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WithdrawnNCT07601321BCW-RESUpdated Jul 9, 2026

BCW-Based Resistance Training for Community-Dwelling Sarcopenia Patients

An interventional study of BCW-Based Resistance Exercise Program in Sarcopenia, sponsored by Hangzhou Normal University. Withdrawn at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Hangzhou Normal University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
The study was withdrawn before enrollment because the planned community health service center did not approve the implementation of the intervention, and no participants had been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.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Sarcopenia

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Keywords

  • Sarcopenia
  • Resistance Exercise
  • Behavior Change Wheel
03

In context

Sarcopenia

1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.

Browse Sarcopenia studies →

Lead sponsor

Hangzhou Normal University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Proficiency in using a smartphone.

Exclusion criteria

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).

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Resistance Training Group

    Participants in this group will receive the BCW-based resistance exercise program immediately for 12 weeks (twice weekly).

    Behavioral: BCW-Based Resistance Exercise Program

  • No intervention
    Waitlist Control Group

    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.

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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline, 3 months, and 6 months

Secondary outcomes

  1. 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.

    Time frame: Baseline, Month 3, and Month 6

  2. 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.

    Time frame: Baseline, Month 3, and Month 6

  3. 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.

    Time frame: Baseline, Month 3, and Month 6

  4. 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.

    Time frame: Month 3 (Experimental Group) and Month 6 (Waitlist Group)

  5. 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.

    Time frame: Baseline, Month 3, and Month 6

  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.

    Time frame: Month 3 (Experimental Group) and Month 6 (Waitlist Group)

07

Study locations

1 site
  • Tianshui Wulin Sub-district Community Health Service Center
    Hangzhou, Zhejiang, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2026; primary completion for Dec 2026, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2026
First posted
May 22, 2026
StartEst.
Jun 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Jul 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07601321
Lead sponsor
Hangzhou Normal University
Responsible party
Bofeng Ye (Principal Investigator, Hangzhou Normal University) — Principal investigator
First posted
May 22, 2026
Start date
Jun 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 9, 2026

Study contacts

Xuejiao Zhu, PhD
principal investigator · Hangzhou Normal University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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