Aerobic Exercise, Balance Training, and Ataxia

Ataxia Clinical Trial

Official title:

Effects of Aerobic Exercise on Degenerative Cerebellar Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03745248
• Other study ID #: AAAR5381
• Status: Completed
• Phase: N/A
• Start date: November 14, 2018
• Est. completion date: October 14, 2019

Study information

• Verified date: December 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The first aim is to show aerobic training improves degenerative cerebellar patients functionally

The second aim is to compare the effects of balance and aerobic training on degenerative cerebellar disease.

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.

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. The investigators hypothesize that both aerobic and balance training will improve function in DCD subjects, but that the mechanisms in which these improvements occur differ.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 14, 2019
• Est. primary completion date: June 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia
• Cerebellar Diseases
• Spino Cerebellar Degeneration
• Spinocerebellar Ataxias
• Spinocerebellar Degenerations

Intervention

Behavioral:
• Aerobic training
Aerobic training on stationary bicycle for 30 minutes a day, 5 days a week for 1 month
• Balance Training
Standard of care

Locations

Country	Name	City	State
United States	Columbia University/New York Presbyterian	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in SARA score	Ataxia severity will be measured using the Scale for the Assessment and Rating of Ataxia (SARA).SARA evaluates the degree of ataxia by measuring gait, stance, sitting balance, speech, finger-chase test, nose-finger test, fast alternating movements, and heel-shin test.	1 month
Secondary	Change in gait speed	For the walking assessment, participants will walk as fast as possible on a 10-meter runway six times, and the investigators will average the times of trials 3-6 to determine gait speed expressed in meters/second.	1 month
Secondary	Change in static balance	Static standing balance will be assessed by measuring postural sway during two, one-minute trials. Participants will stand with arms crossed over their chest and feet shoulder-width apart under two conditions: eyes open and eyes closed. Data will be collected using Bertec's dual split-belt treadmill (Bertec, Columbus, OH) embedded with force plates. Balance deficits will be calculated as the magnitude of postural sway (sway amplitude) using custom Nexus and Bodybuilder software (Vicon, Denver, CO).	1 month