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Not Yet RecruitingNCT07529743

Multicomponent Exercise and Virtual Reality for Older Adults

Effects of a Combined Multicomponent Exercise and Non-Immersive Virtual Reality Program on Functionality, Balance, Cognition, and Occupational Participation in Older Adults: A Mixed-Methods Pilot Study With a Control Group

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
European University Miguel de Cervantes · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMulticomponent Exercise plus Non-Immersive Virtual RealityParticipants 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 RealityParticipants 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.

Timeline

Start date
2026-04-07
Primary completion
2026-06-30
Completion
2026-07-31
First posted
2026-04-14
Last updated
2026-04-14

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07529743. Inclusion in this directory is not an endorsement.