Multicomponent Exercise and Virtual Reality for Older Adults

NCT07529743 | Not Yet Recruiting

• 2 other identifiers: Line1-MOVE ON. 090120260362026Line 1- MOVE ON
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Aging; Functional Impairment

Keywords

Non-immersive virtual reality; Balance; Cognition; Occupational participation

Outcome Measures

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.

  Baseline and 8 weeks

Secondary Outcomes (6)

• Change in mobility (Timed Up and Go test)

  Baseline and 8 weeks

• Change in handgrip strength

  Baseline and 8 weeks

• Change in cognitive function (MoCA score)

  Baseline and 8 weeks

• Change in frailty status (FRAIL Scale)

  Baseline and 8 weeks

• Change in occupational performance and satisfaction (COPM)

  Baseline and 8 weeks

Study Arms (3)

Multicomponent Exercise + Virtual Reality Group (MCE+VR)

EXPERIMENTAL

8-week combined program including strength, balance, and coordination training along with non-immersive virtual reality sessions.

Behavioral: Multicomponent Exercise plus Non-Immersive Virtual Reality

Virtual Reality Group (VR)

ACTIVE COMPARATOR

8-week program using exclusively non-immersive virtual reality sessions.

Behavioral: Non-Immersive Virtual Reality

Control Group

NO INTERVENTION

Parallel cohort maintaining usual activities and only participating in pre and post-intervention assessments

Interventions

Non-Immersive Virtual Reality BEHAVIORAL

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.

Virtual Reality Group (VR)

Multicomponent Exercise plus Non-Immersive Virtual Reality BEHAVIORAL

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.

Multicomponent Exercise + Virtual Reality Group (MCE+VR)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Conditions that prevent walking or safe participation in a group intervention.

Sponsors & Collaborators

• European University Miguel de Cervantes: lead

Study Sites (1)

INNOVEAS Innovation Center, Spanish Red Cross (Valladolid), Spain

Valladolid, Valladolid, Spain

Location

Related Publications (3)

• 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 BACKGROUND

• 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 DL, Won Won C, Woo J, Vellas B, Fiatarone Singh M. International Exercise Recommendations in Older Adults (ICFSR): Expert Consensus Guidelines. J Nutr Health Aging. 2021;25(7):824-853. doi: 10.1007/s12603-021-1665-8.

  PMID: 34409961 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Olga I Fernández Rodríguez, Dr.

CONTACT

+34 983 001 000; oifernandez@uemc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to the participants' group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 14, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)