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Old Age; DebilityNCT04083885

Virtual Reality Training to Increase Rehabilitative Exercise in Seniors

A study testing Virtual Reality in people with Old Age; Debility and Aging, run by Bruyère Health Research Institute. at 7 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Seniors are at risk for reduced independence and lowered quality of life after injury or illness. Gains in strength, stamina, balance, cardiovascular fitness and confidence resulting from regular exercise can help seniors to maintain (or improve) their functional ability, independence, and quality of life. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Old Age; Debility, Aging
What is being tested?
Virtual Reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
7 sitesCanada
Study dates
2 Dec 2019to 4 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Home-based VR - Eligible are seniors (=> 65 years old) with reduced mobility or functional decline, or who could benefit from increased rehabilitative exercise. Clients must 1) be able to sit or stand without assist (gait aid is fine) for 20 minutes (rest breaks are fine), 2) have sufficient cognitive ability to perform VR, 3) have a study partner, 4) speak and understand French or English, 5) attend 3 sessions at the assessment site or their own home, 6) have enough space in their home, 7) have no health conditions that preclude mild to moderate exercise, 8) live within 50km of the assessment site.
  • Facility-based VR - Eligible are seniors living in long-term care and receiving rehabilitation or maintenance programs for mobility issues or functional decline, or who could benefit from rehabilitative exercise. Residents must 1) be able to sit or stand without assist (gait aid is fine) for at least 20 minutes (rest breaks are fine), 2) have sufficient cognitive ability to perform VR, 3) speak and understand French or English, 4) have no health conditions that preclude mild exercise, 5) have a study partner (can be a staff member, family member, friend, volunteer etc.).

Who cannot join

  • Patients will be excluded if they have an unstable medical condition, seizures or vertigo.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites
  • York Care Centre

    Fredericton, New Brunswick, E3A 1A3

  • Windsor Court

    Fredericton, New Brunswick, E3A 5S3

  • Brunswick Hall Special Care Home

    Fredericton, New Brunswick, E3B 0K4

  • Orchard View Long Term Care Home

    Gagetown, New Brunswick, E5M 1J6

  • Loch Lomond Villa

    Saint John, New Brunswick, E2J 3S3

  • Nashwaak Villa

    Stanley, New Brunswick, E6B 1E9

  • Carleton Manor Nursing Home

    Woodstock, New Brunswick, E7M 5G6

Other trials in Canada

About this study

Official title: Home-based and Residence-based Virtual Reality Training to Increase Rehabilitative Exercise in Seniors

Seniors are at risk for reduced independence and lowered quality of life after injury or illness. Gains in strength, stamina, balance, cardiovascular fitness and confidence resulting from regular exercise can help seniors to maintain (or improve) their functional ability, independence, and quality of life. However, seniors experience many barriers to exercise. The objective is to assess the use of virtual reality (VR) as a motivating way to encourage seniors to do regular rehabilitative exercise. Seniors who could benefit from rehabilitative exercise and who live in two situations, a) long-term care and b) independently in their homes, will be recruited. Participants will be randomized to usual activity (control) or usual activity plus VR exercise. Long-term care residents will do VR with the assistance of care staff or study partners under the direction of the research team. Independent-living participants will do VR in their homes with the supervision of study partners, under the direction of the research team. All participants will be asked to do VR 3-5 times a week for 8 weeks. Mobility (balance, gait, physical function), and health outcomes (falls, hospital admissions) will be assessed and compared over time.

Read the detailed description

Background and Justification:

Decreased physical conditioning can occur after injury or illness, particularly in seniors. Frail and physically vulnerable seniors have greater risk for loss of independence and lowered quality of life. They are more likely to need long-term residential care. Seniors also have an increased risk of falls, which are the leading cause of injuries and injury-related hospital admissions among older Canadians, accounting for 85% of seniors' injury-related hospitalizations. Further, falls are associated with over 1/3 of admissions to long-term care facilities after release from the hospital. In 2004, the direct cost of falls to seniors in Canada was estimated to be $2 billion; this number will be much higher today, as health-care costs have increased and the number of seniors has increased as well. Among the many risk factors for falls include physical considerations such as balance and gait deficits, muscle weakness \& reduced physical fitness.

Seniors would like to live in their own homes and communities for as long as possible. They also would like to maintain (or improve) their independence, ability to function and quality of life. Gains in strength, stamina, balance, cardiovascular fitness and confidence resulting from regular exercise can help seniors to achieve these goals, reduce the risk of falls and increase social engagement. However, seniors experience many barriers to doing exercise, including a lack of motivation, pain or injury, lack of knowledge, fear of falling, transportation difficulties, no one to exercise with, poor weather and high cost. In fact, only 11% of Canadians between the ages of 60 and 79 meet Canada's physical activity guidelines. For those who live in rural locations, further barriers exist, like isolation, safety (cannot go for a walk on busy highways or dark roads) and lack of access to community-based services.

Virtual reality (VR) is proposed as a motivating and enjoyable way to encourage seniors to do regular rehabilitative exercise, either as part of a home-based rehabilitation plan after injury or illness, or as a part of a plan to enhance mobility and decrease falls in a residential long-term care home.

Goals:

  1. To assess the impact of adding home-based VR exercise to usual activity of community-based residents.
  2. To assess the impact of adding facility-based VR exercise to usual activity of residents living in long-term care.

Objectives:

  1. To assess the impact of 8 weeks of home-based VR as an addition to usual activity on:
  2. balance, physical function, community integration and quality of life;
  3. number of falls, number of emergency room visits, hospital admissions and long-term care admissions;
  4. acceptance of VR for exercise.
  5. To assess the impact of 8 weeks of facility-based VR as an addition to usual activity of residents in long-term care on:
  6. balance, physical function and quality of life;
  7. number of falls, number of emergency room visits, hospital admissions;
  8. acceptance of VR for exercise.

Two separate, but related studies are included; A) Randomized controlled trial studying the addition of home-based VR to usual activity, compared to usual activity only, for participants living independently in their homes.

  1. Multi-site randomized controlled trial studying the addition of facility-based VR to usual activity, compared to usual activity only for participants living in long-term care facilities.
  2. Home-based study participants will undergo a 1-1 1/2 hour physical assessment of balance, gait, physical function, activities of daily living and quality of life, given by the Research Assistant (RA), either in their homes or at the Centre for Innovation and Research on Aging (CIRA). The Research Therapist (RT) will assess the participant's 5 m walk test (used to assess gait speed; Appendix U), then randomize the participant into either the control or experimental groups using an online randomization tool, stratified according to gait speed.

Participants in the control group will be told to continue on as normal with their usual activities.

Participants and study partners in the experimental group will be introduced to the Jintronix VR platform and will discuss with the RT their abilities and therapy goals. The RT will consult with the participant's health care professionals (if appropriate) and create a customized VR program of approximately 20-30 minutes. The RT will then install the VR system in the participant's home and train the participant and study partner on the use of VR. Safety considerations will be reviewed (the study partner is not to assist or guard the participant, just be in the home during VR). A photograph is taken of the set-up, to document that the location is safe, in case the participant re-arranges furniture etc. into an unsafe position.

Participants will be instructed to perform the VR session 3-5 times a week for 8 weeks. The RT will contact the participant (preferably by phone) twice in the first week and at least once a week thereafter, and participants will be invited to contact the RT as needed. The RT will also monitor VR usage remotely. The RT can modify the games remotely as required. Further home visits can be made as required, preferably once during week 2, to assess exercise technique and answer questions.

After 8 weeks, the participant will return to CIRA to be reassessed by the RA and then the VR system will be removed from the home. The first 10 participants in the experimental group (and their study partners) will also provide a 10-minute interview on their experience with VR.

One month later, the participant will return to CIRA for a final reassessment with the RA.

All assessments can be performed in the participant's home rather than having them come to CIRA.

  1. Facility-based study participants will undergo a 1 - 1 ½ hour physical assessment of balance, gait, physical function, activities of daily living and quality of life, given by the Research Assistant (RA). This assessment will be done at the participant's long-term care facility. The Research Therapist (RT) will assess the participant's 5 m walk test (used to assess gait speed; Appendix U), then randomize the participant into either the control or experimental groups using an online randomization tool, stratified according to gait speed.

Participants in the control group will be told to continue on as normal with their Extra-Mural homecare rehabilitation program and/or any other activities that they normally do.

Participants in the experimental group will be introduced to the Jintronix VR platform and will discuss with the RT their abilities and therapy goals. The RT will consult with the participant's health care professionals (if appropriate) and with the facility staff (particularly recreation therapists and rehabilitation assistants), and create a customized VR program of approximately 20-30 minutes.

Rehabilitation assistants and recreation therapists/coordinators working at the long-term care sites will be trained on the use of Jintronix VR during a 2-hour workshop. The rehabilitation assistants or recreation therapists/coordinators will be instructed on each participant's individual program and any safety or technique requirements and will assist and supervise long-term care participants to perform their VR programs. Other study partners (for example, family members or volunteers) may be used as well. Participants will be instructed to perform the VR session 3-5 times a week for 8 weeks. The RT will contact the participant and the rehabilitation assistant or recreation therapist or study partner (preferably in person) twice in the first week and at least once a week thereafter, and participants and rehabilitation assistant/recreation therapist/study partner will be invited to contact the RT as needed. The RT will also monitor VR usage remotely. The RT can modify the games remotely as required.

After 8 weeks, all participants will be reassessed at their long-term care facilities by the RA. The first 10 residents in the experimental group will also provide a 10-minute interview on their experience with VR. One month later, the participant will have a final reassessment with the RA.

Being tested
Virtual Reality
Keywords
rehabilitation, virtual reality, telerehabilitation, technology
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual RealityOther

    Participants will be provided with a virtual reality training program, personalized with respect to their abilities, endurance, needs and treatment goals. They will be trained to use the program and it will be installed in their home or provided at their long-term care facility. Participants will be suggested to perform VR 3-5 times a week for 8 weeks. Sessions will be 20-30 minutes long, depending on tolerance.

Study groups in NCT04083885
Study groupRoleWhat they receive
Virtual RealityExperimentalParticipants receive 8 weeks of home-based or facility-based virtual reality training, supervised remotely and asynchronously, in addition to their usual activity.
Receives: Other: Virtual Reality
Usual CareNo interventionParticipants perform their usual activities.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Reach Test

    Measures stability by measuring the maximum distance one can reach forward. Longer distance is better.

    Measured: Change from baseline to immediately after 8-week intervention

Secondary outcomes (22)
  1. Functional Reach Test

    Measures stability by measuring the maximum distance one can reach forward. Longer distance is better.

    Measured: Change from immediately after 8-week intervention to 1 month later

  2. Berg Balance Scale

    Measures standing balance and physical function;14 items scored from 0-4 summed for a total out of 56 (higher is better)

    Measured: Change from baseline to immediately after 8-week intervention

  3. Berg Balance Scale

    Measures standing balance and physical function;14 items scored from 0-4 summed for a total out of 56 (higher is better)

    Measured: Change from immediately after 8-week intervention to 1 month later

  4. Timed Up and Go

    Measures the time required to rise from a chair, walk 3 m, return and sit down (3 versions, original, manual (carrying a cup of water) and cognitive (count backward in 3's from 99)) Lower time is better.

    Measured: Change from baseline to immediately after 8-week intervention

  5. Timed Up and Go

    Measures the time required to rise from a chair, walk 3 m, return and sit down (3 versions, original, manual (carrying a cup of water) and cognitive (count backward in 3's from 99)) Lower time is better.

    Measured: Change from immediately after 8-week intervention to 1 month later

  6. Five Times Sit to Stand

    Measures lower extremity strength by timing how long it takes to stand then sit 5 times. Lower time better.

    Measured: Change from baseline to immediately after 8-week intervention

  7. Five Times Sit to Stand

    Measures lower extremity strength by timing how long it takes to stand then sit 5 times. Lower time better.

    Measured: Change from immediately after 8-week intervention to 1 month later

  8. Frenchay Activities Index

    Measures the frequency of domestic chores, leisure/work and outdoor activities. Scores 15 items from 0-3, summed for a total score out of 45. Higher is better.

    Measured: Change from baseline to immediately after 8-week intervention

  9. Frenchay Activities Index

    Measures the frequency of domestic chores, leisure/work and outdoor activities. Scores 15 items from 0-3, summed for a total score out of 45. Higher is better.

    Measured: Change from immediately after 8-week intervention to 1 month later

  10. Medical Outcomes Study Short Form 36 (SF-36)

    Patient report of health status and health-related quality of life. Rates 36 items from 1-3, 1-2, 1-5 or 1-6 and uses "rules" to score each out of 100 and averages them in groups to create scores in 8 different categories (ex. energy/fatigue, emotional well-being). Higher is better.

    Measured: Change from baseline to immediately after 8-week intervention

  11. Medical Outcomes Study Short Form 36 (SF-36)

    Patient report of health status and health-related quality of life. Rates 36 items from 1-3, 1-2, 1-5 or 1-6 and uses "rules" to score each out of 100 and averages them in groups to create scores in 8 different categories (ex. energy/fatigue, emotional well-being). Higher is better.

    Measured: Change from immediately after 8-week intervention to 1 month later

  12. Feasibility of Virtual Reality

    Semi-structured Participant and Study Partner Questionnaire interview on enjoyment, perceived usefulness and acceptance of virtual reality, and interest to continue using VR.

    Measured: Immediately after 8-week intervention

  13. Falls

    Number of falls

    Measured: Measured during 8-week intervention

  14. Falls

    Number of falls

    Measured: Measured during 1-month post-intervention phase

  15. Emergency Room Visits

    Number of emergency room visits

    Measured: Measured during 8-week intervention

  16. Emergency Room Visits

    Number of emergency room visits

    Measured: Measured during 1-month post-intervention phase

  17. Hospital Admissions

    Number of admissions to hospital

    Measured: Measured during 8-week intervention

  18. Hospital Admissions

    Number of admissions to hospital

    Measured: Measured during 1-month post-intervention phase

  19. Long-term Care Admissions

    Number of admissions to long-term care

    Measured: Measured during 8-week intervention

  20. Long-term Care Admissions

    Number of admissions to long-term care

    Measured: Measured during 1-month post-intervention phase

  21. Utilization of Virtual Reality - Days

    Number of days VR was used

    Measured: Measured during 8-week intervention

  22. Utilization of Virtual Reality - Minutes

    Average number of minutes VR was used during each session

    Measured: Measured during 8-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2019
  2. Study start2 Dec 2019
  3. Primary completion8 Dec 2022
  4. Study completion4 Jan 2023

Resources

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
Model description
Multi-site Prospective randomized open blinded end-point (PROBE) study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04083885
Sponsor's protocol ID
M16-19-026
Status last verified
Jan 2023
First submitted
5 Sep 2019
Last updated
2 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sheehy L, Taillon-Hobson A, Sveistrup H, Bilodeau M, Yang C, Welch V, Hossain A, Finestone H. Home-based virtual reality training after discharge from hospital-based stroke rehabilitation: a parallel randomized feasibility trial. Trials. 2019 Jun 7;20(1):333. doi: 10.1186/s13063-019-3438-9.

    PubMed 31174579
  • Sheehy L, Chapman I, Sveistrup H, Yang C, Bilodeau M, Finestone H. Home-based virtual reality training after stroke: preliminary data of a telerehabilitation feasibility randomized controlled trial. International Journal of Stroke 13(2S):207, 2018.

  • Sheehy L, Bharadwaj L, Nissen KA, Estey JL. Non-Immersive Virtual Reality Exercise Can Increase Exercise in Older Adults Living in the Community and in Long-Term Care: A Randomized Controlled Trial. Clin Interv Aging. 2025 Feb 5;20:109-124. doi: 10.2147/CIA.S498272. eCollection 2025.

    PubMed 39931102

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality in people with Old Age; Debility and Aging, run by Bruyère Health Research Institute. at 7 sites in Canada.

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 2 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: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Reach Test (time frame: Change from baseline to immediately after 8-week intervention). 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 NCT04083885, 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 2 Feb 2023.

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