Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia (PRIME-Ataxia)

Teachers College, Columbia University

Status: Active, not recruiting

Conditions: Spinocerebellar Ataxia Type 7; Spinocerebellar Ataxia Type 6; Spinocerebellar Ataxia Type 2; Spinocerebellar Ataxia Type 1; Spinocerebellar Ataxia Type 3

Treatments: Behavioral: High-Intensity Aerobic Exercise Prior to Balance Training; Behavioral: Low-Intensity Exercise Prior to Balance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05826171

23-088

Details and patient eligibility

About

PRIME-Ataxia is a randomized controlled trial that aims to determine the feasibility and efficacy of an 8-week telehealth intervention of high intensity aerobic exercise prior to balance training compared to an 8-week telehealth intervention of low intensity exercise prior to balance training in people with spinocerebellar ataxias (SCAs). The investigators additionally aim to explore changes in motor skill learning on a novel motor skill task in a sub-group of participants pre and post intervention.

Full description

The PRIME-Ataxia randomized controlled trial involves 2 groups of participants (n=20). One group (high intensity exercise + balance) will receive high intensity aerobic exercise followed by balance training, and another group (low intensity exercise + balance) will receive low intensity exercise (stretching, warm up exercises) followed by balance training. Both groups will undergo four remote assessments (2 baseline assessments, a mid-intervention assessment, and a post-intervention assessment). A subset of individuals (n=12) from both groups will undergo an in-person assessment on a novel motor task, along with digital posturography assessment of standard functional assessments of mobility and balance at baseline 1 (week 0), and post-intervention (week 16).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Between the ages of 18 to 85 years
2. Genetically confirmed diagnosis of SCA1, 2, 3, 6, and 7
3. Scale for Ataxia Rating and Assessment (SARA) score between 8-25/40, capturing mild-moderate disease
4. Able to walk with/without assistive device
5. Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) to confirm no medical contraindications to exercise
6. Care partner availability during assessments and/or intervention pending balance scores

Exclusion criteria

1. Severe non-ataxic motor symptoms such as dystonia, tremor, or Parkinsonism, measured by Inventory of Non-Ataxia Signs (INAS)
2. Peripheral sensory loss (as confirmed with monofilament or clinical proprioceptive testing)
3. Severe visual complications associated with ataxia (i.e., Spontaneous nystagmus, retinal or optic nerve involvement, especially in SCA7) defined as as have a score on the Snellen Visual Acuity test = 20/200 - 20/400, OR a visual field of 20 degrees of less.
4. Musculoskeletal injury that would prevent participation in an exercise program
5. Other concurrent disease of the cerebellum (e.g. stroke, multiple sclerosis)
6. Cardiac/pulmonary conditions that would affect participants ability to participate exercise program
7. Currently engaged in >3 week moderate-high intensity aerobic exercise and/or balance training

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Group 1

Experimental group

Description:

High-Intensity Aerobic Exercise Prior to Balance Training

Treatment:

Behavioral: High-Intensity Aerobic Exercise Prior to Balance Training

Group 2

Active Comparator group

Description:

Low-Intensity Exercise Prior to Balance Training

Treatment:

Behavioral: Low-Intensity Exercise Prior to Balance Training