Virtual Reality Training to Increase Rehabilitative Exercise in Seniors

Sponsor
Bruyere Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04083885
Collaborator
York Care Centre (Other), New Brunswick Extra-Mural Program (Other), Bayshore HealthCare (Other), Rocmaura Nursing Home (Other), Carleton Manor Nursing Home (Other), Centre for Innovation and Research in Aging, Canada (Other), Nashwaak Villa (Other)
108
5
2
39.9
21.6
0.5

Study Details

Study Description

Brief 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. 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 are eligible for Extra-Mural rehabilitation for mobility issues or 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 Extra-Mural rehabilitation or usual activity (control) or usual Extra-Mural rehabilitation/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 times a week for 8 weeks. Mobility (balance, gait, physical function), and health outcomes (falls, hospital admissions) will be assessed and compared over time.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual Reality
N/A

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 the rehabilitation programs of clients receiving home-care rehabilitation services, or to usual activity.

  2. To assess the impact of adding facility-based VR exercise to the rehabilitation programs of residents receiving rehabilitation services or maintenance for physical conditioning in long-term care, or to usual activity.

Objectives:
  1. To assess the impact of 8 weeks of home-based VR as an addition to home-care rehabilitation or 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 the rehabilitation and maintenance programs 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 homecare rehabilitation or usual activity, compared to homecare rehabilitation or usual activity only, for participants living independently in their homes.

  1. Multi-site randomized controlled trial studying the addition of facility-based VR to homecare rehabilitation or usual activity, compared to homecare rehabilitation or 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 home or at the Centre for Innovation and Research on Aging (CIRA). The Research Therapist (RT) will assess the participant's 10 foot 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 or usual activities.

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 Extra-Mural 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 (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 10 foot 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 Extra-Mural 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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Multi-site Prospective randomized open blinded end-point (PROBE) studyMulti-site Prospective randomized open blinded end-point (PROBE) study
Masking:
Single (Outcomes Assessor)
Masking Description:
The outcomes assessor will not know which arm the participants are in. Group allocation will be provided to the research staff member providing the intervention, through use of an online randomization program.
Primary Purpose:
Treatment
Official Title:
Home-based and Residence-based Virtual Reality Training to Increase Rehabilitative Exercise in Seniors
Actual Study Start Date :
Dec 2, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual Reality

Participants receive 8 weeks of home-based or facility-based virtual reality training, supervised remotely and asynchronously, in addition to their Extra-Mural (homecare) rehabilitation.

Other: Virtual Reality
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. Sessions will be 20-30 minutes long, depending on tolerance.

No Intervention: Usual Care

Participants receive their usual Extra-Mural (homecare) rehabilitation or usual activities.

Outcome Measures

Primary Outcome Measures

  1. Functional Reach Test [Change from baseline to immediately after 8-week intervention]

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

Secondary Outcome Measures

  1. Functional Reach Test [Change from immediately after 8-week intervention to 1 month later]

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

  2. Berg Balance Scale [Change from baseline to immediately after 8-week intervention]

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

  3. Berg Balance Scale [Change from immediately after 8-week intervention to 1 month later]

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

  4. Timed Up and Go [Change from baseline to immediately after 8-week intervention]

    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 7's from 99)) Lower time is better.

  5. Timed Up and Go [Change from immediately after 8-week intervention to 1 month later]

    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 7's from 99)) Lower time is better.

  6. Five Times Sit to Stand [Change from baseline to immediately after 8-week intervention]

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

  7. Five Times Sit to Stand [Change from immediately after 8-week intervention to 1 month later]

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

  8. Frenchay Activities Index [Change from baseline to immediately after 8-week intervention]

    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.

  9. Frenchay Activities Index [Change from immediately after 8-week intervention to 1 month later]

    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.

  10. Medical Outcomes Study Short Form 36 (SF-36) [Change from baseline to immediately after 8-week intervention]

    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.

  11. Medical Outcomes Study Short Form 36 (SF-36) [Change from immediately after 8-week intervention to 1 month later]

    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.

  12. Feasibility of Virtual Reality [Immediately after 8-week intervention]

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

  13. Falls [Measured during 8-week intervention]

    Number of falls

  14. Falls [Measured during 1-month post-intervention phase]

    Number of falls

  15. Emergency Room Visits [Measured during 8-week intervention]

    Number of emergency room visits

  16. Emergency Room Visits [Measured during 1-month post-intervention phase]

    Number of emergency room visits

  17. Hospital Admissions [Measured during 8-week intervention]

    Number of admissions to hospital

  18. Hospital Admissions [Measured during 1-month post-intervention phase]

    Number of admissions to hospital

  19. Long-term Care Admissions [Measured during 8-week intervention]

    Number of admissions to long-term care

  20. Long-term Care Admissions [Measured during 1-month post-intervention phase]

    Number of admissions to long-term care

  21. Utilization of Virtual Reality - Days [Measured during 8-week intervention]

    Number of days VR was used

  22. Utilization of Virtual Reality - Minutes [Measured during 8-week intervention]

    Average number of minutes VR was used during each session

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Home-based VR - Eligible are seniors (=> 65 years old) receiving Extra-Mural rehabilitation for mobility issues, 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 project 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, provided by Extra-Mural therapists and administered by rehabilitation assistants and recreation therapists, 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.).

Exclusion Criteria:

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 York Care Centre Fredericton New Brunswick Canada E3A 1A3
2 Windsor Court Fredericton New Brunswick Canada E3A 5S3
3 Rocmaura Nursing Home Saint John New Brunswick Canada E2K 4P1
4 Nashwaak Villa Stanley New Brunswick Canada E6B 1E9
5 Carleton Manor Nursing Home Woodstock New Brunswick Canada E7M 5G6

Sponsors and Collaborators

  • Bruyere Research Institute
  • York Care Centre
  • New Brunswick Extra-Mural Program
  • Bayshore HealthCare
  • Rocmaura Nursing Home
  • Carleton Manor Nursing Home
  • Centre for Innovation and Research in Aging, Canada
  • Nashwaak Villa

Investigators

  • Principal Investigator: Lisa Sheehy, PhD, Bruyere Research Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Lisa Sheehy, Research Associate, Bruyere Research Institute
ClinicalTrials.gov Identifier:
NCT04083885
Other Study ID Numbers:
  • M16-19-026
First Posted:
Sep 10, 2019
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lisa Sheehy, Research Associate, Bruyere Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2022