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Aerobic Exercise, Balance Training, and Ataxia

Primary Purpose

Ataxia, Spino Cerebellar Degeneration, Spinocerebellar Ataxias

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic training
Balance Training
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ataxia focused on measuring Degenerative cerebellar disease, Ataxia, Aerobic Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University/New York Presbyterian

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic Training

Balance Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
November 14, 2018
Last Updated
December 9, 2019
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03745248
Brief Title
Aerobic Exercise, Balance Training, and Ataxia
Official Title
Effects of Aerobic Exercise on Degenerative Cerebellar Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 14, 2018 (Actual)
Primary Completion Date
June 9, 2019 (Actual)
Study Completion Date
October 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ataxia, Spino Cerebellar Degeneration, Spinocerebellar Ataxias
Keywords
Degenerative cerebellar disease, Ataxia, Aerobic Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind randomized control trial
Masking
Outcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Balance Training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic training
Intervention Description
Aerobic training on stationary bicycle for 30 minutes a day, 5 days a week for 1 month
Intervention Type
Behavioral
Intervention Name(s)
Balance Training
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
Change in SARA score
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Change in gait speed
Description
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.
Time Frame
1 month
Title
Change in static balance
Description
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).
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Stein, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University/New York Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32383352
Citation
Barbuto S, Martelli D, Isirame O, Lee N, Bishop L, Kuo SH, Agrawal S, Lee S, O'Dell M, Stein J. Phase I Single-Blinded Randomized Controlled Trial Comparing Balance and Aerobic Training in Degenerative Cerebellar Disease. PM R. 2021 Apr;13(4):364-371. doi: 10.1002/pmrj.12401. Epub 2020 May 29.
Results Reference
derived

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Aerobic Exercise, Balance Training, and Ataxia

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