Exercise Intensity and Balance Training for Spinocerebellar Ataxia

(PRIME-Ataxia Trial)

Overseen By Jehan Alomar, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Teachers College, Columbia University

Disqualifiers: Severe motor symptoms, Sensory loss, Visual complications, Musculoskeletal injury, Cerebellum disease, others

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

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how different exercise routines might benefit people with spinocerebellar ataxias (SCAs), a condition affecting coordination and balance. Participants will engage in either high-intensity or low-intensity aerobic exercise followed by balance training, all conducted via telehealth over eight weeks. Researchers aim to determine which approach is more effective and to explore how these exercises impact the learning of new motor skills. Individuals with a confirmed diagnosis of SCA1, 2, 3, 6, or 7 who can walk with or without assistance may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to enhance understanding of how exercise can improve life quality for those with SCAs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on exercise and balance training, so it's best to discuss your medications with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both high-intensity and low-intensity exercises are generally safe for people with cerebellar ataxia. Studies have not reported any serious side effects from these exercise routines. One study on high-intensity aerobic training found that participants who followed a home exercise program experienced no serious issues related to the training. Most participants continued with the program, suggesting that high-intensity aerobic exercise is well-tolerated. Low-intensity exercises have also not shown major safety concerns, making both types of exercise good options for those with cerebellar ataxia who want to improve their balance and movement skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different exercise intensities might enhance balance training for people with spinocerebellar ataxia, a condition that affects coordination and balance. Unlike standard treatments that might focus on medication or physical therapy alone, this trial looks at how high-intensity aerobic exercise can be combined with balance training to potentially improve outcomes. The unique aspect here is investigating whether the intensity of exercise before balance training could make a significant difference in improving balance and coordination, providing a new angle on managing this condition.

What evidence suggests that this trial's treatments could be effective for spinocerebellar ataxia?

This trial will compare high-intensity aerobic exercise before balance training with low-intensity exercise before balance training. Research has shown that high-intensity aerobic exercise can alleviate ataxia symptoms, such as coordination and balance issues. Studies have also found that this exercise can reduce fatigue, likely by promoting brain changes and improving function.

For low-intensity exercise, earlier studies found that participants experienced improved walking and balance after just six weeks of training. Both high and low-intensity exercises offer benefits, with high-intensity exercise being slightly more effective. Overall, both types of exercise can enhance balance and coordination in people with spinocerebellar ataxia. ^{4 6 7 8 9}

Who Is on the Research Team?

Lori Quinn, PT, EdD

Principal Investigator

Teachers College, Columbia University

Chelsea E Macpherson, DPT

Principal Investigator

Teachers College, Columbia University

Are You a Good Fit for This Trial?

This trial is for people aged 18-85 with a confirmed genetic diagnosis of Spinocerebellar Ataxia types SCA1, 2, 3, 6, or 7. Participants should have mild to moderate disease severity and be able to walk with or without help. They need a care partner available during sessions and must not have been doing intense exercise recently.

Inclusion Criteria

My ataxia is mild to moderate, with a SARA score between 8-25.

I can walk, with or without help from a device.

My condition is genetically confirmed as SCA1, 2, 3, 6, or 7.

Exclusion Criteria

My heart or lung condition doesn't limit my ability to exercise.

You have confirmed loss of feeling in your hands or feet.

I have severe vision problems due to my ataxia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including digital posturography and motor task assessments

1 week

2 visits (remote)

Treatment

Participants receive an 8-week telehealth intervention of either high or low intensity exercise followed by balance training

8 weeks

Weekly remote sessions

Mid-Intervention Assessment

Participants undergo a mid-intervention assessment to evaluate progress

1 week

1 visit (remote)

Post-Intervention Assessment

Participants undergo post-intervention assessments including digital posturography and motor task assessments

1 week

1 visit (remote), 1 visit (in-person for a subset)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-Intensity Aerobic Exercise Prior to Balance Training
• Low-Intensity Exercise Prior to Balance Training

Trial Overview The PRIME-Ataxia study tests if high-intensity aerobic exercise before balance training is more effective than low-intensity exercise for the same purpose in individuals with SCAs. This telehealth program runs for eight weeks and includes an assessment of motor skill learning.

How Is the Trial Designed?

Group I: Group 1 Experimental Treatment 1 Intervention

High-Intensity Aerobic Exercise Prior to Balance Training

Group II: Group 2 Active Control 1 Intervention

Low-Intensity Exercise Prior to Balance Training

Who Is Running the Clinical Trial?

Teachers College, Columbia University

Lead Sponsor

Trials

27

Recruited

6,100+

Published Research Related to This Trial

High intensity training (HIT) is safe and well-tolerated by individuals with multiple sclerosis (MS), showing significant improvements in walking speed and endurance based on a review of 13 studies involving 375 participants.

While HIT demonstrates benefits for certain functional outcomes like walking, the variability in training protocols and exercise types means more research is needed to draw definitive conclusions about its overall effectiveness on balance and mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High intensity exercise training on functional outcomes in persons with multiple sclerosis: A systematic review. Bae, M., Kasser, SL.[2023]

Rehabilitation interventions for spinocerebellar ataxia showed significant improvements in balance and gait, with statistical significance for posture (P<.008) and gait (P<.02).

The interventions also led to notable reductions in speech disorders (P=.02), depressive symptoms (P<.0001), and accidental falls (P<.005), indicating a broader impact on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of physical rehabilitation in patients with hereditary spinocerebellar ataxia. A systematic review]. Marchal-Muñoz, A., García-Aranda, M., Marchal-Muñoz, M., et al.[2021]

A review of 20 studies on non-aerobic exercise interventions for improving balance and gait in individuals with mild-to-moderate traumatic brain injury (TBI) found limited evidence of effectiveness, highlighting the need for better quality research.

The studies reviewed often had small sample sizes and varied methodologies, indicating that future research should focus on standardizing interventions and outcome measures to provide clearer insights into their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of physical therapy for improving gait and balance in individuals with traumatic brain injury: a systematic review. Bland, DC., Zampieri, C., Damiano, DL.[2021]

Citations

1. jamanetwork.com jamanetwork.com/journals/neu/fullarticle/10.1001/jamaneurol.2025.3421?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamaneurol.2025.3421

Home Training for Cerebellar Ataxias: A Randomized ... This randomized clinical trial compares home high-intensity aerobic training to home balance training for improvements of ataxia symptoms among.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05826171

Priming Motor Learning Through Exercise in People With ... PRIME-Ataxia is a randomized controlled trial that aims to determine the feasibility and efficacy of an 8-week telehealth intervention of high intensity ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pri.70068

A Randomized Clinical Trial Comparing the Effectiveness ... The aerobic intervention was found only marginally superior to the circuit training, while both were helpful for improving balance in ataxia.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40946705/

Home Training for Cerebellar Ataxias: A Randomized Clinical ... Conclusions and relevance: In this randomized clinical trial, home high-intensity aerobic training improved ataxia symptoms, fatigue, and ...

5. clinicaltrial.be clinicaltrial.be/en/details/419558?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Use of a New Smartphone Application to Determine ... The investigators hypothesize that aerobic training causes improvements for people with spinocerebellar ataxias by inducing neuroplastic changes ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03745248

Aerobic Exercise, Balance Training, and Ataxia The main objective of this project will be to compare the benefits of aerobic versus balance training in DCD. The investigators hypothesize that both aerobic ...

7. jamanetwork.com jamanetwork.com/journals/jamaneurology/article-abstract/2838884

Home Training for Cerebellar Ataxias Conclusions and Relevance In this randomized clinical trial, home high-intensity aerobic training improved ataxia symptoms, fatigue, and aerobic ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8932090/

Home Aerobic Training for Cerebellar Degenerative ... Thirty-one participants completed the trial, and there were no training-related serious adverse events. Compliance to training was over 70%.

9. withpower.com withpower.com/trial/phase-ataxia-1-2023-59f81

Exercise Intensity and Balance Training for ... Research shows that both aerobic and balance training are generally safe for people with cerebellar ataxia, with no serious adverse events reported.