Exercise Intensity and Balance Training for Spinocerebellar Ataxia

(PRIME-Ataxia Trial)

Overseen By Jehan Alomar, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Teachers College, Columbia University

Disqualifiers: Severe motor symptoms, Sensory loss, Visual complications, Musculoskeletal injury, Cerebellum disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two different online exercise routines for people with spinocerebellar ataxias (SCAs). One routine involves intense cardio workouts before balance exercises, while the other involves light exercises like stretching before balance exercises. The goal is to see which routine better improves balance and motor skills in people with SCAs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on exercise and balance training, so it's best to discuss your medications with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment High-Intensity Aerobic Exercise Prior to Balance Training and Low-Intensity Exercise Prior to Balance Training for Spinocerebellar Ataxia?

Research shows that home aerobic training can significantly improve symptoms of ataxia (a condition affecting coordination and balance) compared to balance training alone. High-intensity motor training, including aerobic exercise, may also enhance balance and coordination in patients with spinocerebellar ataxia, although the benefits may diminish if the training is stopped. ^{1 2 3 4 5}

Is exercise intensity and balance training safe for people with spinocerebellar ataxia?

Research shows that both aerobic and balance training are generally safe for people with cerebellar ataxia, with no serious adverse events reported. Participants in a study had good adherence to the training, and minor issues like falls or back pain did not interrupt the training. ^{1 3 6 7 8}

How does the treatment of high-intensity aerobic exercise prior to balance training differ from other treatments for spinocerebellar ataxia?

This treatment is unique because it combines high-intensity aerobic exercise with balance training, which may enhance the remaining brain circuits or create new compensatory networks, potentially leading to better improvements in balance and coordination compared to traditional rehabilitation methods. ^{1 2 5 9 10}

Research Team

Lori Quinn, PT, EdD

Principal Investigator

Teachers College, Columbia University

Chelsea E Macpherson, DPT

Principal Investigator

Teachers College, Columbia University

Eligibility Criteria

This trial is for people aged 18-85 with a confirmed genetic diagnosis of Spinocerebellar Ataxia types SCA1, 2, 3, 6, or 7. Participants should have mild to moderate disease severity and be able to walk with or without help. They need a care partner available during sessions and must not have been doing intense exercise recently.

Inclusion Criteria

My ataxia is mild to moderate, with a SARA score between 8-25.

I can walk, with or without help from a device.

My condition is genetically confirmed as SCA1, 2, 3, 6, or 7.

Exclusion Criteria

My heart or lung condition doesn't limit my ability to exercise.

You have confirmed loss of feeling in your hands or feet.

I have severe vision problems due to my ataxia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including digital posturography and motor task assessments

1 week

2 visits (remote)

Treatment

Participants receive an 8-week telehealth intervention of either high or low intensity exercise followed by balance training

8 weeks

Weekly remote sessions

Mid-Intervention Assessment

Participants undergo a mid-intervention assessment to evaluate progress

1 week

1 visit (remote)

Post-Intervention Assessment

Participants undergo post-intervention assessments including digital posturography and motor task assessments

1 week

1 visit (remote), 1 visit (in-person for a subset)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• High-Intensity Aerobic Exercise Prior to Balance Training
• Low-Intensity Exercise Prior to Balance Training

Trial Overview The PRIME-Ataxia study tests if high-intensity aerobic exercise before balance training is more effective than low-intensity exercise for the same purpose in individuals with SCAs. This telehealth program runs for eight weeks and includes an assessment of motor skill learning.

Participant Groups

Group I: Group 1 Experimental Treatment 1 Intervention

High-Intensity Aerobic Exercise Prior to Balance Training

Group II: Group 2 Active Control 1 Intervention

Low-Intensity Exercise Prior to Balance Training

Who Is Running the Clinical Trial?

Teachers College, Columbia University

Lead Sponsor

Trials

27

Recruited

6,100+

Findings from Research

High intensity training (HIT) is safe and well-tolerated by individuals with multiple sclerosis (MS), showing significant improvements in walking speed and endurance based on a review of 13 studies involving 375 participants.

While HIT demonstrates benefits for certain functional outcomes like walking, the variability in training protocols and exercise types means more research is needed to draw definitive conclusions about its overall effectiveness on balance and mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High intensity exercise training on functional outcomes in persons with multiple sclerosis: A systematic review. Bae, M., Kasser, SL.[2023]

Rehabilitation interventions for spinocerebellar ataxia showed significant improvements in balance and gait, with statistical significance for posture (P<.008) and gait (P<.02).

The interventions also led to notable reductions in speech disorders (P=.02), depressive symptoms (P<.0001), and accidental falls (P<.005), indicating a broader impact on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of physical rehabilitation in patients with hereditary spinocerebellar ataxia. A systematic review]. Marchal-Muñoz, A., García-Aranda, M., Marchal-Muñoz, M., et al.[2021]

A review of 20 studies on non-aerobic exercise interventions for improving balance and gait in individuals with mild-to-moderate traumatic brain injury (TBI) found limited evidence of effectiveness, highlighting the need for better quality research.

The studies reviewed often had small sample sizes and varied methodologies, indicating that future research should focus on standardizing interventions and outcome measures to provide clearer insights into their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of physical therapy for improving gait and balance in individuals with traumatic brain injury: a systematic review. Bland, DC., Zampieri, C., Damiano, DL.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Home Aerobic Training for Cerebellar Degenerative Diseases: a Randomized Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Partial Body Weight-Supported Treadmill Training in Spinocerebellar Ataxia. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

High intensity exercise training on functional outcomes in persons with multiple sclerosis: A systematic review. [2023]

4. Spain pubmed.ncbi.nlm.nih.gov

[Effect of physical rehabilitation in patients with hereditary spinocerebellar ataxia. A systematic review]. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Update on intensive motor training in spinocerebellar ataxia: time to move a step forward? [2021]

6. Japan pubmed.ncbi.nlm.nih.gov

Decreasing fall risk in spinocerebellar ataxia. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

The acute, systemic effects of aerobic exercise in recently concussed adolescent student-athletes: preliminary findings. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effectiveness of physical therapy for improving gait and balance in individuals with traumatic brain injury: a systematic review. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Phase I randomized single-blinded controlled study investigating the potential benefit of aerobic exercise in degenerative cerebellar disease. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of Physical Rehabilitation in Patients with Spinocerebellar Ataxia Type 7. [2020]