Cardiac Output and Fatigue in Friedreich's Ataxia

Part of paid clinical trials in New York, New York.

Sponsor
Scott Barbuto
Study ID
NCT07444333
Status
Recruiting
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Conditions

  • Friedreich's Ataxia

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 2, 2026
Start date
Jul 15, 2026
Status verified
Sep 2026
Primary completion
Feb 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Home Aerobic Training on Omaveloxolone
    Participants who are currently taking Skyclarys (omaveloxolone) will be given a recumbent exercise bike (Marcy ME-709 Adjustable Recumbent Exercise Bike, Pomona, CA) for home use. They will be instructed to exercise five times a week. The regimen will include 5-minute warm up, 30 minutes of exercise at target heart rate, and 5 minutes of cool down.
  • Active Comparator: Home Aerobic Training off Omaveloxolone
    Participants who are not taking Skyclarys (omaveloxolone) will be given a recumbent exercise bike (Marcy ME-709 Adjustable Recumbent Exercise Bike, Pomona, CA) for home use. They will be instructed to exercise five times a week. The regimen will include 5-minute warm up, 30 minutes of exercise at target heart rate, and 5 minutes of cool down.

Primary Outcome Measure

Adverse events (Primary outcome for Aim 1) [ Time Frame: 0, 3, 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Scott M Barbuto, MD PhD
[email protected]
212-305-3535
Scott M Barbuto, MD PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center· New York, NY

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