Exercise Therapy for Cerebellar Ataxia

Overseen By Scott Barbuto, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Other neurologic conditions, heart disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how two types of exercise—balance and aerobic training—affect the brain in individuals with cerebellar ataxia, a condition that impacts coordination and balance. Researchers seek to discover if balance exercises benefit other brain areas, while aerobic exercises (such as biking) specifically aid the cerebellum, which controls movement. The trial seeks participants diagnosed with spinocerebellar ataxia who show cerebellar damage on scans and can safely use a stationary bike. As an unphased trial, this study offers a unique opportunity to enhance understanding of how exercise can improve brain function in cerebellar ataxia.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these training methods are safe for participants?

Research has shown that both aerobic and balance exercises are generally safe for people with cerebellar ataxia. In a previous study, aerobic exercises did not cause any serious health problems. Over 70% of participants continued their exercise routines, indicating manageability. Similarly, balance exercises improved movement without harmful effects. Participants completed these exercises without major issues, highlighting the safety of both methods. Overall, these exercise programs are considered safe and manageable for people with cerebellar ataxia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Exercise therapy for cerebellar ataxia is generating buzz because it's all about using movement to help improve balance and coordination. Unlike typical treatments that might focus on medication or traditional physical therapy, this approach combines aerobic and balance training tailored specifically to each person. Aerobic training uses a stationary bike to enhance cardiovascular fitness, gradually increasing intensity based on individual capacity. Balance training, on the other hand, involves personalized exercises designed to improve stability and motor control through challenging positions and movements. Researchers are excited because these methods could offer a more dynamic and proactive way to manage ataxia symptoms, potentially improving quality of life without the side effects associated with medications.

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

This trial will compare Aerobic Training with Balance Training for individuals with cerebellar ataxia. Research has shown that both aerobic and balance exercises can benefit people with this condition, which affects movement and balance. Participants in the Aerobic Training arm will perform high-intensity aerobic exercises at home. Previous studies have shown these exercises improve symptoms, reduce tiredness, and boost overall fitness. Meanwhile, participants in the Balance Training arm will follow a six-week home program tailored to improve walking and mobility. Studies suggest that balance exercises can be effective for those with ataxia. Both exercise types have shown promise in managing symptoms of cerebellar ataxia. ^{1 3 4 6 7}

Who Is on the Research Team?

Scott M Barbuto, MD

Principal Investigator

Assistant Professor of Rehabilitation and Regenerative Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with degenerative cerebellar diseases who experience ataxia, have cerebellar atrophy visible on MRI, and can safely use a stationary exercise bike. It's not suitable for those with other neurological conditions, medical instability, cognitive impairments, or heart disease.

Inclusion Criteria

I can safely use a stationary exercise bike.

I have been diagnosed with ataxia.

You have cerebellar atrophy as shown on an MRI scan.

Exclusion Criteria

I have difficulty with memory or thinking clearly.

Any other medical conditions related to the nervous system.

Medical instability

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either balance or aerobic training for 6 months

6 months

Weekly contact via email or phone

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Training
• Balance Training

Trial Overview The study is examining the effects of balance and aerobic training on the brain in people with degenerative cerebellar diseases. It aims to determine how these exercises impact brain structure using neuroimaging techniques.

How Is the Trial Designed?

Group I: Aerobic Training Experimental Treatment 1 Intervention

Participants will be given a stationary exercise bike for home use. They will be instructed to use the exercise bike five times a week for thirty-minute sessions. The exercise intensity prescription will be based on the subject's VO2max determined on pre-test day. The exercise program will start at 60% of intensity per session, and then will be increased by steps of 5% intensity every 2 sessions until participants reach 30 minutes of training at 80% intensity. Participants will be contacted weekly by e-mail or phone to answer any questions about the exercise protocol and will be instructed to log each training session. Subjects will record duration of exercise, perceived exertion, average heart rate, maximum heart rate, and distance.

Group II: Balance Training Active Control 1 Intervention

A physical therapist will tailor a home balance training program for each participant based on pre- training capabilities. Subjects will be asked to perform exercises five times a week for thirty-minute sessions. Both dynamic and static exercises will be performed in sitting and standing positions. Exercises will start with stabilizing in a challenging static position and progress to dynamic arm and leg movements in the same or modified position. Participants will be contacted weekly by e-mail or phone to answer any questions about the exercise protocol and will be required to log their exercise effort in terms of frequency and level of balance challenge.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40653445/

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.

2. 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 ...

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

Home Aerobic Training for Cerebellar Degenerative ... This 6-month trial comparing home aerobic versus balance training in cerebellar ataxia had excellent retention and adherence to training.

4. 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.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03745248

Aerobic Exercise, Balance Training, and Ataxia | ... A single study to date has evaluated the benefits of aerobic exercise on DCD in humans, and this was a secondary outcome of the study.

6. 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10543624/

Physical Activity and Fitness Levels of Individuals with Ataxia The importance of physical activity is further supported by recent studies showing that aerobic exercise leads to over a 2-point improvement in SARA scores for ...