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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a 12-week seated exercise program can improve heart health and overall wellness in individuals with long-term neurological issues. Participants will either join live Zoom exercise classes or follow pre-recorded sessions, focusing on high-intensity movements with rest breaks. It suits those who have had a neurological impairment for over six months, can remain seated for an hour, and currently exercise two days or less per week. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for many.

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 prior data suggests that this seated exercise intervention is safe for people with chronic neurological impairments?

Research shows that seated exercise programs are generally safe for people with long-term neurological conditions. Studies have found these exercises to be doable and well-received by participants.

For instance, one study reported no serious side effects when participants engaged in a 12-week seated exercise program online. This program included three sessions a week and aimed to boost heart health and overall fitness. Another study confirmed the safety and practicality of these online exercise classes, even though they did not lead to major heart health improvements.

In summary, seated exercise programs are considered safe for people with neurological conditions, with no major safety issues identified in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this seated exercise treatment for neurological disorders because it offers a novel and accessible approach compared to traditional physical therapy or medication. Unlike standard treatments that often require in-person sessions or pharmacological interventions, these seated exercise classes can be accessed live via Zoom or through recorded sessions, allowing flexibility and ease of participation. This method emphasizes aerobic exercise with high-intensity intervals, which could enhance cardiovascular health and postural awareness, potentially leading to improved physical and neurological outcomes. The convenience of participating remotely and the focus on enhancing both strength and endurance make this an appealing option for individuals with mobility challenges.

What evidence suggests that seated exercise is effective for cardiovascular health in people with chronic neurological impairments?

Research has shown that regular aerobic exercise can improve brain function and heart health, even for people with long-term neurological conditions. One study found that high-intensity aerobic exercise helps protect brain cells that produce dopamine, an important brain chemical. Another study showed that doing seated aerobic exercise at home improves heart health for those with chronic neurological issues. Additionally, aerobic exercise links to better mood and thinking skills. In this trial, participants will engage in seated exercise through live Zoom classes or recorded sessions. These approaches may effectively enhance wellness and heart health for individuals with neurological disorders. ^{2 6 7 8 9}

Who Is on the Research Team?

Kathleen Friel

Principal Investigator

Burke Medical Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9256523/

Can exercise shape your brain? A review of aerobic ... This review aims to analyze the effects of regular and acute aerobic exercise on cognition. The exercise-cognition relationship will be reviewed

2. nature.com nature.com/articles/s41598-023-35534-5

Acute aerobic exercise benefits allocation of neural ... The results showed that exercise, relative to the seated rest condition, reduced neural processing of unattended stimuli and increased processing of attended ...

3. medicine.yale.edu medicine.yale.edu/news-article/high-intensity-exercise-can-reverse-neurodegeneration-in-parkinsons-disease/

High-intensity Exercise May Reverse Neurodegeneration in ... Six months of high-intensity aerobic exercise preserves the dopamine-producing neurons in the brain, a small pilot study finds.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11979118/

A seated virtual exercise program to improve ... This study aimed to investigate the effects of a seated home-based tele-exercise regimen on cardiovascular function in adults with chronic neurological ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.862078/full

Aerobic Physical Exercise as a Non-medical Intervention ... Here, this review aimed to reveal that aerobic physical exercise improved depression and several brain functions, including cognitive functions, and provided ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9884574/

Effects of a 12-week, seated, virtual, home-based tele ... This study is a parallel randomised controlled trial to investigate the effects of a 12-week, 3 times/week, seated tele-exercise programme for adults with CNI ( ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04564495

Study Details | NCT04564495 | Home Based Tele-exercise ... This study aims to examine how effective seated Zoom exercise classes are for a person with CNI for addressing cardiovascular health, physical wellness and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2451865423000145

Online neuropilates classes in chronic stroke patients Results from this case study demonstrated that online, remotely supervised neuropilates training is feasible and safe in a one-to-one scenario with a stroke ...

9. researchgate.net researchgate.net/publication/390228976_A_seated_virtual_exercise_program_to_improve_cardiovascular_function_in_adults_with_chronic_neurological_impairments_a_randomized_controlled_trial

(PDF) A seated virtual exercise program to improve ... Conclusion While no significant cardiovascular improvements were observed, the study highlights the feasibility of a virtual, seated exercise ...