Multicomponent Exercise and Virtual Reality for Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multicomponent Exercise plus Non-Immersive Virtual Reality, Non-Immersive Virtual Reality.
- Who it may be relevant to
- Registry conditions: Frailty, Aging, Functional Impairment. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- Behavioral Multicomponent 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. - Behavioral Non-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.
Primary outcome measures
- Change in physical function (SPPB score) [Time frame: Baseline and 8 weeks]
Secondary outcome measures (6)
- Change in mobility (Timed Up and Go test) [Time frame: Baseline and 8 weeks]
- Change in handgrip strength [Time frame: Baseline and 8 weeks]
- Change in cognitive function (MoCA score) [Time frame: Baseline and 8 weeks]
- Change in frailty status (FRAIL Scale) [Time frame: Baseline and 8 weeks]
- Change in occupational performance and satisfaction (COPM) [Time frame: Baseline and 8 weeks]
- Change in disability and participation (WHODAS 2.0) [Time frame: Baseline and 8 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- INNOVEAS Innovation Center, Spanish Red Cross (Valladolid), Spain — Valladolid
Publications
- Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2. PMID 30703272
- Izquierdo M, Merchant RA, Morley JE, Anker SD, Aprahamian I, Arai H, Aubertin-Leheudre M, Bernabei R, Cadore EL, Cesari M, Chen LK, de Souto Barreto P, Duque G, Ferrucci L, Fielding RA, Garcia-Hermoso A, Gutierrez-Robledo LM, Harridge SDR, Kirk B, Kritchevsky S, Landi F, Lazarus N, Martin FC, Marzetti E, Pahor M, Ramirez-Velez R, Rodriguez-Manas L, Rolland Y, Ruiz JG, Theou O, Villareal DT, Waters PMID 34409961
- Gine-Garriga M, Roque-Figuls M, Coll-Planas L, Sitja-Rabert M, Salva A. Physical exercise interventions for improving performance-based measures of physical function in community-dwelling, frail older adults: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2014 Apr;95(4):753-769.e3. doi: 10.1016/j.apmr.2013.11.007. Epub 2013 Nov 27. PMID 24291597
Identifiers
NCT: NCT07529743 · Line1-MOVE ON. 090120260362026 · Line 1- MOVE ON