Spinocerebellar AtaxiasNCT04837027
Effect of Training on Brain Volume in Ataxia
A study testing Aerobic training and Balance training in people with Spinocerebellar Ataxias, run by Columbia University at 1 site in United States.
Trial summary
The primary 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinocerebellar Ataxias
- What is being tested?
- Aerobic training and Balance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 16 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with spinocerebellar ataxia
- Cerebellar atrophy on MRI
- Prevalence of ataxia on clinical exam
- Ability to safely ride a stationary exercise bike
Who cannot join
- Other neurologic conditions • Heart disease
- Cognitive impairment
- Medical instability
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Balance Versus Aerobic Training in Degenerative Cerebellar Diseases
The primary 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.
Read the 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 impacting the cerebellum
- Conditions
- Spinocerebellar Ataxias
- Being tested
- Aerobic training, Balance training
- Keywords
- Ataxia, Cerebellum, Cerebellar degeneration
- Medical subject headings
- Spinocerebellar Ataxias, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingBehavioural
Aerobic training on stationary bike 5x a week for 30 minutes a day
Balance trainingBehavioural
Training 5x a week for 30 minutes. Standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Aerobic training |
| Balance 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 Receives: Behavioral: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebellar volume
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
- Page 3 of 5 [DRAFT] - multi-atlas skull-striping software package). We will process the longitudinal T1-weighted images
Measured: 6 months
Secondary outcomes (4)
Cognition
The NIH toolbox will be used before and after training to determine impact of training on cognition
Measured: 6 months
Ataxia severity
The Scale for the Assessment and Rating of Ataxia (SARA) will be done to before and after training. This scale ranges from 0 to 40 with higher scores indicating more ataxia
Measured: 6 months
Gait speed
Participants will walk 8 meters as fast as possible
Measured: 6 months
Balance
The dynamic gait index will be performed to test balance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Sep 2021
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinocerebellar AtaxiasStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Barbuto, MD PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837027
- Sponsor's protocol ID
- AAAT1306
- Status last verified
- Oct 2022
- First submitted
- 6 Apr 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Versus Aerobic Training in Degenerative Cerebellar Diseases
- ClinicalTrials.gov ID
- NCT04837027
- Acronym / sponsor ID
- AAAT1306
- Conditions
- Spinocerebellar Ataxias
- Keywords
- Ataxia, Cerebellum, Cerebellar degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary 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.
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 impacting the cerebellum
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Aerobic training | Experimental | Behavioral: Aerobic trainingParticipants 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. |
| Balance training | Active comparator | Behavioral: Balance trainingBalance 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with spinocerebellar ataxia
Key exclusion criteria (3 listed)
- Other neurologic conditions • Heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic trainingAerobic training on stationary bike 5x a week for 30 minutes a day | Behavioural | Aerobic training |
| Balance trainingTraining 5x a week for 30 minutes. Standard of care | Behavioural | Balance training |
Primary outcome
Cerebellar volume
Time frame: 6 months
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 - Page 3 of 5 [DRAFT] - multi-atlas skull-striping software package). We will process the longitudinal T1-weighted images
4 secondary outcomes
Cognition
Time frame: 6 months
Ataxia severity
Time frame: 6 months
Gait speed
Time frame: 6 months
Balance
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Barbuto, MD PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training and Balance training in people with Spinocerebellar Ataxias, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebellar volume (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.