What side effects are associated with this type of intervention?

High-intensity aerobic exercise, which is being studied for its potential benefits in Spinocerebellar Ataxias (SCAs), can commonly cause muscle soreness, fatigue, and an increased risk of injury if not performed correctly. Patients with SCAs may also experience exacerbation of symptoms such as coordination difficulties and balance issues, particularly during the initial stages of the exercise program. It is important to tailor the exercise regimen to the individual's capabilities and monitor for any adverse effects closely.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Spinocerebellar Ataxias (SCAs). Current management primarily focuses on symptomatic relief and supportive therapies, including physical therapy, occupational therapy, and speech therapy. High-intensity aerobic exercise, as studied in the PRIME-Ataxia trial, aims to enhance cardiovascular fitness and potentially improve motor function and balance, representing a non-pharmacological approach to managing SCAs.

What other types of research exist?

Promising alternatives to high-intensity aerobic exercise for SCAs patients include virtual reality-guided balance training, which has shown success in improving balance function, and telehealth interventions combining low-intensity exercise with balance training. Additionally, multimodal individualized physical therapy programs, incorporating techniques such as hydrotherapy, music therapy, and sensory-based treatments, may also be beneficial.

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Exercise Intensity and Balance Training for Spinocerebellar Ataxia (PRIME-Ataxia Trial)

N/A

Waitlist Available

Led By Chelsea E Macpherson, DPT

Research Sponsored by Teachers College, Columbia University

Eligibility Criteria Checklist

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

Must have

Scale for Ataxia Rating and Assessment (SARA) score between 8-25/40, capturing mild-moderate disease

Able to walk with/without assistive device

Must not have

Cardiac/pulmonary conditions that would affect participants ability to participate exercise program

Severe visual complications associated with ataxia (i.e., Spontaneous nystagmus, retinal or optic nerve involvement, especially in SCA7) defined as have a score on the Snellen Visual Acuity test = 20/200 - 20/400, OR a visual field of 20 degrees of less.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-intervention (4 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two different online exercise routines for people with spinocerebellar ataxias (SCAs). One routine involves intense cardio workouts before balance exercises, while the other involves light exercises like stretching before balance exercises. The goal is to see which routine better improves balance and motor skills in people with SCAs.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed, typical risks may include muscle soreness, fatigue from high-intensity workouts, increased risk of falls due to balance issues especially post-exercise when fatigued.

Eligibility Criteria

Inclusion Criteria

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

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

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

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

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I am between 18 and 85 years old.

Exclusion Criteria

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

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

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I have severe vision problems due to my ataxia.

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I experience severe movement issues like stiffness, shaking, or Parkinson's symptoms.

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I do not have any injuries that would stop me from exercising.

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I do not have any diseases affecting my cerebellum like stroke or MS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intervention (4 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-intervention (4 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (4 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 Cerebellar Cognitive Affective Syndrome Scale

Change in Patient Reported Outcome Measure for Ataxia

Change in Scale for Assessment and Rating for Ataxia

Secondary study objectives

Acceptability Questionnaire

Activities Specific Balance Scale (ABC)

Digital Biomarker of Dynamic Posturography

+4 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: Group 1Experimental Treatment1 Intervention

High-Intensity Aerobic Exercise Prior to Balance Training

Group II: Group 2Active Control1 Intervention

Low-Intensity Exercise Prior to Balance Training

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Spinocerebellar Ataxias (SCAs) include physical therapy, occupational therapy, and aerobic exercise. High-intensity aerobic exercise, in particular, enhances cardiovascular fitness, which is crucial for overall health and stamina. This type of exercise also potentially improves motor function and balance by promoting neuroplasticity and strengthening the neuromuscular system. For SCA patients, these improvements can lead to better coordination, reduced ataxia symptoms, and an enhanced quality of life, making it a valuable component of their treatment regimen.

Endurance exercise training in a patient with central core disease.Therapeutic effectiveness of a single exercise session combined with WalkAide functional electrical stimulation in post-stroke patients: a crossover design study.A randomized controlled pilot trial of game-based training in individuals with spinocerebellar ataxia type 3.