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

2026년 7월 7일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Zhejiang
      • Hangzhou, Zhejiang, 중국
        • Tianshui Wulin Sub-district Community Health Service Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: 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.
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Skeletal Muscle Mass Index
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Handgrip Strength
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Xuejiao Zhu, PhD, Hangzhou Normal University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2026년 12월 1일

연구 등록 날짜

최초 제출

2026년 5월 15일

QC 기준을 충족하는 최초 제출

2026년 5월 15일

처음 게시됨 (실제)

2026년 5월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 7일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2026017
  • YJSYC202603152 (기타 보조금/기금 번호: Hangzhou Normal University)

개별 참가자 데이터(IPD) 계획

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아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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