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Aerobic Exercise, Balance Training, and Ataxia

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ClinicalTrials.gov Identifier: NCT03745248
Recruitment Status : Completed
First Posted : November 19, 2018
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Joel Stein, MD, Columbia University

Tracking Information
First Submitted Date  ICMJE November 14, 2018
First Posted Date  ICMJE November 19, 2018
Last Update Posted Date December 11, 2019
Actual Study Start Date  ICMJE November 14, 2018
Actual Primary Completion Date June 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
Change in SARA score [ Time Frame: 1 month ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
  • Change in gait speed [ Time Frame: 1 month ]
    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 [ Time Frame: 1 month ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aerobic Exercise, Balance Training, and Ataxia
Official Title  ICMJE Effects of Aerobic Exercise on Degenerative Cerebellar Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Single blind randomized control trial
Masking: Single (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
Primary Purpose: Treatment
Condition  ICMJE
  • Ataxia
  • Spino Cerebellar Degeneration
  • Spinocerebellar Ataxias
Intervention  ICMJE
  • Behavioral: Aerobic training
    Aerobic training on stationary bicycle for 30 minutes a day, 5 days a week for 1 month
  • Behavioral: Balance Training
    Standard of care
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Aerobic training
  • 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.
    Intervention: Behavioral: Balance Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 14, 2019
Actual Primary Completion Date June 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03745248
Other Study ID Numbers  ICMJE AAAR5381
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Joel Stein, MD, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joel Stein, MD Columbia University
PRS Account Columbia University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP