BCW-Based Resistance Training for Community-Dwelling Sarcopenia Patients (BCW-RES)

May 31, 2026 updated by: Bofeng Ye, Hangzhou Normal University

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bofeng Ye, MS Candidate
  • Phone Number: +86-17816780360
  • Email: ybf0821@163.com

Study Locations

    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Tianshui Wulin Sub-district Community Health Service Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Experimental: Resistance Training Group
Participants in this group will receive the BCW-based resistance exercise program immediately for 12 weeks (twice weekly).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handgrip Strength
Time Frame: 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.
Baseline, Month 3, and Month 6
6-Meter Gait Speed
Time Frame: 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.
Baseline, Month 3, and Month 6
Self-Efficacy for Exercise Scale - Chinese Version (SEE-C) Score
Time Frame: 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.
Baseline, Month 3, and Month 6
Exercise Adherence Rate
Time Frame: 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.
Month 3 (Experimental Group) and Month 6 (Waitlist Group)
Sarcopenia Quality of Life (SarQoL) Questionnaire Score
Time Frame: 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.
Baseline, Month 3, and Month 6
Participant satisfaction
Time Frame: 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.
Month 3 (Experimental Group) and Month 6 (Waitlist Group)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Xuejiao Zhu, PhD, Hangzhou Normal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 15, 2026

First Submitted That Met QC Criteria

May 15, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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