Aging, Frailty, Functional Impairment
Conditions
Keywords
Non-immersive virtual reality, Balance, Cognition, Occupational participation
Brief summary
Population aging is associated with an increased risk of frailty, falls, and loss of autonomy. This pilot study aims to evaluate the effects of a program that combines multicomponent exercise and non-immersive virtual reality (MCE+VR-NI), compared with virtual reality alone (VR-NI) and usual treatment. The primary objective is to determine the program's impact on physical function, balance, cognition, and occupational participation in community-dwelling adults aged over 65 years.
Detailed description
This is a mixed-methods pilot study consisting of a two-arm randomized controlled trial and a non-randomized parallel cohort for the control group. Participants will be allocated in a 1:1:1 ratio to the intervention or control groups. The intervention period will last 8 weeks. Quantitative outcomes (SPPB, FRAIL Scale, TUG, MoCA, COPM, WHODAS 2.0) will be assessed at baseline and post-intervention. In addition, qualitative interviews will be conducted to explore participants' subjective experiences and motivation.
Interventions
BEHAVIORALMulticomponent Exercise plus Non-Immersive Virtual Reality
Participants will undergo an 8-week multicomponent exercise program combined with non-immersive virtual reality (VR). Sessions will be conducted twice weekly (60 minutes each) and will include strength, balance, coordination, and functional mobility training, along with VR-based motor and cognitive stimulation using a non-immersive system. The intervention will be delivered in a supervised group setting.
BEHAVIORALNon-Immersive Virtual Reality
Participants will receive non-immersive virtual reality training for 8 weeks, with two supervised sessions per week (60 minutes each), focused on motor and cognitive stimulation.
Sponsors
European University Miguel de Cervantes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to the participants' group assignment.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants must be aged 65 years or older. * A score of ≥23 points on the Montreal Cognitive Assessment (MoCA) score * Functional independence or minimal dependence in activities of daily living (A score of \>90 on the Barthel Index). * Participants must be able to understand instructions and provide written informed consent.
Exclusion criteria
* Conditions that prevent walking or safe participation in a group intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical function (SPPB score) | Baseline and 8 weeks | Physical function will be assessed using the Short Physical Performance Battery (SPPB), which includes balance, gait speed, and chair stand tests, with a total score ranging from 0 to 12. Higher scores indicate better physical function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mobility (Timed Up and Go test) | Baseline and 8 weeks | Mobility will be assessed using the Timed Up and Go (TUG) test. The time in seconds required to stand up from a chair, walk three meters, turn, walk back, and sit down will be recorded, with no fixed minimum or maximum score. Lower times indicate better mobility and lower fall risk. |
| Change in handgrip strength | Baseline and 8 weeks | Handgrip strength will be measured in kilograms using a Jamar dynamometer, with no fixed minimum or maximum score. Higher values indicate greater muscular strength. |
| Change in cognitive function (MoCA score) | Baseline and 8 weeks | Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a screening tool that evaluates multiple cognitive domains including memory, attention, language, executive function, and visuospatial abilities, with a score ranging from 0 to 30. Higher scores indicate better cognitive function. |
| Change in frailty status (FRAIL Scale) | Baseline and 8 weeks | Frailty will be assessed using the FRAIL Scale, which includes five domains: fatigue, resistance, ambulation, illnesses, and weight loss, with a score ranging from 0 to 5. Higher scores indicate greater frailty. |
| Change in occupational performance and satisfaction (COPM) | Baseline and 8 weeks | Occupational performance and satisfaction will be assessed using the Canadian Occupational Performance Measure (COPM), which evaluates self-perceived performance and satisfaction in meaningful daily activities. Participants identify up to five priority activities in daily living, which are then rated for performance and satisfaction on scales ranging from 1 (not able to do it / not satisfied at all) to 10 (able to do it extremely well / extremely satisfied). Higher scores indicate better perceived performance and satisfaction. Changes in occupational performance will be assessed based on COPM scores. |
| Change in disability and participation (WHODAS 2.0) | Baseline and 8 weeks | Disability and participation will be assessed using the WHODAS 2.0 (36-item version), which evaluates functioning across multiple domains, with a standardized score ranging from 0 to 100. Higher scores indicate greater disability. |
Countries
Spain
Contacts
CONTACTOlga I Fernández Rodríguez, Dr.
Outcome results
None listed