Multicomponent Exercise and Virtual Reality for Older Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorEuropean University Miguel de Cervantes
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Conditions that prevent walking or safe participation in a group intervention.
Trial design
Design model
Parallel
Treatments tested in this trial
Multicomponent Exercise plus Non-Immersive Virtual Reality
BehavioralParticipants 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.
Non-Immersive Virtual Reality
BehavioralParticipants 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Multicomponent Exercise + Virtual Reality Group (MCE+VR)Experimental treatment 1 intervention
Group B: Virtual Reality Group (VR)Active comparator 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in physical function (SPPB score)
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.
Time frame
Baseline and 8 weeksSecondary outcomes
1
Change in mobility (Timed Up and Go test)
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.
Time frame
Baseline and 8 weeks2
Change in handgrip strength
Handgrip strength will be measured in kilograms using a Jamar dynamometer, with no fixed minimum or maximum score. Higher values indicate greater muscular strength.
Time frame
Baseline and 8 weeks3
Change in cognitive function (MoCA score)
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.
Time frame
Baseline and 8 weeks4
Change in frailty status (FRAIL Scale)
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.
Time frame
Baseline and 8 weeksSponsors and contacts
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Source ClinicalTrials.gov
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