BCW-Based Resistance Training for Community-Dwelling Sarcopenia Patients (BCW-RES)
Effects of a Behavior Change Wheel (BCW)-Based Resistance Exercise Program on Community-Dwelling Patients With Sarcopenia: A Randomized Controlled Trial
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Zhejiang
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Hangzhou, Zhejiang, Китай
- Tianshui Wulin Sub-district Community Health Service Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: 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.
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Экспериментальный: Resistance Training Group
Participants in this group will receive the BCW-based resistance exercise program immediately for 12 weeks (twice weekly).
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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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Skeletal Muscle Mass Index
Временное ограничение: Baseline, 3 months, and 6 months
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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).
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Baseline, 3 months, and 6 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Handgrip Strength
Временное ограничение: Baseline, Month 3, and Month 6
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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.
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Baseline, Month 3, and Month 6
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6-Meter Gait Speed
Временное ограничение: Baseline, Month 3, and Month 6
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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.
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Baseline, Month 3, and Month 6
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Self-Efficacy for Exercise Scale - Chinese Version (SEE-C) Score
Временное ограничение: 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.
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Baseline, Month 3, and Month 6
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Exercise Adherence Rate
Временное ограничение: Month 3 (Experimental Group) and Month 6 (Waitlist Group)
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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.
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Month 3 (Experimental Group) and Month 6 (Waitlist Group)
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Sarcopenia Quality of Life (SarQoL) Questionnaire Score
Временное ограничение: Baseline, Month 3, and Month 6
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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.
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Baseline, Month 3, and Month 6
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Participant satisfaction
Временное ограничение: Month 3 (Experimental Group) and Month 6 (Waitlist Group)
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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.
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Month 3 (Experimental Group) and Month 6 (Waitlist Group)
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Xuejiao Zhu, PhD, Hangzhou Normal University
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2026017
- YJSYC202603152 (Другой номер гранта/финансирования: Hangzhou Normal University)
Планирование данных отдельных участников (IPD)
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