.g., self-efficacy, quality of life), and patient satisfaction-will be rigorously assessed at baseline, at 3 months, and post-intervention.
Interventions
BEHAVIORALBCW-Based Resistance Exercise Program
Structured 12-week resistance exercise (RE) program based on the Behavior Change Wheel (BCW) and COM-B model. Theory (BCW): Capability is enhanced via sarcopenia education and face-to-face instruction. Opportunity is facilitated by providing free resistance bands, training venues, and peer demonstrations. Motivation is sustained via a points-based reward system, social commendations, and phone/alarm reminders. Protocol (FITT): Frequency: 2 supervised sessions/week (\>=48h apart). Time: 60-min sessions (meditation, warm-up, RE, stretching). Intensity: Progressive loading from 40%-50% up to 70% of 1RM using color-coded bands. Progressions (+5% 1RM) guided by Borg RPE (12-14). Type: Multi-component RE (chest, back, shoulders, glutes, lower body, core) doing 1-2 sets of 10 reps with 60-90s rest. Safety: Vitals (BP, HR) are recorded pre- and post-session. Continuous symptom monitoring prevents adverse events. No fasting exercise permitted.
Sponsors
Hangzhou Normal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors for physiological outcomes and questionnaires are blinded to group allocation.
Intervention model description
This study employs a randomized, waitlist-controlled parallel design conducted in two stages. Phase 1 (Months 0-3) is a parallel-group comparison where the experimental group receives a 12-week BCW-based intervention while the control group maintains usual routine. In Phase 2 (Months 3-6), the waitlist group crosses over to receive the identical 12-week intervention. This model facilitates both between-group efficacy analysis at the 3-month primary endpoint and longitudinal self-controlled (pre-post) analysis for participants in both arms.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Meet the diagnostic criteria for sarcopenia according to the Asian Working Group for Sarcopenia (AWGS) 2025: Low muscle mass (SMI measured by BIA): For age ≥ 65, Male \< 7.0 kg/m², Female \< 5.7 kg/m²; For age 50-64, Male \< 7.6 kg/m², Female \< 5.7 kg/m². Low muscle strength (Handgrip strength): For age ≥ 65, Male \< 28 kg, Female \< 18 kg; For age 50-64, Male \< 34 kg, Female \< 20 kg. Ability to walk independently without assistive devices. Clear consciousness and stable medical condition. Willingness to participate, commit to the exercise protocol, and provide signed informed consent. Proficiency in using a smartphone.
Exclusion criteria
* Presence of metal implants, such as cardiac pacemakers, stents, steel plates, or artificial joints (due to BIA measurement constraints). Cognitive impairment, epilepsy, other neurological disorders, or severe mental illness that prevents cooperation with the study. Inability to complete the exercise intervention due to severe cardiovascular or musculoskeletal diseases. Severe organ dysfunction (e.g., heart failure), organ failure, or active infection. Inability to maintain adherence or significant missing data (participants who withdraw or are lost to follow-up).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal Muscle Mass Index | Baseline, 3 months, and 6 months | Skeletal muscle mass will be measured using Bioelectrical Impedance Analysis (BIA). SMI is calculated as appendicular skeletal muscle mass (ASM) divided by height squared (kg/m²). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip Strength | Baseline, Month 3, and Month 6 | Measured in kilograms (kg) using an electronic handgrip dynamometer. Participants stand with arms hanging naturally and squeeze the device with their dominant hand with maximum effort. The test is performed twice with a 1-minute interval, and the maximum value is recorded. |
| 6-Meter Gait Speed | Baseline, Month 3, and Month 6 | Calculated in meters per second (m/s). Participants walk at a usual pace over a 6-meter distance. The test is conducted at least twice, and the average value is used to evaluate physical performance. |
| Self-Efficacy for Exercise Scale - Chinese Version (SEE-C) Score | Baseline, Month 3, and Month 6 | Assessed using the 9-item Chinese version of the SEE scale. Each item is rated from 0 (no confidence) to 10 (total confidence). The total score is the sum of all items divided by 9. Higher scores indicate higher exercise self-efficacy. |
| Exercise Adherence Rate | Month 3 (Experimental Group) and Month 6 (Waitlist Group) | Expressed as the ratio of actual exercise sessions attended to the planned sessions. Good adherence is defined as completing 80% or more of the scheduled sessions over the 12-week intervention period. |
| Sarcopenia Quality of Life (SarQoL) Questionnaire Score | Baseline, Month 3, and Month 6 | Assessed using the Chinese(Mandarin) version of the Sarcopenia Quality of Life (SarQoL) questionnaire. It specifically evaluates the quality of life in older adults with sarcopenia across multiple domains. Scores range from 0 to 100, with higher scores representing better quality of life. |
| Participant satisfaction | Month 3 (Experimental Group) and Month 6 (Waitlist Group) | The questionnaire will cover four domains, including satisfaction with the exercise program, instructor support, facility conditions, and overall perceived benefit. Each item will be rated on a 5-point Likert scale (1 = very dissatisfied to 5 = very satisfied), and the mean score will be calculated, with higher scores indicating greater satisfaction. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXuejiao Zhu, PhD
Hangzhou Normal University
Outcome results
None listed