NCT04083885

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 2, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2022

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2023

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

September 5, 2019

Last Update Submit

January 31, 2023

Conditions

Keywords

rehabilitationvirtual realitytelerehabilitationtechnology

Outcome Measures

Primary Outcomes (1)

  • Functional Reach Test

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

    Change from baseline to immediately after 8-week intervention

Secondary Outcomes (22)

  • Functional Reach Test

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

  • Berg Balance Scale

    Change from baseline to immediately after 8-week intervention

  • Berg Balance Scale

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

  • Timed Up and Go

    Change from baseline to immediately after 8-week intervention

  • Timed Up and Go

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

  • +17 more secondary outcomes

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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

Other: Virtual Reality

Usual Care

NO INTERVENTION

Participants perform their usual activities.

Interventions

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.

Virtual Reality

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

York Care Centre

Fredericton, New Brunswick, E3A 1A3, Canada

Location

Windsor Court

Fredericton, New Brunswick, E3A 5S3, Canada

Location

Brunswick Hall Special Care Home

Fredericton, New Brunswick, E3B 0K4, Canada

Location

Orchard View Long Term Care Home

Gagetown, New Brunswick, E5M 1J6, Canada

Location

Loch Lomond Villa

Saint John, New Brunswick, E2J 3S3, Canada

Location

Nashwaak Villa

Stanley, New Brunswick, E6B 1E9, Canada

Location

Carleton Manor Nursing Home

Woodstock, New Brunswick, E7M 5G6, Canada

Location

Related Publications (3)

  • 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.

    PMID: 31174579BACKGROUND
  • 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.

    RESULT
  • 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.

Related Links

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lisa Sheehy, PhD

    Bruyère Health Research Institute.

    PRINCIPAL INVESTIGATOR
  • Justine Henry, MSc

    Centre for Innovation and Research in Aging, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multi-site Prospective randomized open blinded end-point (PROBE) study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Affiliate Investigator

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 10, 2019

Study Start

December 2, 2019

Primary Completion

December 8, 2022

Study Completion

January 4, 2023

Last Updated

February 2, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations