SarcopeniaBCW-RESNCT07601321
BCW-Based Resistance Training for Community-Dwelling Sarcopenia Patients
A study testing BCW-Based Resistance Exercise Program in people with Sarcopenia, run by Hangzhou Normal University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- BCW-Based Resistance Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Tianshui Wulin Sub-district Community Health Service Center
Hangzhou, Zhejiang
About this study
Official title: Effects of a Behavior Change Wheel (BCW)-Based Resistance Exercise Program on Community-Dwelling Patients With Sarcopenia: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- BCW-Based Resistance Exercise Program
- Keywords
- Sarcopenia, Resistance Exercise, Behavior Change Wheel
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCW-Based Resistance Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training Group | Experimental | Participants in this group will receive the BCW-based resistance exercise program immediately for 12 weeks (twice weekly). Receives: Behavioral: BCW-Based Resistance Exercise Program |
| Waitlist Control Group | No intervention | Participants will maintain their usual routine for the first 3 months. After the primary endpoint assessment at month 3, they will cross over to receive the identical 12-week resistance exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Mass Index
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).
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (6)
Handgrip Strength
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.
Measured: Baseline, Month 3, and Month 6
6-Meter Gait Speed
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.
Measured: Baseline, Month 3, and Month 6
Self-Efficacy for Exercise Scale - Chinese Version (SEE-C) Score
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.
Measured: Baseline, Month 3, and Month 6
Exercise Adherence Rate
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.
Measured: Month 3 (Experimental Group) and Month 6 (Waitlist Group)
Sarcopenia Quality of Life (SarQoL) Questionnaire Score
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.
Measured: Baseline, Month 3, and Month 6
Participant satisfaction
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.
Measured: Month 3 (Experimental Group) and Month 6 (Waitlist Group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: The study was withdrawn before enrollment because the planned community health service center did not approve the implementation of the intervention, and no participants had been recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bofeng Ye, Hangzhou Normal University
- Investigators
- Xuejiao Zhu, PhD, Principal investigator, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601321
- Sponsor's protocol ID
- 2026017
- Other IDs
- YJSYC202603152
- Acronym
- BCW-RES
- Status last verified
- Jul 2026
- First submitted
- 15 May 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Behavior Change Wheel (BCW)-Based Resistance Exercise Program on Community-Dwelling Patients With Sarcopenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07601321
- Acronym / sponsor ID
- BCW-RES / 2026017
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Resistance Exercise, Behavior Change Wheel
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn before enrollment because the planned community health service center did not approve the implementation of the intervention, and no participants had been recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Resistance Training Group | Experimental | Behavioral: BCW-Based Resistance Exercise ProgramParticipants in this group will receive the BCW-based resistance exercise program immediately for 12 weeks (twice weekly). |
| Waitlist Control Group | No intervention | –Participants will maintain their usual routine for the first 3 months. After the primary endpoint assessment at month 3, they will cross over to receive the identical 12-week resistance exercise program. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCW-Based Resistance Exercise ProgramStructured 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. | Behavioural | Resistance Training Group |
Primary outcome
Skeletal Muscle Mass Index
Time frame: 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).
6 secondary outcomes
Handgrip Strength
Time frame: Baseline, Month 3, and Month 6
6-Meter Gait Speed
Time frame: Baseline, Month 3, and Month 6
Self-Efficacy for Exercise Scale - Chinese Version (SEE-C) Score
Time frame: Baseline, Month 3, and Month 6
Exercise Adherence Rate
Time frame: Month 3 (Experimental Group) and Month 6 (Waitlist Group)
Sarcopenia Quality of Life (SarQoL) Questionnaire Score
Time frame: Baseline, Month 3, and Month 6
Participant satisfaction
Time frame: Month 3 (Experimental Group) and Month 6 (Waitlist Group)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuejiao Zhu, PhD principal investigator
Hangzhou Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCW-Based Resistance Exercise Program in people with Sarcopenia, run by Hangzhou Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal Muscle Mass Index (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.