BCW-Based Resistance Training for Community-Dwelling Sarcopenia Patients

NCT07601321 | Not Yet Recruiting

• 2 other identifiers: 2026017YJSYC202603152
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

Sarcopenia; Resistance Exercise; Behavior Change Wheel

Outcome Measures

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).

  Baseline, 3 months, and 6 months

Secondary Outcomes (6)

• Handgrip Strength

  Baseline, Month 3, and Month 6

• 6-Meter Gait Speed

  Baseline, Month 3, and Month 6

• Self-Efficacy for Exercise Scale - Chinese Version (SEE-C) Score

  Baseline, Month 3, and Month 6

• Exercise Adherence Rate

  Month 3 (Experimental Group) and Month 6 (Waitlist Group)

• Sarcopenia Quality of Life (SarQoL) Questionnaire Score

  Baseline, Month 3, and Month 6

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

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.

Interventions

BCW-Based Resistance Exercise Program BEHAVIORAL

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.

Experimental Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hangzhou Normal University: lead

Study Sites (1)

Tianshui Wulin Sub-district Community Health Service Center

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Xuejiao Zhu, PhD

  Hangzhou Normal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bofeng Ye, MS Candidate

CONTACT

+86-17816780360; ybf0821@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors for physiological outcomes and questionnaires are blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Student

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)