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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to safely ride a stationary exercise bike
Diagnosed with spinocerebellar ataxia
Must not have
Heart disease
Cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 3, and 4 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study how aerobic training affects eyeblink conditioning, which is a type of motor learning related to the cerebellum. The researchers will use a smartphone app called iBlink to test
Who is the study for?
This trial is for individuals with Spinocerebellar Ataxias and related conditions who can perform physical exercises. The study aims to understand if exercise can improve certain brain-related learning processes.
What is being tested?
The study tests whether aerobic training, compared to balance training, enhances a type of learning linked to the cerebellum in the brain. Participants will use an app called iBlink at home to measure outcomes.
What are the potential side effects?
While specific side effects are not listed, typical risks may include muscle soreness or strain from physical activities like balance and aerobic exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can safely use a stationary exercise bike.
Select...
I have been diagnosed with spinocerebellar ataxia.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a heart condition.
Select...
I have difficulty with memory or thinking clearly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 3, and 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 3, and 4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Conditioned Response (CR) Amplitude
Secondary study objectives
6-minute Walk Test (6MWT)
Balance Measures
Maximal Oxygen Consumption (VO2Max)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Aerobic TrainingExperimental Treatment1 Intervention
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. Participants will record duration of exercise, perceived exertion, average heart rate, maximum heart rate, and distance.
Group II: Balance TrainingActive Control1 Intervention
A physical therapist will tailor a home balance training program for each participant based on pre- training capabilities. Participants 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Training
2024
N/A
~880
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,663,160 Total Patients Enrolled
4 Trials studying Spinocerebellar Ataxias
292 Patients Enrolled for Spinocerebellar Ataxias
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