NCT05826171

Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia

Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia: a Randomized Controlled Trial (PRIME-Ataxia RCT)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Teachers College, Columbia University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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).

Conditions

• Spinocerebellar Ataxia Type 1
• Spinocerebellar Ataxia Type 2
• Spinocerebellar Ataxia Type 3
• Spinocerebellar Ataxia Type 6
• Spinocerebellar Ataxia Type 7

Interventions

Type	Name	Description
BEHAVIORAL	High-Intensity Aerobic Exercise Prior to Balance Training	20-30 minutes of high intensity aerobic exercise followed by 20-30 minutes of individualized balance training over telehealth twice weekly, for 8 weeks (16 sessions total). For the aerobic component, participants will be instructed in a 20-30-minute exercise program, using available equipment already located in the participant's home (eg. stationary cycle, elliptical trainer, etc). Exercise intensity is moderate-to-high (between 50-85% Heart Rate Reserve. Participants will be placed on a ramped protocol which increases in intensity slowly over the course of the intervention period. For the balance training component, exercises will consist of steady state, proative, and reactive balance activities that involve sensory integration of vision, proprioception, and vestibular senses. Exercises will be individualized based on baseline assessment outcomes and severity of ataxia as rated by the SARAHome.
BEHAVIORAL	Low-Intensity Exercise Prior to Balance Training	20-30 minutes of light intensity "warm-up" type exercises, followed by 20-30 minutes of individualized balance training over telehealth twice weekly, for 8 week (16 sessions total). For the "warm-up" exercise component, exercises will consist of stretching and core training. For the balance training component, exercises will consist of steady state, proactive, and reactive balance activities that involve sensory integration of vision, proprioception, and vestibular senses throughout. Exercises will be individualized based on baseline assessment outcomes and severity of ataxia as rated by the SARAHome. Both groups are matched for time and frequency of intervention components.

Timeline

• Start date: 2023-02-06
• Primary completion: 2024-12-01
• Completion: 2025-05-31
• First posted: 2023-04-24
• Last updated: 2024-05-03

Locations

1 site across 1 country: United States