Clinical trial NCT03701776: Ataxia and Exercise Disease Using MRI and Gait Analysis
Official title: Effects of Aerobic Exercise Verse Balance Training on Degenerative Cerebellar Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ataxia
Spino Cerebellar Degeneration
Spinocerebellar Ataxias
Keywords: Ataxia, exercise, spinocerebellar disease, neuroimaging
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind randomized control trial
Primary purpose: TREATMENT

Brief summary: The first aim is to show balance training improves DCD individual's ability to compensate for their activity limitations, but does not impact disease progression.

The second aim is to demonstrate aerobic exercise improves balance and gait in DCD persons by affecting brain processes and slowing cerebellar atrophy.

Detailed description: Individuals with degenerative cerebellar disease (DCD) exhibit gradual loss of coordination resulting in impaired balance, gait deviations, and severe, progressive disability. With no available disease-modifying medications, balance training is the primary treatment option to improve motor skills and functional performance. There is no evidence, however, that balance training impacts DCD at the tissue level.

Aerobic training, on the other hand, may modify DCD progression as evident from animal data. Compared to sedentary controls, aerobically trained DCD rats have enhanced lifespan, motor function, and cerebellar Purkinje cell survival. Numerous animal studies also document that aerobic training has a direct, favorable effect on the brain that includes production of neurotrophic hormones, enhancement of neuroplasticity mechanisms, and protection from neurotoxins.

The effects of aerobic training in humans with DCD are relatively unknown, despite these encouraging animal data. A single study to date has evaluated the benefits of aerobic exercise on DCD in humans, and this was a secondary outcome of the study. Although participants performed limited aerobic training during the study, modest functional benefits were still detected.

The main objective of this project will be to compare the benefits of aerobic versus balance training in DCD. We hypothesize that both aerobic and balance training will improve function in DCD subjects, but that the mechanisms in which these improvements occur differ. 1) Balance training improves DCD individual's ability to compensate for their activity limitations, but does not impact disease progression. 2) Aerobic exercise improves balance and gait in DCD persons by affecting brain processes and slowing cerebellar atrophy.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with spinocerebellar ataxia
* Cerebellar atrophy on MRI
* Prevalence of ataxia on clinical exam
* Ability to safely ride a stationary exercise bike

Exclusion Criteria:

* Other neurologic conditions
* Heart disease
* Cognitive impairment
* Medical instability

Primary outcomes:
measure: Change in SARA scores
timeFrame: 6 months
Secondary outcomes:
measure: Change in gait parameters
timeFrame: 6 months
measure: Change in cerebellar volume
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University/New York Presbyterian
state: New York
Study officials:
affiliation: Columbia University
name: Scott Barbuto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barbuto S, Kuo SH, Winterbottom L, Lee S, Stern Y, O'Dell M, Stein J. Home Aerobic Training for Cerebellar Degenerative Diseases: a Randomized Controlled Trial. Cerebellum. 2023 Apr;22(2):272-281. doi: 10.1007/s12311-022-01394-4. Epub 2022 Mar 18.