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RECRUITING Not applicable ClinicalTrials.gov

Cardiac Output and Fatigue in Friedreich's Ataxia

Sponsor: Scott Barbuto • ClinicalTrials.gov ID: NCT07444333

Registry updated: 2026-09-22
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Description

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.

Interventions

  • Aerobic Exercise (Behavioral)
    Both groups will receive aerobic training. The difference will be whether individuals are on or off omaveloxolone.

Eligibility criteria

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.

Conditions

Friedreich's Ataxia

Locations

  • Columbia University Irving Medical Center — New York, New York, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record