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Cardiac Output and Fatigue in Friedreich's Ataxia

RecruitingNAAges any - anyAllScott Barbuto
NCT07444333 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a clinical trial examining to impact of aerobic training plus omaveloxolone in FRDA. Thirty individuals with FRDA will be recruited; 20 individuals will be on omaveloxolone treatment whereas the other ten individuals will not. Individuals will undergo baseline assessment including cardiopulmonary exercise testing (CPET), mFARS, gait speed, Timed Up and Go (TUG), Fatigue Severity Scale (FSS), Fatigue Impact Scale (FIS), and 6-minute Walk Test (6MWT). Individuals will then perform 3-months of home aerobic training. Repeat assessments will be conducted at 3- and 6-months.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Genetically confirmed FRDA 2. Ability to safely ride a stationary bicycle (mFARS sitting posture sub-score \<2) Exclusion Criteria: 1. Beck depression score \>19, a score that precludes ability to exercise. 2. Montreal Cognitive Assessment (MoCA) score \<23/30 3. Disorders that interfere with ability to perform endurance exercise (e.g., stroke, respiratory problems, traumatic brain injury, or neuromuscular disease). 4. Regular participation in vigorous endurance exercise (defined as \>2 days/week for at least the past 4 months at max HR\>65%). 5. Evidence of serious arrhythmias or ischemic heart disease.
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What it tests

  • Aerobic Exercise
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Where

1 site
Columbia University Irving Medical Center
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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