- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07616219
Exergaming-based Sitting Tai Chi for Sarcopenia and/or Frailty
4. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Anmeldung auf Einladung
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
152
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Kowloon
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Ho Man Tin, Kowloon, Hongkong
- Exergaming Research Centre, Hong Kong Metropolitan University
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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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Placebo-Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Maximal handgrip strength
Zeitfenster: 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.
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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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Skeletal Muscle Mass Index (SMI)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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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Upper-Limb Dexterity on the Box and Block Test
Zeitfenster: 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 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.
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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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Global Cognition on the Montreal Cognitive Assessment, Chinese Version
Zeitfenster: 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 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.
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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
Zeitfenster: 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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Anxiety on the Chinese Hospital Anxiety and Depression Scale Anxiety Subscale
Zeitfenster: 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 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.
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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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Depression on the Chinese Hospital Anxiety and Depression Scale Depression Subscale
Zeitfenster: 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 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.
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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
Zeitfenster: 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)
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Tai Wa Liu, PhD, Hong Kong Metropolitan University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. März 2026
Primärer Abschluss (Geschätzt)
30. September 2027
Studienabschluss (Geschätzt)
31. Dezember 2027
Studienanmeldedaten
Zuerst eingereicht
21. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Mai 2026
Zuerst gepostet (Tatsächlich)
1. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ETC - LTCF
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
De-identified individual participant data underlying the published results may be made available upon reasonable request.
IPD-Sharing-Zeitrahmen
After the study published.
Art der unterstützenden IPD-Freigabeinformationen
- SAFT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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