Ataxia and Exercise Disease Using MRI and Gait Analysis

NCT03701776 | Completed

• 1 other identifier: AAAS0414
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Ataxia; Spino Cerebellar Degeneration; Spinocerebellar Ataxias

Keywords

Ataxia, exercise, spinocerebellar disease, neuroimaging

Outcome Measures

Primary Outcomes (1)

• Change in SARA scores

  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.

  6 months

Secondary Outcomes (2)

• Change in gait parameters

  6 months

• Change in cerebellar volume

  6 months

Study Arms (2)

Aerobic Training

EXPERIMENTAL

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.

Behavioral: Aerobic Training

Balance Training

ACTIVE COMPARATOR

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.

Behavioral: Balance Training

Interventions

Aerobic Training BEHAVIORAL

Aerobic training on stationary bicycle for 30 minutes a day, 5 days a week for 6 months

Aerobic Training

Balance Training BEHAVIORAL

Standard of care

Balance Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University/New York Presbyterian

New York, New York, 10035, United States

Location

Related Publications (1)

• 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.

  PMID: 35303255 DERIVED

MeSH Terms

Conditions

Ataxia; Spinocerebellar Degenerations; Spinocerebellar Ataxias; Motor Activity

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cerebellar Ataxia; Behavior

Study Officials

• Scott Barbuto, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will know that the participant has received balance or aerobic training, but will not be aware of which group the participant belonged.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Medicine and Rehabilitation

Model Details: Single blind randomized control trial

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 10, 2018
• Study Start: January 13, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)