Clinical trial NCT04083885: 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
Overall status: COMPLETED
Phase: NA
Conditions: Old Age; Debility
Aging
Keywords: rehabilitation
virtual reality
telerehabilitation
technology
Lead sponsor: Bruyere Research Institute
Sponsor class: OTHER
Collaborators: name: York Care Centre
name: Carleton Manor Nursing Home
name: Centre for Innovation and Research in Aging, Canada
name: Nashwaak Villa
name: Brunswick Hall
name: Loch Lomond Villa
name: Windsor Court Retirement Residence
name: Orchard View Long Term Care Home
First posted: 2019-09-10
Enrollment: 47
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-site Prospective randomized open blinded end-point (PROBE) study
Primary purpose: TREATMENT

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:

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:

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

   1. balance, physical function and quality of life;
   2. number of falls, number of emergency room visits, hospital admissions;
   3. 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.

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.

Primary outcomes:
measure: Functional Reach Test
timeFrame: Change from baseline to immediately after 8-week intervention
Secondary outcomes:
measure: Functional Reach Test
timeFrame: Change from immediately after 8-week intervention to 1 month later
measure: Berg Balance Scale
timeFrame: Change from baseline to immediately after 8-week intervention
measure: Berg Balance Scale
timeFrame: Change from immediately after 8-week intervention to 1 month later
measure: Timed Up and Go
timeFrame: Change from baseline to immediately after 8-week intervention
measure: Timed Up and Go
timeFrame: Change from immediately after 8-week intervention to 1 month later
measure: Five Times Sit to Stand
timeFrame: Change from baseline to immediately after 8-week intervention
measure: Five Times Sit to Stand
timeFrame: Change from immediately after 8-week intervention to 1 month later
measure: Frenchay Activities Index
timeFrame: Change from baseline to immediately after 8-week intervention
measure: Frenchay Activities Index
timeFrame: Change from immediately after 8-week intervention to 1 month later
measure: Medical Outcomes Study Short Form 36 (SF-36)
timeFrame: Change from baseline to immediately after 8-week intervention
measure: Medical Outcomes Study Short Form 36 (SF-36)
timeFrame: Change from immediately after 8-week intervention to 1 month later
measure: Feasibility of Virtual Reality
timeFrame: Immediately after 8-week intervention
measure: Falls
timeFrame: Measured during 8-week intervention
measure: Falls
timeFrame: Measured during 1-month post-intervention phase
measure: Emergency Room Visits
timeFrame: Measured during 8-week intervention
measure: Emergency Room Visits
timeFrame: Measured during 1-month post-intervention phase
measure: Hospital Admissions
timeFrame: Measured during 8-week intervention
measure: Hospital Admissions
timeFrame: Measured during 1-month post-intervention phase
measure: Long-term Care Admissions
timeFrame: Measured during 8-week intervention
measure: Long-term Care Admissions
timeFrame: Measured during 1-month post-intervention phase
measure: Utilization of Virtual Reality - Days
timeFrame: Measured during 8-week intervention
measure: Utilization of Virtual Reality - Minutes
timeFrame: Measured during 8-week intervention
Other outcomes:
Locations:
city: Fredericton
country: Canada
facility: York Care Centre
state: New Brunswick
city: Fredericton
country: Canada
facility: Windsor Court
state: New Brunswick
city: Fredericton
country: Canada
facility: Brunswick Hall Special Care Home
state: New Brunswick
city: Gagetown
country: Canada
facility: Orchard View Long Term Care Home
state: New Brunswick
city: Saint John
country: Canada
facility: Loch Lomond Villa
state: New Brunswick
city: Stanley
country: Canada
facility: Nashwaak Villa
state: New Brunswick
city: Woodstock
country: Canada
facility: Carleton Manor Nursing Home
state: New Brunswick
Study officials:
affiliation: Bruyere Research Institute
name: Lisa Sheehy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Innovation and Research in Aging, Canada
name: Justine Henry, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.