Virtual Seated Exercises for Stroke

(V-PASE Trial)

Recruiting at 4 trial locations

Overseen By Chihya Hung, MScPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Formal exercise, Physical activity, Severe vision, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 10 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will determine the acceptability of delivering seated exercises online and if seated exercises can improve balance, mobility, quality of life, and cardiometabolic health in those living with a stroke related mobility impairment. Participants will be allocated to either a 10-week seated exercise program or a delayed 2-week Boot Camp program. All seated exercises sessions and assessments will be conducted virtually.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Virtual Physical Activity Seated Exercises (V-PASE) for stroke patients?

Research shows that various physical activity interventions, including aerobic and resistance training, can improve physical activity levels in stroke patients. These types of exercises, which can be done in both real and virtual environments, have been found to enhance physical function, balance, and quality of life after a stroke. ^{1 2 3 4 5}

Is virtual seated exercise safe for humans?

Research shows that using technology to monitor and deliver seated exercises for stroke survivors is safe, with no reported adverse events. ^{6 7 8 9 10}

How is the Virtual Physical Activity Seated Exercises (V-PASE) treatment different from other treatments for stroke?

V-PASE is unique because it combines virtual reality with seated exercises, making it accessible for individuals with limited mobility after a stroke. This approach can be more engaging and motivating compared to traditional exercises, as it incorporates elements of gaming and virtual environments. ^{4 8 11 12 13}

Eligibility Criteria

This trial is for adults who've had a stroke at least 6 months ago, can stand up from a chair with or without help, and have some mobility issues. They should be able to exercise safely for an hour, speak English, and have access to the internet and email via a computer or tablet.

Inclusion Criteria

I am legally considered an adult in my region.

Able to communicate in English

Have access to a tablet, computer, or laptop with internet and email access

Exclusion Criteria

You have severe problems with your vision, hearing, speaking, or thinking that makes it hard for you to use a computer or talk on video calls.

I have a condition like chronic pain that stops me from doing certain physical activities.

I have a serious health condition like Parkinson's or another active cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to a 10-week seated exercise program or a delayed 2-week Boot Camp program, with sessions conducted virtually

10 weeks

3 virtual sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Delayed Treatment (Boot Camp)

Participants in the delayed group complete a 2-week seated exercise program following the 10-week active trial period

2 weeks

3 virtual sessions per week

Treatment Details

Interventions

• Virtual Physical Activity Seated Exercises (V-PASE)

Trial Overview The study tests if online seated exercises can improve balance, mobility, quality of life, and heart health in those with stroke-related impairments. Participants will either do a 10-week program immediately or join a shorter Boot Camp after.

Participant Groups

Group I: 10-week group Experimental Treatment 1 Intervention

Will receive a 10-week seated exercise program, occurring 3 times per week. Sessions will be 60 minutes in duration.

Group II: Delayed 2-week group (Boot Camp) Active Control 1 Intervention

The Boot Camp group will complete a 2-week seated exercise program following the 10-week active trial period.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Michael Smith Foundation for Health Research

Collaborator

Trials

20

Recruited

6,100+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

Eighteen randomized controlled trials were reviewed, revealing that interventions like aerobic and resistance training, electrical stimulation during walking, and robot-assisted arm therapy significantly increased physical activity in stroke patients.

Despite some effective interventions, the overall quality of evidence was low, and many studies showed no significant differences in physical activity, highlighting the need for more robust research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of interventions aimed at improving physical activity in individuals with stroke: a systematic review. Aguiar, LT., Nadeau, S., Martins, JC., et al.[2021]

Cardiorespiratory training significantly reduces disability in stroke survivors, with a moderate effect size, indicating that such exercise can improve mobility and balance during rehabilitation.

The study found no serious adverse events associated with exercise, suggesting that physical training is a safe intervention for stroke survivors, although it did not influence mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical fitness training for stroke patients. Saunders, DH., Sanderson, M., Hayes, S., et al.[2023]

In a study of 186 stroke survivors, daily ambulatory activity (AA) increased during the subacute phase for those with mild to moderate disabilities, indicating that physical activity is crucial for recovery in this group.

Baseline levels of AA were significantly associated with better functional outcomes (measured by the modified Rankin scale) and quality of life (measured by EQ-5D-3L) at 6 months, highlighting the importance of monitoring and encouraging physical activity after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory activity in stroke survivors associated with functional outcome and quality of life: An observational cohort study. Kaffenberger, T., Bernhardt, J., Koehler, JL., et al.[2022]

This randomized clinical trial will assess the effects of multimodal physical exercises in three different environments (real, virtual, and combined) on post-stroke patients, involving 36 participants over 15 weeks.

The study aims to evaluate improvements in health-related quality of life and various functional capacities, using innovative outcome measures aligned with the International Classification of Functioning, Disability and Health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combination of multimodal physical exercises in real and virtual environments for individuals after chronic stroke: study protocol for a randomized controlled trial. Mazzini, NA., Almeida, MGR., Pompeu, JE., et al.[2020]

A study involving 15 community-dwelling adults with chronic stroke revealed that they conceptualize physical activity (PA) in three main ways: as exercise-related activities, as necessary for daily living tasks, and as a means to avoid sedentary behavior.

Understanding these perceptions of PA can help develop effective interventions to increase physical activity levels post-stroke, which is important for improving overall health and reducing sedentary lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Adults With Stroke Conceptualize Physical Activity: An Exploratory Qualitative Study. Bailey, RR., Stevenson, JL.[2022]

Supervised exercise delivered via telehealth may help stroke survivors increase their physical activity levels, addressing a common barrier to rehabilitation.

This scoping review will systematically gather and analyze evidence on the efficacy, acceptability, safety, and feasibility of telehealth exercise interventions for chronic conditions, particularly focusing on stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised exercise delivered via telehealth in real time to manage chronic conditions in adults: a protocol for a scoping review to inform future research in stroke survivors. Ramage, ER., Fini, NA., Lynch, EA., et al.[2023]

Regular physical activity significantly benefits both primary and secondary stroke prevention by positively influencing various vascular risk factors such as obesity and hypertension.

After a stroke, tailored physical activity can help reduce the risk of recurrence, improve brain function, and enhance quality of life, but it must be adjusted based on individual health conditions and neurological impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Primary and Secondary Stroke Prevention: Physical Activity]. Padlina, G., Scutelnic, A., Salmen, S.[2021]

Using Seated Power Assisted Exercise (PAE) equipment significantly helps individuals recovering from stroke transition from early rehabilitation to long-term recovery, as reported by participants in a qualitative study of 8 stroke survivors.

Participants expressed that PAE not only aids physical recovery but also positively reframes their experience of stroke, suggesting that community-based PAE programs are valuable for ongoing rehabilitation and should be further developed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Users' experience of community-based power assisted exercise: a transition from NHS to third sector services. Young, R., Broom, D., O'Brien, R., et al.[2022]

The study demonstrated that using an internet-based app and chair sensor to monitor and guide home exercises for stroke patients is feasible and safe, with all 10 participants completing the program and exceeding their exercise goals.

Participants reported high satisfaction with the system, and there were no adverse events, suggesting that this technology could effectively support increased exercise adherence and potentially improve physical function after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Connecting patients and therapists remotely using technology is feasible and facilitates exercise adherence after stroke". Simpson, DB., Bird, ML., English, C., et al.[2020]

This longitudinal observational study will track physical activity levels in stroke survivors for 2 years after rehabilitation discharge, aiming to understand how physical activity relates to cardiovascular risk factors and mobility.

The study will include 77 participants and measure various outcomes, such as moderate to vigorous physical activity and cardiovascular health, to identify factors influencing long-term physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the relationship between physical activity and cardiovascular risk factors in stroke survivors post completion of rehabilitation? Protocol for a longitudinal study. Fini, NA., Bernhardt, J., Holland, AE.[2022]

The VirTele intervention, which combines virtual reality exergames with a telerehabilitation app, was found to be a feasible and effective alternative for rehabilitating upper extremity function in chronic stroke survivors, with improvements observed in motor function and motivation compared to conventional therapy.

Despite some technical issues, most participants found the VirTele technology easy to use, and 75% of those in the experimental group showed increased motivation, suggesting that this approach could enhance engagement in rehabilitation activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of Upper Extremity by Telerehabilitation Combined With Exergames in Survivors of Chronic Stroke: Preliminary Findings From a Feasibility Clinical Trial. Allegue, DR., Higgins, J., Sweet, SN., et al.[2022]

Participants with chronic stroke found that video games served as a motivating tool for physical activity rather than traditional treatment, promoting whole-body movement.

The group setting of the video-game intervention fostered a sense of community and support, suggesting that this approach could be a cost-effective way to maintain mobility and prevent inactivity in individuals with chronic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A video-game group intervention: Experiences and perceptions of adults with chronic stroke and their therapists: Intervention de groupe à l'aide de jeux vidéo : Expériences et perceptions d'adultes en phase chronique d'un accident vasculaire cérébral et de leurs ergothérapeutes. Rand, D., Givon, N., Avrech Bar, M.[2018]

Game-based exercise significantly improved hand strength and motor function in stroke patients compared to traditional manual exercises, based on a study involving 50 participants over 6 weeks.

Patients engaging in game-based exercises reported higher levels of motivation and enjoyment, indicating better compliance with the rehabilitation program, without an increase in pain or fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Game-based hand resistance exercise versus traditional manual hand exercises for improving hand strength, motor function, and compliance in stroke patients: A multi-center randomized controlled study. Park, JS., Lee, G., Choi, JB., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of interventions aimed at improving physical activity in individuals with stroke: a systematic review. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Physical fitness training for stroke patients. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Ambulatory activity in stroke survivors associated with functional outcome and quality of life: An observational cohort study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A combination of multimodal physical exercises in real and virtual environments for individuals after chronic stroke: study protocol for a randomized controlled trial. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

How Adults With Stroke Conceptualize Physical Activity: An Exploratory Qualitative Study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Supervised exercise delivered via telehealth in real time to manage chronic conditions in adults: a protocol for a scoping review to inform future research in stroke survivors. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

[Primary and Secondary Stroke Prevention: Physical Activity]. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Users' experience of community-based power assisted exercise: a transition from NHS to third sector services. [2022]

9. England pubmed.ncbi.nlm.nih.gov

"Connecting patients and therapists remotely using technology is feasible and facilitates exercise adherence after stroke". [2020]

10. England pubmed.ncbi.nlm.nih.gov

What is the relationship between physical activity and cardiovascular risk factors in stroke survivors post completion of rehabilitation? Protocol for a longitudinal study. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Rehabilitation of Upper Extremity by Telerehabilitation Combined With Exergames in Survivors of Chronic Stroke: Preliminary Findings From a Feasibility Clinical Trial. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

A video-game group intervention: Experiences and perceptions of adults with chronic stroke and their therapists: Intervention de groupe à l'aide de jeux vidéo : Expériences et perceptions d'adultes en phase chronique d'un accident vasculaire cérébral et de leurs ergothérapeutes. [2018]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Game-based hand resistance exercise versus traditional manual hand exercises for improving hand strength, motor function, and compliance in stroke patients: A multi-center randomized controlled study. [2020]