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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

Balance and aerobic training show promise as treatments for degenerative cerebellar diseases, but the neural effects of both training methods are unknown. The goal of this project is to evaluate how each training method impacts the brain, and particularly, the degenerating cerebellum. Various neuroimaging techniques will be used to accomplish this goal and test the hypothesis that balance training impacts brain structures outside the cerebellum whereas aerobic training causes more neuroplastic changes within the cerebellum.

Research Team

Scott M Barbuto, MD

Principal Investigator

Assistant Professor of Rehabilitation and Regenerative Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+