- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07616219
Exergaming-based Sitting Tai Chi for Sarcopenia and/or Frailty
29 июня 2026 г. обновлено: Dr Liu Tai Wa, Hong Kong Metropolitan University
Exergaming-based Sitting Tai Chi for Older Adults in Residential Care at Risk of Sarcopenia and/or Frailty
This randomized controlled trial will evaluate the effects of an exergaming-based sitting Tai Chi program on muscle strength, physical function, cognition, and psychosocial outcomes in older adults living in residential care facilities who are at risk of sarcopenia and/or prefrailty.
Eligible participants aged 60 years or older will be identified using simple screening criteria for sarcopenia and prefrailty and will not meet full diagnostic criteria for sarcopenia or frailty.
A total of 152 participants will be randomly assigned to either an individually supervised exergaming-based sitting Tai Chi intervention or a group-based general health education control, each delivered twice weekly for 12 weeks.
The primary outcome is dominant-hand grip strength, a core indicator of sarcopenia-related muscle weakness.
Key secondary outcomes include sitting balance and functional reach assessed by the Modified Functional Reach Test, with additional secondary measures of muscle mass, lower-extremity function, activities of daily living, reaction time and health-related quality of life.
Outcomes will be assessed at baseline, mid-intervention, post-intervention, and 3-month follow-up.
The findings will provide preliminary evidence on whether chair-based exergaming Tai Chi can be integrated into routine residential care to support healthy aging and functional independence.
Обзор исследования
Статус
Запись по приглашению
Вмешательство/лечение
Подробное описание
This randomized controlled trial will evaluate the effects of an exergaming-based sitting Tai Chi program on sarcopenia-related muscle weakness, balance, physical function, cognition, and psychosocial outcomes in older adults living in residential care facilities who are at risk of sarcopenia and/or prefrailty.
Sarcopenia and frailty are common in residential care and are associated with falls, disability, loss of independence, and mortality.
Although conventional exercise and Tai Chi may improve physical function, participation can be difficult for residents with mobility limitations, fluctuating health status, or low motivation.
Sitting Tai Chi offers a lower impact alternative, and exergaming may further enhance engagement by providing interactive tasks and real-time feedback.
This single-blind, parallel group randomized controlled trial will recruit 152 participants aged 60 years or older from collaborating residential care facilities.
Eligible participants must have screening indicators of sarcopenia or prefrailty, score at least 7 on the Chinese (Hong Kong) version of the Abbreviated Mental Test, be able to stand independently for assessment, and be able to follow intervention instructions.
Residents with confirmed sarcopenia, confirmed frailty, severe cognitive or sensory impairment, unstable medical conditions, prior regular Tai Chi practice, or current participation in another clinical trial will be excluded.
Participants will be randomly allocated in a 1:1 ratio to either an exergaming-based sitting Tai Chi group or a general health education control group, stratified by age, gender, and prefrailty status.
Randomization will be performed by an independent off-site researcher using computer software.
Outcome assessors and the statistician will be blinded to group allocation, although participants and intervention providers cannot be blinded because of the nature of the intervention.
The intervention group will receive a 12-week exergaming-based sitting Tai Chi program delivered twice weekly in 60-minute sessions.
The program uses a 12-form sitting Tai Chi exergame with body tracking and real-time feedback.
Training progresses from learning mode to skill-specific training and game modes, with a focus on balance control, eye-hand coordination, and limb flexibility.
The control group will receive time-matched general health education sessions on generic health topics relevant to older adults, without any content related to sarcopenia, frailty, exercise, or physical activity.
All participants will continue to receive usual care and routine activities provided by their residential care facility.
Outcome assessments will be conducted at baseline, mid-intervention, post-intervention, and 3-month follow-up.
The primary outcome is dominant-hand grip strength.
The key secondary outcome is sitting balance and functional reach assessed by the Modified Functional Reach Test.
Other secondary outcomes include skeletal muscle mass index, lower-extremity function, activities of daily living, reaction time and health-related quality of life.
Data will be analyzed according to the intention-to-treat principle using linear mixed-effects models to examine group-by-time effects.
This trial will provide preliminary evidence on whether chair-based exergaming Tai Chi is an effective and practical intervention for older adults at risk of sarcopenia and/or prefrailty in residential care settings.
Тип исследования
Интервенционный
Регистрация (Оцененный)
152
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Kowloon
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Ho Man Tin, Kowloon, Гонконг
- Exergaming Research Centre, Hong Kong Metropolitan University
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- aged ≥60 years;
- at risk of sarcopenia and/or prefrailty. At risk of sarcopenia is defined as meeting at least one of the following criteria: SARC-F (Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls) score ≥4, calf circumference <34 cm for men or <33 cm for women, while prefrailty is defined as a Fried Frailty Phenotype score of 1-2;
- score ≥7 on the Chinese (Hong Kong) version of the Abbreviated Mental Test;
- can stand independently for assessment; and
- can understand and follow intervention and assessment instructions.
Exclusion Criteria:
- absence of full diagnostic criteria is required; therefore residents with confirmed sarcopenia as defined by the Asian Working Group for Sarcopenia 2019 or confirmed frailty as defined by the Fried Frailty Phenotype (score 3-5) will be excluded;
- severe cognitive, sensory, or communication impairments not adequately corrected with aids;
- uncontrolled medical, neurological, orthopaedic, cardiovascular, or psychiatric conditions that preclude safe participation;
- prior experience of regular practice of Tai Chi >1 month; or
- current participation in another clinical trial.
- absence of full diagnostic criteria is required; therefore, residents with confirmed sarcopenia as defined by the Asian Working Group for Sarcopenia 2019 or confirmed frailty as defined by the Fried Frailty Phenotype (score 3-5) will be excluded;
- severe cognitive, sensory, or communication impairments not adequately corrected with aids;
- uncontrolled medical, neurological, orthopedic, cardiovascular, or psychiatric conditions that preclude safe participation;
- prior regular practice of Tai Chi for more than 1 month; or
- current participation in another clinical trial.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Exergaming-based sitting Tai Chi
Participants allocated to the intervention group will receive a structured exergaming-based seated Tai Chi program.
The program uses a 12-form seated Tai Chi exergame delivered in 24 sessions over 12 weeks, with each session lasting approximately 60 minutes.
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The structure and content of the 12-form seated Tai Chi routine build on earlier sitting Tai Chi programs developed by Tsang and colleagues for frail older adults and neurological populations.
The program targets three domains: (i) balance control, (ii) eye-hand coordination, and (iii) limb flexibility.
Training is organized into progressive phases (learning, skill-specific training, and game modes).
Each session begins with a 5-minute warm-up and ends with cool-down stretching and breathing exercises.
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Плацебо Компаратор: General health education
Participants allocated to the control group will attend small-group health education sessions focusing on general health topics relevant to older adults (e.g., oral health, common colds, and skin care) for 24 sessions over 12 weeks, with each session lasting approximately 60 minutes.
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Health education will be delivered using audio visual materials, brief talks and interactive discussion to provide engaging but non specific information about daily health management.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Maximal handgrip strength
Временное ограничение: Baseline (Week 0), mid-intervention (Week 6, after 12 sessions), post-intervention (Week 12, after 24 sessions), and 3-month follow-up (Week 24, approximately 12 weeks after the final intervention session).
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Change in maximal handgrip strength (kg) measured with a Jamar Plus+ Digital Hand Dynamometer.
Participants are seated with the elbow flexed at approximately 90 degrees.
Three trials per hand are performed, and the highest value recorded from either hand is used.
Higher values indicate greater muscle strength.
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Baseline (Week 0), mid-intervention (Week 6, after 12 sessions), post-intervention (Week 12, after 24 sessions), and 3-month follow-up (Week 24, approximately 12 weeks after the final intervention session).
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Skeletal Muscle Mass Index (SMI)
Временное ограничение: Baseline (Week 0), mid-intervention (Week 6, after 12 sessions), post-intervention (Week 12, after 24 sessions), and 3-month follow-up (Week 24, approximately 12 weeks after the final intervention session).
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Change in skeletal muscle mass index (kg/m²) assessed by multi-frequency bioelectrical impedance analysis (MC-780MA, TANITA).
Appendicular skeletal muscle mass is obtained from device output and divided by height squared to calculate SMI (kg/m²).
Higher values indicate greater muscle mass.
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Baseline (Week 0), mid-intervention (Week 6, after 12 sessions), post-intervention (Week 12, after 24 sessions), and 3-month follow-up (Week 24, approximately 12 weeks after the final intervention session).
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Lower-Extremity Function (Five Times Sit-to-Stand Test)
Временное ограничение: Baseline (Week 0), mid-intervention (Week 6, after 12 sessions), post-intervention (Week 12, after 24 sessions), and 3-month follow-up (Week 24, approximately 12 weeks after the final intervention session).
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Change in performance on the Five Times Sit-to-Stand Test.
Participants stand up and sit down five times as quickly as possible from a standard-height chair without using their arms.
Time to completion (seconds) is recorded with a stopwatch.
Shorter times indicate better lower-extremity function.
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Baseline (Week 0), mid-intervention (Week 6, after 12 sessions), post-intervention (Week 12, after 24 sessions), and 3-month follow-up (Week 24, approximately 12 weeks after the final intervention session).
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Independence in Activities of Daily Living (Katz ADL-C)
Временное ограничение: Baseline (Week 0), mid-intervention (Week 6, after 12 sessions), post-intervention (Week 12, after 24 sessions), and 3-month follow-up (Week 24, approximately 12 weeks after the final intervention session).
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Change in independence in basic activities of daily living measured by the Chinese version of the Katz Index of Independence in Activities of Daily Living (Katz ADL-C).
Items cover bathing, transferring, dressing, toileting, eating, and continence.
Total scores range from 0 to 6, with higher scores indicating greater dependence in basic activities of daily living.
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Baseline (Week 0), mid-intervention (Week 6, after 12 sessions), post-intervention (Week 12, after 24 sessions), and 3-month follow-up (Week 24, approximately 12 weeks after the final intervention session).
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Reaction Time on a Computer-Based Finger-Press Reaction Task
Временное ограничение: Baseline (Week 0), mid-intervention (Week 6, after 12 sessions), post-intervention (Week 12, after 24 sessions), and 3-month follow-up (Week 24, approximately 12 weeks after the final intervention session).
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Change in reaction time measured by a computer-based finger-press reaction task.
Participants respond as quickly as possible when an on-screen box changes color at random intervals.
Mean reaction time is recorded in milliseconds.
Lower values indicate faster reaction time.
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Baseline (Week 0), mid-intervention (Week 6, after 12 sessions), post-intervention (Week 12, after 24 sessions), and 3-month follow-up (Week 24, approximately 12 weeks after the final intervention session).
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Health-Related Quality of Life on the EQ-5D-5L Utility Index
Временное ограничение: Baseline (Week 0), mid-intervention (Week 6, after 12 sessions), post-intervention (Week 12, after 24 sessions), and 3-month follow-up (Week 24, approximately 12 weeks after the final intervention session).
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Change in health-related quality of life measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) utility index.
Health states are converted to a utility score using the Hong Kong-specific EQ-5D-5L value set.
Utility scores range from values below 0 (health states considered worse than death) up to 1.0 (full health), with higher utility scores indicating better health-related quality of life.
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Baseline (Week 0), mid-intervention (Week 6, after 12 sessions), post-intervention (Week 12, after 24 sessions), and 3-month follow-up (Week 24, approximately 12 weeks after the final intervention session).
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Sitting Balance and Functional Reach (Modified Functional Reach Test)
Временное ограничение: Baseline (Week 0), mid-intervention (Week 6, after 12 sessions), post-intervention (Week 12, after 24 sessions), and 3-month follow-up (Week 24, approximately 12 weeks after the final intervention session).
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Change in sitting balance and forward and lateral functional reach distance (cm) measured by the Modified Functional Reach Test (mFRT).
Participants sit on a backless, standard-height chair with hips and knees at approximately 90 degrees and feet flat on the floor.
With the shoulder flexed to 90 degrees and the elbow extended, participants reach forward and laterally as far as possible without losing balance or taking a step.
The maximal distance reached in each direction by the third metacarpal is recorded using a wall-mounted tape measure.
After two practice trials, three test trials are performed in each direction and the mean distance in each direction is used.
Greater distances indicate better sitting balance and functional reach.
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Baseline (Week 0), mid-intervention (Week 6, after 12 sessions), post-intervention (Week 12, after 24 sessions), and 3-month follow-up (Week 24, approximately 12 weeks after the final intervention session).
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Tai Wa Liu, PhD, Hong Kong Metropolitan University
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 марта 2026 г.
Первичное завершение (Оцененный)
30 сентября 2027 г.
Завершение исследования (Оцененный)
31 декабря 2027 г.
Даты регистрации исследования
Первый отправленный
21 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
29 мая 2026 г.
Первый опубликованный (Действительный)
1 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
1 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
29 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ETC - LTCF
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
De-identified individual participant data underlying the published results may be made available upon reasonable request.
Сроки обмена IPD
After the study published.
Совместное использование IPD Поддерживающий тип информации
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .