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Virtual Reality Training to Increase Rehabilitative Exercise in Seniors

Primary Purpose

Old Age; Debility, Aging

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
Bruyere Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Old Age; Debility focused on measuring rehabilitation, virtual reality, telerehabilitation, technology

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • York Care Centre
  • Windsor Court
  • Brunswick Hall Special Care Home
  • Orchard View Long Term Care Home
  • Loch Lomond Villa
  • Nashwaak Villa
  • Carleton Manor Nursing Home

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality

Usual Care

Arm Description

Participants receive 8 weeks of home-based or facility-based virtual reality training, supervised remotely and asynchronously, in addition to their usual activity.

Participants perform their usual activities.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functional Reach Test
Measures stability by measuring the maximum distance one can reach forward. Longer distance is better.
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)
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)
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.
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.
Five Times Sit to Stand
Measures lower extremity strength by timing how long it takes to stand then sit 5 times. Lower time better.
Five Times Sit to Stand
Measures lower extremity strength by timing how long it takes to stand then sit 5 times. Lower time better.
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.
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.
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.
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.
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.
Falls
Number of falls
Falls
Number of falls
Emergency Room Visits
Number of emergency room visits
Emergency Room Visits
Number of emergency room visits
Hospital Admissions
Number of admissions to hospital
Hospital Admissions
Number of admissions to hospital
Long-term Care Admissions
Number of admissions to long-term care
Long-term Care Admissions
Number of admissions to long-term care
Utilization of Virtual Reality - Days
Number of days VR was used
Utilization of Virtual Reality - Minutes
Average number of minutes VR was used during each session

Full Information

First Posted
September 5, 2019
Last Updated
January 31, 2023
Sponsor
Bruyere Research Institute
Collaborators
York Care Centre, Carleton Manor Nursing Home, Centre for Innovation and Research in Aging, Canada, Nashwaak Villa, Brunswick Hall, Loch Lomond Villa, Windsor Court Retirement Residence, Orchard View Long Term Care Home
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1. Study Identification

Unique Protocol Identification Number
NCT04083885
Brief Title
Virtual Reality Training to Increase Rehabilitative Exercise in Seniors
Official Title
Home-based and Residence-based Virtual Reality Training to Increase Rehabilitative Exercise in Seniors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
December 8, 2022 (Actual)
Study Completion Date
January 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bruyere Research Institute
Collaborators
York Care Centre, Carleton Manor Nursing Home, Centre for Innovation and Research in Aging, Canada, Nashwaak Villa, Brunswick Hall, Loch Lomond Villa, Windsor Court Retirement Residence, Orchard View Long Term Care Home

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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.
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: To assess the impact of adding home-based VR exercise to usual activity of community-based residents. To assess the impact of adding facility-based VR exercise to usual activity of residents living in long-term care. Objectives: To assess the impact of 8 weeks of home-based VR as an addition to usual activity on: balance, physical function, community integration and quality of life; number of falls, number of emergency room visits, hospital admissions and long-term care admissions; acceptance of VR for exercise. To assess the impact of 8 weeks of facility-based VR as an addition to usual activity of residents in long-term care on: balance, physical function and quality of life; number of falls, number of emergency room visits, hospital admissions; 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. B) 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. A) 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. B) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Old Age; Debility, Aging
Keywords
rehabilitation, virtual reality, telerehabilitation, technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multi-site Prospective randomized open blinded end-point (PROBE) study
Masking
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.
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Participants receive 8 weeks of home-based or facility-based virtual reality training, supervised remotely and asynchronously, in addition to their usual activity.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants perform their usual activities.
Intervention Type
Other
Intervention Name(s)
Virtual Reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional Reach Test
Description
Measures stability by measuring the maximum distance one can reach forward. Longer distance is better.
Time Frame
Change from baseline to immediately after 8-week intervention
Secondary Outcome Measure Information:
Title
Functional Reach Test
Description
Measures stability by measuring the maximum distance one can reach forward. Longer distance is better.
Time Frame
Change from immediately after 8-week intervention to 1 month later
Title
Berg Balance Scale
Description
Measures standing balance and physical function;14 items scored from 0-4 summed for a total out of 56 (higher is better)
Time Frame
Change from baseline to immediately after 8-week intervention
Title
Berg Balance Scale
Description
Measures standing balance and physical function;14 items scored from 0-4 summed for a total out of 56 (higher is better)
Time Frame
Change from immediately after 8-week intervention to 1 month later
Title
Timed Up and Go
Description
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.
Time Frame
Change from baseline to immediately after 8-week intervention
Title
Timed Up and Go
Description
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.
Time Frame
Change from immediately after 8-week intervention to 1 month later
Title
Five Times Sit to Stand
Description
Measures lower extremity strength by timing how long it takes to stand then sit 5 times. Lower time better.
Time Frame
Change from baseline to immediately after 8-week intervention
Title
Five Times Sit to Stand
Description
Measures lower extremity strength by timing how long it takes to stand then sit 5 times. Lower time better.
Time Frame
Change from immediately after 8-week intervention to 1 month later
Title
Frenchay Activities Index
Description
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.
Time Frame
Change from baseline to immediately after 8-week intervention
Title
Frenchay Activities Index
Description
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.
Time Frame
Change from immediately after 8-week intervention to 1 month later
Title
Medical Outcomes Study Short Form 36 (SF-36)
Description
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.
Time Frame
Change from baseline to immediately after 8-week intervention
Title
Medical Outcomes Study Short Form 36 (SF-36)
Description
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.
Time Frame
Change from immediately after 8-week intervention to 1 month later
Title
Feasibility of Virtual Reality
Description
Semi-structured Participant and Study Partner Questionnaire interview on enjoyment, perceived usefulness and acceptance of virtual reality, and interest to continue using VR.
Time Frame
Immediately after 8-week intervention
Title
Falls
Description
Number of falls
Time Frame
Measured during 8-week intervention
Title
Falls
Description
Number of falls
Time Frame
Measured during 1-month post-intervention phase
Title
Emergency Room Visits
Description
Number of emergency room visits
Time Frame
Measured during 8-week intervention
Title
Emergency Room Visits
Description
Number of emergency room visits
Time Frame
Measured during 1-month post-intervention phase
Title
Hospital Admissions
Description
Number of admissions to hospital
Time Frame
Measured during 8-week intervention
Title
Hospital Admissions
Description
Number of admissions to hospital
Time Frame
Measured during 1-month post-intervention phase
Title
Long-term Care Admissions
Description
Number of admissions to long-term care
Time Frame
Measured during 8-week intervention
Title
Long-term Care Admissions
Description
Number of admissions to long-term care
Time Frame
Measured during 1-month post-intervention phase
Title
Utilization of Virtual Reality - Days
Description
Number of days VR was used
Time Frame
Measured during 8-week intervention
Title
Utilization of Virtual Reality - Minutes
Description
Average number of minutes VR was used during each session
Time Frame
Measured during 8-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.). Exclusion Criteria: Patients will be excluded if they have an unstable medical condition, seizures or vertigo.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Sheehy, PhD
Organizational Affiliation
Bruyere Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Justine Henry, MSc
Organizational Affiliation
Centre for Innovation and Research in Aging, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
York Care Centre
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3A 1A3
Country
Canada
Facility Name
Windsor Court
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3A 5S3
Country
Canada
Facility Name
Brunswick Hall Special Care Home
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 0K4
Country
Canada
Facility Name
Orchard View Long Term Care Home
City
Gagetown
State/Province
New Brunswick
ZIP/Postal Code
E5M 1J6
Country
Canada
Facility Name
Loch Lomond Villa
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2J 3S3
Country
Canada
Facility Name
Nashwaak Villa
City
Stanley
State/Province
New Brunswick
ZIP/Postal Code
E6B 1E9
Country
Canada
Facility Name
Carleton Manor Nursing Home
City
Woodstock
State/Province
New Brunswick
ZIP/Postal Code
E7M 5G6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31174579
Citation
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.
Results Reference
background
Citation
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.
Results Reference
result
Links:
URL
https://www.bruyere.org/en/about-bri
Description
Bruyere Research Institute
URL
https://agingresearch.ca/
Description
Centre for Innovation and Research in Aging

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Virtual Reality Training to Increase Rehabilitative Exercise in Seniors

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