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Exercise Therapy for Cerebellar Ataxia

N/A

Waitlist Available

Led By Scott M Barbuto, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to safely ride a stationary exercise bike

Diagnosed with spinocerebellar ataxia

Must not have

Cognitive impairment

Heart disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0,6,9,12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will use neuroimaging techniques to study the effects of balance and aerobic training on the brain, specifically the degenerating cerebellum. The hypothesis is that balance training impacts structures outside the cerebellum while aerobic training affects the cerebellum itself.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed for this type of physical training, participants may experience general exercise-related discomfort such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can safely use a stationary exercise bike.

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I have been diagnosed with spinocerebellar ataxia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have difficulty with memory or thinking clearly.

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I have heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0,6,9,12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0,6,9,12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0,6,9,12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Assessment and Rating of Ataxia (SARA) Score

Secondary study objectives

Average gait speed

Dynamic Gait Index score

Fatigue severity scale

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Aerobic TrainingExperimental Treatment1 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 TrainingActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aerobic Training

2024

N/A

~880

0 / 4Eligibility criteria met