- ICH GCP
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- Ensaio Clínico NCT07616219
Exergaming-based Sitting Tai Chi for Sarcopenia and/or Frailty
29 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Inscrevendo-se por convite
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
152
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Kowloon
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Ho Man Tin, Kowloon, Hong Kong
- Exergaming Research Centre, Hong Kong Metropolitan University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Comparador de Placebo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Maximal handgrip strength
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Skeletal Muscle Mass Index (SMI)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Tai Wa Liu, PhD, Hong Kong Metropolitan University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de março de 2026
Conclusão Primária (Estimado)
30 de setembro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
21 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de maio de 2026
Primeira postagem (Real)
1 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ETC - LTCF
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
De-identified individual participant data underlying the published results may be made available upon reasonable request.
Prazo de Compartilhamento de IPD
After the study published.
Tipo de informação de suporte de compartilhamento de IPD
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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