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NCT07444333Recruiting

Cardiac Output and Fatigue in Friedreich's Ataxia

Source: ClinicalTrials.gov · Last updated 22 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
17 Nov 2025
Start date
15 Jul 2026
Primary completion date
1 Feb 2028
Lead sponsor
Scott Barbuto
NCT number
NCT07444333

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 15 Jul 2026 to the primary completion date, 1 Feb 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Disorders that interfere with ability to perform endurance exercise (e.g., stroke, respiratory problems, traumatic brain injury, or neuromuscular disease).
  • Evidence of serious arrhythmias or ischemic heart disease.

Other

  • Beck depression score \>19, a score that precludes ability to exercise.
  • Montreal Cognitive Assessment (MoCA) score \<23/30
  • Regular participation in vigorous endurance exercise (defined as \>2 days/week for at least the past 4 months at max HR\>65%).

Who the study is looking for

  • Genetically confirmed FRDA
  • Ability to safely ride a stationary bicycle (mFARS sitting posture sub-score \<2)

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Columbia University Irving Medical Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.