Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Effects and Mechanisms of a Virtual Reality-Based Multidomain Intervention in Older Adults With Cognitive Frailty: A Randomized Controlled Trial
This randomized controlled trial will evaluate the effects of a virtual reality (VR) multidomain intervention on cognitive function in older adults with cognitive frailty and explore its underlying mechanisms.
Participants will receive either supervised VR training twice weekly for 8 weeks or multidomain health education. The VR program combines cognitive training, physical exercise, nutrition education, and emotional support.
Cognitive function, physical function, emotional symptoms, and nutritional status will be assessed at baseline and Week 8. Functional near-infrared spectroscopy will assess brain activity to explore potential mechanisms. Intervention feasibility, acceptability, and safety will also be evaluated.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Qian Liu
- Telefonnummer: Master's degre +86 13175250076
- E-Mail: shiliuqiana@163.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age >60 years.
- FFP score ≥1.
- MMSE ≥24 and either SCD-Q9 ≥5 or MoCA <26.
- ADL score ≤26.
- Ability to follow instructions, communicate discomfort, and safely participate in VR training.
- Written informed consent.
Exclusion Criteria:
- Dementia, stroke, Parkinson's disease, spinal cord injury, or epilepsy.
- Medical, psychiatric, or neurological conditions that prevent safe participation.
- Severe or recurrent vertigo, motion sickness, or intolerance to VR.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Virtual Reality Multidomain Intervention
Participants will receive supervised virtual reality multidomain training twice weekly for 8 weeks, for a total of 16 sessions. Each session is planned to last approximately 45 minutes, including instruction, warm-up, intermittent VR training, breaks, and task transitions. The program combines cognitive training, physical exercise, nutrition education, and emotional support. Task difficulty and training duration will be adjusted according to individual abilities and tolerance. |
A supervised VR program combining cognitive training, physical exercise, nutrition education, and emotional support. Participants attend two sessions weekly for 8 weeks, totaling 16 sessions. Each 45-minute session includes instruction, warm-up, approximately 25 minutes of intermittent VR training, and breaks. VR training includes approximately 10 minutes of cognitive training, 10 minutes of physical exercise, and 5 minutes of nutrition education or emotional support. Nutrition and emotional support activities alternate between the two weekly sessions. VR familiarization is provided before formal training. Task difficulty and training duration are adjusted to individual abilities and tolerance. |
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Aktiver Komparator: Multidomain Health Education
Participants will receive multidomain health education covering cognitive health, physical activity, nutrition, and emotional well-being. |
Participants will receive multidomain health education covering cognitive health, physical activity, nutrition, and emotional well-being. The educational content addresses the same health domains as the VR intervention. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
Zeitfenster: Baseline and Week 8 (end of intervention)
|
The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive function. |
Baseline and Week 8 (end of intervention)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Short Physical Performance Battery
Zeitfenster: Baseline and Week 8 (end of intervention)
|
The Short Physical Performance Battery (SPPB) will be used to assess lower-extremity physical function through standing balance, walking speed, and repeated chair stands. Total scores range from 0 to 12, with higher scores indicating better physical performance. |
Baseline and Week 8 (end of intervention)
|
|
Fried Frailty Phenotype
Zeitfenster: Baseline and Week 8 (end of intervention)
|
The Fried Frailty Phenotype (FFP) will be used to assess physical frailty based on five criteria: unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity. Total scores range from 0 to 5, with higher scores indicating greater frailty. |
Baseline and Week 8 (end of intervention)
|
|
Timed Up and Go Test (TUG)
Zeitfenster: Baseline and Week 8 (end of intervention)
|
The Timed Up and Go (TUG) test will be used to assess functional mobility. Participants rise from a chair, walk 3 meters, turn, walk back, and sit down. Completion time is recorded in seconds, with shorter times indicating better functional mobility. |
Baseline and Week 8 (end of intervention)
|
|
Patient Health Questionnaire-9 (PHQ-9)
Zeitfenster: Baseline and Week 8 (end of intervention)
|
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depressive symptoms over the preceding two weeks. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. |
Baseline and Week 8 (end of intervention)
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- PUMCSON-2025-21
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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