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NCT Number: NCT07529743

Multicomponent Exercise and Virtual Reality for Older Adults

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.

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Key information

Conditions

Frailty Aging Functional Impairment Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Valladolid, Spain

Location contact

Olga I Fernández Rodríguez, Dr.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Olga I Fernández Rodríguez, Dr.

CONTACT

[email protected]

+34 983 001 000

Sponsors and collaborators

Lead sponsor

European University Miguel de Cervantes

Other

Registry information

Official study 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

Acronym: MOVE ON

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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