Disability PhysicalMOTOMEDNCT06340282
Immersive Virtual Reality and Physical Exercise on Cognitive and Functional Performance in Hospitalized Older Patients
A study testing Virtual reality and multicomponent exercise in people with Disability Physical and Cognition, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
This study will be conducted in a hospital in Spain to investigate how a special intervention using immersive virtual reality technology can benefit hospitalized older adults with difficulties in their daily functionality. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Disability Physical, Cognition
- What is being tested?
- Virtual reality and multicomponent exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2024to 1 Apr 2025
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 75 years Clinica Stability Expected length of stay ≥ 5 days Being able to communicate and collaborate with the research team
Who cannot join
- Barthel Index score ≥ 60 at admission Refusal to sign the informed consent by the patient/legal guardian or inability to obtain it Life expectancy less than three months End-stage disease Severe level of major neurocognitive disorder (GDS 7)
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, 1 recruiting
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
NICOLAS MARTINEZ-VELILLA, PHD, 0034670900434, nicolas.martinez.velilla@navarra.es
About this study
Official title: Effects of Immersive Virtual Reality and/or Multicomponent Physical Exercise on Cognitive and Functional Performance in Hospitalized Older Patients With Severe Functional Dependency: Study Protocol for a Randomized Clinical Trial
This study will be conducted in a hospital in Spain to investigate how a special intervention using immersive virtual reality technology can benefit hospitalized older adults with difficulties in their daily functionality.
The main objective of this study is to evaluate whether a cognitive stimulation intervention through immersive virtual reality, along with specific physical exercises, can improve the cognitive and physical function of hospitalized older patients. It is expected that this innovative intervention will have a positive impact on the quality of life of these patients.
Read more
Participants eligible for the study must be over 75 years old, have severe functional dependency upon hospital admission, and be willing to participate. Those with severe dementia or other terminal illnesses will be excluded.
Participants will be randomly assigned to one of four study groups: a control group without intervention and three intervention groups, including viewing Spanish landscapes through virtual reality, performing specific physical exercises, or a combination of both interventions.
At the end of the study, various aspects such as cognitive and physical function, mood, quality of life, muscle strength, and acceptance of virtual reality technology by patients will be evaluated.
This study aims to provide new insights into the care of hospitalized older adults and explore innovative ways to improve their well-being during their hospital stay
Read the detailed description
This study will be conducted in a Spanish tertiary hospital to investigate the impact of a cognitive stimulation intervention through immersive virtual reality (IVR) on hospitalized older adults with severe functional dependency. The study will also examine the combined effect of a multicomponent exercise intervention (ME) with IVR. A total of 212 acute patients will be enrolled in the Acute Geriatric Unit of the hospital, meeting specific inclusion criteria related to age, stability in cardiopulmonary, respiratory, and neurological systems, expected length of stay, and ability to communicate and collaborate with the research team. Patients will be randomly assigned to a control group or one of three intervention groups: IVR, ME, or IVR + ME.
The interventions for the IVR and ME groups will involve watching 3D videos of Spanish landscapes and undergoing progressive upper and lower extremity exercises, respectively. The IVR + ME group will receive both interventions, while the control group will receive usual care. Primary outcome measures include cognitive tests, strength assessments, and balance and mobility evaluations. Secondary outcome measures include mood, quality of life, functional performance, delirium assessments, and length of hospital stay.
The study will take place in the Acute Geriatric Unit (AGU) of a tertiary hospital in Pamplona, Navarra, Spain, and will adhere to standard clinical trial guidelines. Eligibility criteria include medical inpatients admitted to the AGU between January 2024 and March 2025, with specific inclusion and exclusion criteria. The study aims to evaluate the impact of the interventions on cognitive and physical function among hospitalized older adults with severe functional dependency, with the goal of enhancing their well-being and care during hospitalization.
The research team anticipates that the interventions will positively influence cognitive function, physical performance, mood, quality of life, isometric strength, and acceptance of virtual reality technology among participants. The study's comprehensive approach encompasses various assessments to provide a holistic evaluation of the interventions' effectiveness in improving outcomes for hospitalized older adults with severe functional dependency.
Overall, this study represents a significant effort to understand how innovative interventions such as cognitive stimulation through IVR and multicomponent physical exercise could positively impact the health outcomes and quality of life of hospitalized older adults with severe functional dependency. The study's findings are expected to provide valuable insights for healthcare providers, researchers, and policymakers seeking to optimize care for this population.
- Conditions
- Disability Physical, Cognition
- Being tested
- Virtual reality, multicomponent exercise
- Keywords
- hospital-associated functional decline, cognitive stimulation, immersive virtual reality, multicomponent physical exercise, disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Immersive virtual reality
multicomponent exerciseBehavioural
individualized exercise
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group |
| immersive virtual reality | Experimental | Patients use virtual reality Receives: Device: Virtual reality |
| multicomponent physical exercise intervention | Experimental | Individualized exercise intervention Receives: Behavioral: multicomponent exercise |
| Immersive virtual reality and multicomponent physical exercise intervention | Experimental | Both Receives: Device: Virtual reality; Behavioral: multicomponent exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (MMSE)
Cognitive evolution
Measured: Baseline, day 3, at discharge and 1 month after discharge
Secondary outcomes (1)
Isometric handgrip strength
Muscle strength measurement
Measured: Baseline, day 3, at discharge and 1 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disability PhysicalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This clinical randomized controlled trial will be conducted in the Acute Geriatric Unit of a tertiary hospital in Spain. A total of 212 acute patients will be enrolled according to the following criteria: age \> 75, Barthel Index \< 60, able to collaborate, expected length of stay \> 5 days, absence of clinical instability and severe dementia (GDS 7) or other end-stage disease. Patients will be randomly assigned to a control group (CG) or any of the three intervention groups (IG): IVR, ME, or IVR + ME. The IVR group will watch ad-hoc videos showing Spanish regional landscapes and villages, approximately 4 minutes per day for three consecutive days. The ME group will undergo aerobic and strength exercise for progressive training of the upper and lower limbs. The IVR + ME group will do both cognitive and physical intervention. The primary outcomes will be cognitive and physical measures at discharge. Mood, quality of life, isometric strength, and acceptance of IVR will be also assessed.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Martinez-Velilla Dr, PhD, Principal investigator, Fundación Miguel Servet - Navarrabiomed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340282
- Sponsor's protocol ID
- MOTOMED
- Acronym
- MOTOMED
- Status last verified
- Jan 2025
- First submitted
- 25 Mar 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan to share anonymized data from a randomized clinical trial in response to reasonable requests focuses on ensuring confidentiality and protecting the privacy of participants. This plan includes fully anonymizing the data, creating a detailed data sharing protocol, establishing an independent data review committee, implementing a clear request procedure, requiring confidentiality agreements to be signed by requestors, and applying robust security measures to protect data integrity. The primary goal is to facilitate access to data to promote transparency and scientific advancement while ensuring respect for the privacy and confidentiality of clinical trial participants. It is important to note that data will be shared under reasonable requests.
Publications
Cuevas-Lara C, Saez de Asteasu ML, Ramirez-Velez R, Izquierdo M, Zambom-Ferraresi F, Antonanzas-Valencia C, Galbete A, Zambom-Ferraresi F, Martinez-Velilla N. Effects of game-based interventions on functional capacity in acutely hospitalised older adults: results of an open-label non-randomised clinical trial. Age Ageing. 2022 Jan 6;51(1):afab247. doi: 10.1093/ageing/afab247.
PubMed 35077558de la Casa-Marin A, Zambom-Ferraresi F, Ferrara MC, Ollo-Martinez I, Galbete A, Gonzalez-Glaria B, Moral-Cuesta D, Marin-Epelde I, Chenhuichen C, Lorente-Escudero M, Molero-de-Avila R, Baztan AG, Zambom-Ferraresi F, Martinez-Velilla N. Effects of immersive virtual reality stimulation and/or multicomponent physical exercise on cognitive and functional performance in hospitalized older patients with severe functional dependency: study protocol for a randomized clinical trial. BMC Geriatr. 2024 Nov 8;24(1):924. doi: 10.1186/s12877-024-05516-x.
PubMed 39516806
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Immersive Virtual Reality and/or Multicomponent Physical Exercise on Cognitive and Functional Performance in Hospitalized Older Patients With Severe Functional Dependency: Study Protocol for a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06340282
- Acronym / sponsor ID
- MOTOMED / MOTOMED
- Conditions
- Disability Physical, Cognition
- Keywords
- hospital-associated functional decline, cognitive stimulation, immersive virtual reality, multicomponent physical exercise, disability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 1 Apr 2024 (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.
This study will be conducted in a hospital in Spain to investigate how a special intervention using immersive virtual reality technology can benefit hospitalized older adults with difficulties in their daily functionality.
The main objective of this study is to evaluate whether a cognitive stimulation intervention through immersive virtual reality, along with specific physical exercises, can improve the cognitive and physical function of hospitalized older patients. It is expected that this innovative intervention will have a positive impact on the quality of life of these patients.
Participants eligible for the study must be over 75 years old, have severe functional dependency upon hospital admission, and be willing to participate. Those with severe dementia or other terminal illnesses will be excluded.
Participants will be randomly assigned to one of four study groups: a control group without intervention and three intervention groups, including viewing Spanish landscapes through virtual reality, performing specific physical exercises, or a combination of both interventions.
At the end of the study, various aspects such as cognitive and physical function, mood, quality of life, muscle strength, and acceptance of virtual reality technology by patients will be evaluated.
This study aims to provide new insights into the care of hospitalized older adults and explore innovative ways to improve their well-being during their hospital stay
Detailed description
This study will be conducted in a Spanish tertiary hospital to investigate the impact of a cognitive stimulation intervention through immersive virtual reality (IVR) on hospitalized older adults with severe functional dependency. The study will also examine the combined effect of a multicomponent exercise intervention (ME) with IVR. A total of 212 acute patients will be enrolled in the Acute Geriatric Unit of the hospital, meeting specific inclusion criteria related to age, stability in cardiopulmonary, respiratory, and neurological systems, expected length of stay, and ability to communicate and collaborate with the research team. Patients will be randomly assigned to a control group or one of three intervention groups: IVR, ME, or IVR + ME.
The interventions for the IVR and ME groups will involve watching 3D videos of Spanish landscapes and undergoing progressive upper and lower extremity exercises, respectively. The IVR + ME group will receive both interventions, while the control group will receive usual care. Primary outcome measures include cognitive tests, strength assessments, and balance and mobility evaluations. Secondary outcome measures include mood, quality of life, functional performance, delirium assessments, and length of hospital stay.
The study will take place in the Acute Geriatric Unit (AGU) of a tertiary hospital in Pamplona, Navarra, Spain, and will adhere to standard clinical trial guidelines. Eligibility criteria include medical inpatients admitted to the AGU between January 2024 and March 2025, with specific inclusion and exclusion criteria. The study aims to evaluate the impact of the interventions on cognitive and physical function among hospitalized older adults with severe functional dependency, with the goal of enhancing their well-being and care during hospitalization.
The research team anticipates that the interventions will positively influence cognitive function, physical performance, mood, quality of life, isometric strength, and acceptance of virtual reality technology among participants. The study's comprehensive approach encompasses various assessments to provide a holistic evaluation of the interventions' effectiveness in improving outcomes for hospitalized older adults with severe functional dependency.
Overall, this study represents a significant effort to understand how innovative interventions such as cognitive stimulation through IVR and multicomponent physical exercise could positively impact the health outcomes and quality of life of hospitalized older adults with severe functional dependency. The study's findings are expected to provide valuable insights for healthcare providers, researchers, and policymakers seeking to optimize care for this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This clinical randomized controlled trial will be conducted in the Acute Geriatric Unit of a tertiary hospital in Spain. A total of 212 acute patients will be enrolled according to the following criteria: age > 75, Barthel Index < 60, able to collaborate, expected length of stay > 5 days, absence of clinical instability and severe dementia (GDS 7) or other end-stage disease. Patients will be randomly assigned to a control group (CG) or any of the three intervention groups (IG): IVR, ME, or IVR + ME. The IVR group will watch ad-hoc videos showing Spanish regional landscapes and villages, approximately 4 minutes per day for three consecutive days. The ME group will undergo aerobic and strength exercise for progressive training of the upper and lower limbs. The IVR + ME group will do both cognitive and physical intervention. The primary outcomes will be cognitive and physical measures at discharge. Mood, quality of life, isometric strength, and acceptance of IVR will be also assessed.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group |
| immersive virtual reality | Experimental | Device: Virtual realityPatients use virtual reality |
| multicomponent physical exercise intervention | Experimental | Behavioral: multicomponent exerciseIndividualized exercise intervention |
| Immersive virtual reality and multicomponent physical exercise intervention | Experimental | Device: Virtual reality, Behavioral: multicomponent exerciseBoth |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age ≥ 75 years Clinica Stability Expected length of stay ≥ 5 days Being able to communicate and collaborate with the research team
Key exclusion criteria (1 listed)
- Barthel Index score ≥ 60 at admission Refusal to sign the informed consent by the patient/legal guardian or inability to obtain it Life expectancy less than three months End-stage disease Severe level of major neurocognitive disorder (GDS 7)
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 |
|---|---|---|
| Virtual realityImmersive virtual reality | Device | Immersive virtual reality and multicomponent physical exercise intervention, immersive virtual reality |
| multicomponent exerciseindividualized exercise | Behavioural | Immersive virtual reality and multicomponent physical exercise intervention, multicomponent physical exercise intervention |
Primary outcome
Mini-Mental State Examination (MMSE)
Time frame: Baseline, day 3, at discharge and 1 month after discharge
Cognitive evolution
1 secondary outcome
Isometric handgrip strength
Time frame: Baseline, day 3, at discharge and 1 month after discharge
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 13 Jan 2025.
- Results publication: PubMed 35077558Cuevas-Lara C, Saez de Asteasu ML, Ramirez-Velez R, Izquierdo M, Zambom-Ferraresi F, Antonanzas-Valencia C, Galbete A, Zambom-Ferraresi F, Martinez-Velilla N. Effects of game-based interventions on functional capacity in acutely hospitalised older adults: results of an open-label non-randomised clinical trial. Age Ageing. 2022 Jan 6;51(1):afab247. doi: 10.1093/ageing/afab247.
- Derived from this study: PubMed 39516806de la Casa-Marin A, Zambom-Ferraresi F, Ferrara MC, Ollo-Martinez I, Galbete A, Gonzalez-Glaria B, Moral-Cuesta D, Marin-Epelde I, Chenhuichen C, Lorente-Escudero M, Molero-de-Avila R, Baztan AG, Zambom-Ferraresi F, Martinez-Velilla N. Effects of immersive virtual reality stimulation and/or multicomponent physical exercise on cognitive and functional performance in hospitalized older patients with severe functional dependency: study protocol for a randomized clinical trial. BMC Geriatr. 2024 Nov 8;24(1):924. doi: 10.1186/s12877-024-05516-x.
- Individual participant dataSharing planned: Yes. The plan to share anonymized data from a randomized clinical trial in response to reasonable requests focuses on ensuring confidentiality and protecting the privacy of participants. This plan includes fully anonymizing the data, creating a detailed data sharing protocol, establishing an independent data review committee, implementing a clear request procedure, requiring confidentiality agreements to be signed by requestors, and applying robust security measures to protect data integrity. The primary goal is to facilitate access to data to promote transparency and scientific advancement while ensuring respect for the privacy and confidentiality of clinical trial participants. It is important to note that data will be shared under reasonable requests.
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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.
Nicolas Martinez-Velilla Dr, PhD principal investigator
Fundación Miguel Servet - Navarrabiomed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and multicomponent exercise in people with Disability Physical and Cognition, run by Fundacion Miguel Servet 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 1 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: looking for participants now, as of the sponsor's last update on 13 Jan 2025. 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 Nicolas Martinez-Velilla Dr, PhD (00 34 848422222, nicolas.martinez.velilla@navarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMSE) (time frame: Baseline, day 3, at discharge and 1 month after discharge). 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 NCT06340282, which also lists 2 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 13 Jan 2025.