- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03701776
Ataxia and Exercise Disease Using MRI and Gait Analysis
Effects of Aerobic Exercise Verse Balance Training on Degenerative Cerebellar Disease
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10035
- Columbia University/New York Presbyterian
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aerobic Training
Participants will be given a stationary exercise bike for home use.
They will be instructed to use the exercise bike five times a week for thirty-minute sessions.
The exercise intensity prescription will be based on the subject's VO2max determined on pre-test day.
The exercise program will start at 60% of intensity per session, and then will be increased by steps of 5% intensity every 2 sessions until participants reach 30 minutes of training at 80% intensity.
Participants will be contacted weekly by e-mail or phone to answer any questions about the exercise protocol and will be instructed to log each training session.
Subjects will record duration of exercise, perceived exertion, average heart rate, maximum heart rate, and distance.
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Aerobic training on stationary bicycle for 30 minutes a day, 5 days a week for 6 months
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Active Comparator: Balance Training
A physical therapist will tailor a home balance training program for each participant based on pre-training capabilities.
Subjects will be asked to perform exercises five times a week for thirty-minute sessions.
Both dynamic and static exercises will be performed in sitting and standing positions.
Exercises will start with stabilizing in a challenging static position and progress to dynamic arm and leg movements in the same or modified position.
Participants will be contacted weekly by e-mail or phone to answer any questions about the exercise protocol and will be required to log their exercise effort in terms of frequency and level of balance challenge.
Individuals will be instructed to perform more difficult exercises if balance challenge scores are low.
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Standard of care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in SARA scores
Time Frame: 6 months
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Ataxia severity will be measured using the Scale for the Assessment and Rating of Ataxia (SARA).17
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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in gait parameters
Time Frame: 6 months
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For the walking assessment, participants will walk as fast as possible on a 10-meter runway six times, and we will average the times of trials 3-6.
We will also collect marker position data from infrared emitting diodes placed bilaterally at the first and fifth metatarsal heads, heels, medial and lateral malleoli, medial and lateral condyles of the knee, head of the fibula, and anterior and posterior superior iliac crests pelvic crests using a three-dimensional Vicon motion capture system (Vicon, Denver, CO).
Custom Nexus and Bodybuilder software will be used to calculate joint position and determine the following walking parameters: stride length, stride length variability, percent time in double limb support, and degree of pelvic rotation and tilt.
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6 months
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Change in cerebellar volume
Time Frame: 6 months
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Cranial MRI will be performed in all participants using a 3-T scanner.
Using each individual's T1-weighted image, structural imaging measures of cerebellar brain volume will be derived using the FreeSurfer software package (http://surfer.nmr.mgh.harvard.edu/).
FreeSurfer will automatically assign a neuroanatomic label to each voxel.
From this labeling, a set of volumetric regions of interest is defined.
The calculated volume within the cerebellar region is adjusted for variations in individual's intracranial brain volume (ICV) which is measured using BrainWash (an automatic multi-atlas skull-striping software package).
We will process the longitudinal T1-weighted images using FreeSurfer longitudinal pipeline, recently implemented to detect small or subtle changes over time.
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Scott Barbuto, MD, PhD, Columbia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Dyskinesias
- Spinal Cord Diseases
- Heredodegenerative Disorders, Nervous System
- Cerebellar Diseases
- Ataxia
- Cerebellar Ataxia
- Spinocerebellar Ataxias
- Spinocerebellar Degenerations
Other Study ID Numbers
- AAAS0414
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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