Multicomponent Exercise and Virtual Reality for Older Adults (MOVE ON)

April 13, 2026 updated by: European University Miguel de Cervantes

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Olga I Fernández Rodríguez, Dr.
  • Phone Number: +34 983 001 000
  • Email: oifernandez@uemc.es

Study Locations

  • Spain
    • Valladolid
      • Valladolid, Valladolid, Spain
        • INNOVEAS Innovation Center, Spanish Red Cross (Valladolid), Spain
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multicomponent Exercise + Virtual Reality Group (MCE+VR)
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
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.
Active Comparator: Virtual Reality Group (VR)
8-week program using exclusively non-immersive virtual reality sessions.
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.
No Intervention: Control Group
Parallel cohort maintaining usual activities and only participating in pre and post-intervention assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in physical function (SPPB score)
Time Frame: 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.
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mobility (Timed Up and Go test)
Time Frame: 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.
Baseline and 8 weeks
Change in handgrip strength
Time Frame: 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.
Baseline and 8 weeks
Change in cognitive function (MoCA score)
Time Frame: 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.
Baseline and 8 weeks
Change in frailty status (FRAIL Scale)
Time Frame: 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.
Baseline and 8 weeks
Change in occupational performance and satisfaction (COPM)
Time Frame: 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.
Baseline and 8 weeks
Change in disability and participation (WHODAS 2.0)
Time Frame: 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.
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European University Miguel de Cervantes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 7, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Line1-MOVE ON. 090120260362026
  • Line 1- MOVE ON (Other Grant/Funding Number: 8th Call for Research Projects and Talent Retention of UEMC-Valladolid Provincial Council)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared in order to protect participant privacy and confidentiality, in accordance with informed consent procedures and applicable data protection regulations. Due to the small sample size typical of pilot studies and the potential risk of indirect identification, only aggregated and anonymized data will be reported in scientific publications and communications. All analyses will be conducted at the group level. Data will be handled and stored securely following institutional and ethical guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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