- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07616219
Exergaming-based Sitting Tai Chi for Sarcopenia and/or Frailty
4. června 2026 aktualizováno: 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, upper-limb dexterity, cognitive performance, reaction time, mood, 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.
Přehled studie
Postavení
Zápis na pozvánku
Detailní popis
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, upper-limb dexterity, global cognition, reaction time, anxiety, depression, 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.
Typ studie
Intervenční
Zápis (Odhadovaný)
152
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Kowloon
-
Ho Man Tin, Kowloon, Hongkong
- Exergaming Research Centre, Hong Kong Metropolitan University
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
|
|
Komparátor placeba: 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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Maximal handgrip strength
Časové okno: 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).
|
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.
|
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).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Skeletal Muscle Mass Index (SMI)
Časové okno: 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).
|
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.
|
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).
|
|
Lower-Extremity Function (Five Times Sit-to-Stand Test)
Časové okno: 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).
|
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.
|
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).
|
|
Independence in Activities of Daily Living (Katz ADL-C)
Časové okno: 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).
|
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.
|
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).
|
|
Upper-Limb Dexterity on the Box and Block Test
Časové okno: 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).
|
Change in upper-limb dexterity and eye-hand coordination measured by a modified Box and Block Test.
Participants are instructed to transfer 9 wooden cubes, one at a time, over a central partition as quickly as possible using the dominant hand.
The total time required to transfer all 9 cubes is recorded in seconds.
Higher scores (shorter completion times) indicate better upper-limb dexterity and eye-hand coordination.
|
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).
|
|
Global Cognition on the Montreal Cognitive Assessment, Chinese Version
Časové okno: 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).
|
Change in global cognition measured by the Chinese version of the Montreal Cognitive Assessment (MoCA).
Total scores range from 0 to 30, with higher scores indicating better cognitive function.
|
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).
|
|
Reaction Time on a Computer-Based Finger-Press Reaction Task
Časové okno: 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).
|
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.
|
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).
|
|
Anxiety on the Chinese Hospital Anxiety and Depression Scale Anxiety Subscale
Časové okno: 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).
|
Change in anxiety symptoms measured by the anxiety subscale of the Chinese Hospital Anxiety and Depression Scale (HADS-A).
Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
|
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).
|
|
Depression on the Chinese Hospital Anxiety and Depression Scale Depression Subscale
Časové okno: 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).
|
Change in depressive symptoms measured by the depression subscale of the Chinese Hospital Anxiety and Depression Scale (HADS-D).
Scores range from 0 to 21, with higher scores indicating more severe depressive symptoms.
|
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).
|
|
Health-Related Quality of Life on the EQ-5D-5L Utility Index
Časové okno: 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).
|
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.
|
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).
|
|
Sitting Balance and Functional Reach (Modified Functional Reach Test)
Časové okno: 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).
|
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.
|
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).
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Tai Wa Liu, PhD, Hong Kong Metropolitan University
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. března 2026
Primární dokončení (Odhadovaný)
30. září 2027
Dokončení studie (Odhadovaný)
31. prosince 2027
Termíny zápisu do studia
První předloženo
21. května 2026
První předloženo, které splnilo kritéria kontroly kvality
29. května 2026
První zveřejněno (Aktuální)
1. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
8. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
4. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ETC - LTCF
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
De-identified individual participant data underlying the published results may be made available upon reasonable request.
Časový rámec sdílení IPD
After the study published.
Typ podpůrných informací pro sdílení IPD
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Sarkopenie u seniorů
-
Meshalkin Research Institute of Pathology of CirculationZatím nenabírámepevnostní vlastnosti aorty in vivo | pevnostní vlastnosti aorty in vitro | Regresní model pevnostních vlastností aorty in vitro a in vitroRuská Federace
-
University of Central FloridaThe IVF Center at Winter ParkNáborInvitro hnojení | Léčba oplodněním in vitro (IVF). | Stárnutí vaječníků | Výsledek oplodnění in vitroSpojené státy
-
Dana-Farber Cancer InstituteMassachusetts General Hospital; Beth Israel Deaconess Medical Center; Brigham...Aktivní, ne náborDuktální karcinom prsu in situSpojené státy
-
Centre Hospitalier Universitaire de NīmesDokončeno
-
Organon and CoDokončeno
-
Kaohsiung Veterans General Hospital.Dokončeno
-
Kaohsiung Veterans General Hospital.Dokončeno
-
Istituto Clinico HumanitasDokončeno
Klinické studie na Exergaming-based sitting Tai Chi
-
Harvard University Faculty of MedicineBeth Israel Deaconess Medical Center; Brigham and Women's HospitalDokončeno
-
Lidian ChenPeking University Third HospitalZatím nenabíráme
-
Chengdu University of Traditional Chinese MedicineZatím nenabírámeKvalita života | Dialýza; Komplikace | Čínská medicína
-
Jinan University GuangzhouChaozhou Special Education SchoolDokončenoPorucha autistického spektra (ASDČína
-
University Hospital, Clermont-FerrandDokončeno
-
Taipei Veterans General Hospital, TaiwanNational Science Council, TaiwanDokončeno
-
Sheba Medical CenterTel Aviv UniversityStaženoRakovina vaječníků | Primární peritoneální rakovina | Jiné gynekologické rakovinyIzrael
-
Tufts Medical CenterNational Center for Complementary and Integrative Health (NCCIH)Dokončeno
-
Hartford HospitalNábor
-
Texas Tech University Health Sciences CenterDokončeno