Seated Exercise for Neurological Disorders

(Telex Trial)

Overseen By Kathleen Friel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Burke Medical Research Institute

Disqualifiers: Cognitive impairment, Medical issues, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

To assess the impact of a 12-week virtual seated physical intervention on cardiovascular health and wellness in people with chronic neurological impairments (CNI).

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Seated exercise for neurological disorders?

Research suggests that exercise, including seated exercise, can help people with neurological disorders by improving physical activity levels and promoting recovery. Moving limbs, even passively, can help form new brain connections, which may aid in functional recovery after brain injury. ^{1 2 3 4 5}

Is seated exercise generally safe for people with neurological disorders?

Seated exercises are considered a safe alternative to traditional exercises for people with stroke, and the risk-to-benefit ratio favors recommending exercise for those with stroke or spinal cord injury, especially when supervised. However, the evidence on adverse events is limited, and significant risks may exist for unsupervised exercise in certain conditions. ^{6 7 8 9 10}

How is seated exercise different from other treatments for neurological disorders?

Seated exercise is unique because it provides a safe and accessible way for individuals with neurological disorders to engage in physical activity without the need for weight-bearing exercises, which can be challenging for this population. It focuses on improving balance, mobility, and cardiometabolic health, and can be done virtually, making it more accessible for those with limited mobility or access to traditional exercise facilities. ^{3 6 11 12 13}

Research Team

Kathleen Friel

Principal Investigator

Burke Medical Research Institute

Eligibility Criteria

This trial is for adults aged 18-75 with chronic neurological impairments like stroke, multiple sclerosis, or cerebral palsy. They must be stable medically and cognitively, able to use Zoom and a heart rate monitor independently (or have help), speak English, and not exercise more than twice a week. Medical clearance is required.

Inclusion Criteria

I am mentally and physically stable with no serious health issues.

I have a doctor's approval to join this program.

You can exercise without any health problems that would make it unsafe for you.

Exclusion Criteria

I do not have any cognitive impairments that prevent me from safely participating.

You have other health issues that may make it unsafe for you to exercise at home without someone to help you.

Medical issues preventing safe participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Virtual visits via Zoom and Redcap

Treatment

Participants engage in a 12-week virtual seated physical intervention to assess cardiovascular health and wellness

12 weeks

3 virtual sessions per week

Follow-up

Participants are monitored for changes in heart rate and wellness measures after the intervention

1 week

Virtual assessment

Treatment Details

Interventions

• Seated exercise

Trial Overview The study tests the effects of a 12-week home-based seated exercise program delivered virtually on cardiovascular health in people with long-term (>6 months) neurological conditions. Participants will maintain their usual physical activity levels during the trial.

Participant Groups

Group I: Live zoom exercise classes Experimental Treatment 1 Intervention

Participants will engage in a live zoom exercise session. Participants will undergo 45 minutes of aerobic exercise intervention, three times a week, for a period of 12 weeks. Exercise will include repetitive bouts of high intensity exercises with intermittent periods of rest or active recovery. circuit of moves like 'jabs', 'hooks' etc, and a strength and endurance class that promotes postural awareness.

Group II: Recorded zoom exercise classes Active Control 1 Intervention

Participants will undergo 45 minutes of aerobic exercise intervention, three times a week, for a period of 12 weeks, using a pre-recorded class that they can do according to their own schedule. Exercise will include repetitive bouts of high intensity exercises with intermittent periods of rest or active recovery. circuit of moves like 'jabs', 'hooks' etc, and a strength and endurance class that promotes postural awareness.

Who Is Running the Clinical Trial?

Burke Medical Research Institute

Lead Sponsor

Trials

24

Recruited

1,500+

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]

Exercise, particularly aerobic conditioning, is emerging as a crucial therapeutic approach to improve function and cardiovascular health in stroke survivors, addressing both neurological deficits and physical deconditioning.

While there is promising evidence for the benefits of exercise post-stroke, key questions remain about the optimal intensity and prescription of exercise to maximize its effectiveness and prevent future strokes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise rehabilitation after stroke. Ivey, FM., Hafer-Macko, CE., Macko, RF.[2018]

A systematic review of 38 studies involving exercise in adults with spinal cord injury found no serious adverse events (AEs) associated with cardiovascular exercise, suggesting it is safe when following guidelines.

The only notable AEs were musculoskeletal issues related to functional electrical stimulation (FES) walking, while volitional exercise showed very few AEs, indicating that exercise can be beneficial for individuals with spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in cardiovascular-related training programs in people with spinal cord injury: a systematic review. Warms, CA., Backus, D., Rajan, S., et al.[2021]

A review of 36 studies involving 730 stroke participants and 143 with spinal cord injury found that while exercise has clear benefits for improving physical function, the safety of exercise participation remains uncertain due to a lack of studies specifically designed to track adverse events.

Despite concerns about potential risks, the overall risk-to-benefit ratio favors recommending exercise, especially in supervised settings where participants are screened for safety, although significant contraindications exist for unsupervised exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: stroke and spinal cord injury. Zehr, EP.[2016]

In a study of 200 patients with moderate to severe subacute stroke, those who underwent aerobic training experienced a higher rate of serious adverse events compared to those in the relaxation control group, with an incident rate ratio of 1.70.

The occurrence of serious adverse events in the aerobic training group was significantly influenced by pre-existing conditions such as diabetes mellitus and atrial fibrillation, indicating that these factors may increase risk and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial. Rackoll, T., Nave, AH., Ebinger, M., et al.[2022]

References

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

Special considerations for mobilizing patients in the neurointensive care unit. [2012]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Effects of a 12-week, seated, virtual, home-based tele-exercise programme compared with a prerecorded video-based exercise programme in people with chronic neurological impairments: protocol for a randomised controlled trial. [2023]

4. Brazil pubmed.ncbi.nlm.nih.gov

Measurement properties and feasibility of clinical tests to assess sit-to-stand/stand-to-sit tasks in subjects with neurological disease: a systematic review. [2023]

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

Exercise rehabilitation after stroke. [2018]

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

The influence of seated exercises on balance, mobility, and cardiometabolic health outcomes in individuals living with a stroke: A systematic review and meta-analysis. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Adverse events in cardiovascular-related training programs in people with spinal cord injury: a systematic review. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: stroke and spinal cord injury. [2016]

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

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Breaking up sitting time after stroke - How much less sitting is needed to improve blood pressure after stroke (BUST-BP-Dose): Protocol for a dose-finding study. [2020]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A retrospective evaluation of the Brain and Body Fitness Studio service on functional capacity and quality of life in people with neurological disorders. [2023]

12. Australia pubmed.ncbi.nlm.nih.gov

Sitting training early after stroke improves sitting ability and quality and carries over to standing up but not to walking: a randomised trial. [2022]

13. Japan pubmed.ncbi.nlm.nih.gov

Therapeutic physical exercise in neural injury: friend or foe? [2020]