FrailtyMOVE ONNCT07529743
Multicomponent Exercise and Virtual Reality for Older Adults
A study testing Multicomponent Exercise plus Non-Immersive Virtual Reality and Non-Immersive Virtual Reality in people with Frailty and Aging, run by European University Miguel de Cervantes at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Aging, Functional Impairment
- What is being tested?
- Multicomponent Exercise plus Non-Immersive Virtual Reality and Non-Immersive Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 7 Apr 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- Conditions that prevent walking or safe participation in a group intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
INNOVEAS Innovation Center, Spanish Red Cross (Valladolid), Spain
Valladolid, Valladolid
Olga I Fernández Rodríguez, Dr., oifernandez@uemc.es
About this study
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
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.
Read the 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.
- Conditions
- Frailty, Aging, Functional Impairment
- Being tested
- Multicomponent Exercise plus Non-Immersive Virtual Reality, Non-Immersive Virtual Reality
- Keywords
- Non-immersive virtual reality, Balance, Cognition, Occupational participation
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Exercise plus Non-Immersive Virtual RealityBehavioural
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 RealityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multicomponent Exercise plus Non-Immersive Virtual Reality |
| Virtual Reality Group (VR) | Active comparator | 8-week program using exclusively non-immersive virtual reality sessions. Receives: Behavioral: Non-Immersive Virtual Reality |
| Control Group | No intervention | Parallel cohort maintaining usual activities and only participating in pre and post-intervention assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (6)
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
Change in occupational performance and satisfaction (COPM)
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.
Measured: Baseline and 8 weeks
Change in disability and participation (WHODAS 2.0)
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start7 Apr 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European University Miguel de Cervantes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529743
- Sponsor's protocol ID
- Line1-MOVE ON. 090120260362026
- Other IDs
- Line 1- MOVE ON
- Acronym
- MOVE ON
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 30703272Izquierdo 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.
PubMed 34409961Gine-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.
PubMed 24291597
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07529743
- Acronym / sponsor ID
- MOVE ON / Line1-MOVE ON. 090120260362026
- Conditions
- Frailty, Aging, Functional Impairment
- Keywords
- Non-immersive virtual reality, Balance, Cognition, Occupational participation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- European University Miguel de CervantesUniversity, hospital or other
- Study start
- 7 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Exercise + Virtual Reality Group (MCE+VR) | Experimental | Behavioral: Multicomponent Exercise plus Non-Immersive Virtual Reality8-week combined program including strength, balance, and coordination training along with non-immersive virtual reality sessions. |
| Virtual Reality Group (VR) | Active comparator | Behavioral: Non-Immersive Virtual Reality8-week program using exclusively non-immersive virtual reality sessions. |
| Control Group | No intervention | –Parallel cohort maintaining usual activities and only participating in pre and post-intervention assessments |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Conditions that prevent walking or safe participation in a group intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent Exercise plus Non-Immersive Virtual RealityParticipants 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. | Behavioural | Multicomponent Exercise + Virtual Reality Group (MCE+VR) |
| Non-Immersive Virtual RealityParticipants 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. | Behavioural | Virtual Reality Group (VR) |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 30703272Sherrington 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.
- Background: PubMed 34409961Izquierdo 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.
- Background: PubMed 24291597Gine-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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Exercise plus Non-Immersive Virtual Reality and Non-Immersive Virtual Reality in people with Frailty and Aging, run by European University Miguel de Cervantes at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olga I Fernández Rodríguez, Dr. (+34 983 001 000, oifernandez@uemc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical function (SPPB score) (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07529743, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.