Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia

NCT ID: NCT05826171

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-06
• Study Completion Date: 2025-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

High-Intensity Aerobic Exercise Prior to Balance Training

Group Type: EXPERIMENTAL

High-Intensity Aerobic Exercise Prior to Balance Training

Intervention Type: BEHAVIORAL

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.

Group 2

Low-Intensity Exercise Prior to Balance Training

Group Type: ACTIVE_COMPARATOR

Low-Intensity Exercise Prior to Balance Training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teachers College, Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lori Quinn, PT, EdD

Role: PRINCIPAL_INVESTIGATOR

Teachers College, Columbia University

Chelsea E Macpherson, DPT

Role: PRINCIPAL_INVESTIGATOR

Teachers College, Columbia University

Locations

Teachers College, Columbia University

New York, New York, United States

Countries

United States

Other Identifiers

23-088

Identifier Type: -

Identifier Source: org_study_id