This study aims to understand whether cardiac output and fatigue are impacted by aerobic exercise with and without the use of omaveloxolone. Participation in the study involves 4 in person assessments at Columbia University at 0, 1, 3, and 6 months. Participants will be provided with a recumbent bike and a FitBit and asked to exercise at home on their bike for 30 minutes 5 times a week for 3 months.
Study assessments include fitness testing on a stationary recumbent bike and tests of balance, gait, and fatigue. Study results will compare individuals taking omaveloxolone to those not taking omaveloxolone to determine the benefit of exercise.
Anyone considering participating in a clinical trial should discuss the matter with their physician. FARA does not endorse or recommend any particular studies.
Study Details:
Key Inclusion Criteria:
- Diagnosed with Friedreich’s ataxia
- Age 13 and older
- Able to walk with or without a walking aid
- Able to sit safely on a recumbent stationary bicycle
- Reside in the United States
Key Exclusion Criteria:
- Congestive heart failure or prior heart attack
- Joint pain or difficulty in performing exercise
The study is recruiting individuals who are taking omaveloxolone as prescribed by their doctor as well as individuals not taking omaveloxolone. Omaveloxolone will not be provided through the study. Travel compensation will be provided.
Additional inclusion and exclusion criteria may apply and will be evaluated by a study doctor.