Promoting Physical Activity Engagement for People With Early-stage Cerebellar Ataxia

NCT05157802 | Active Not Recruiting Phase 1

• 1 other identifier: 21-042
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Engage-Ataxia will implement a physical activity coaching program for people with cerebellar ataxia at Teachers College, Columbia University. This program expands upon the current Engage program for people with Parkinson's disease (Engage-PD), an exercise coaching program for people with early stage Parkinson's disease to target individuals with early stage cerebellar ataxia. Engage-Ataxia will utilize a physical or occupational therapist to provide up to five one-on-one coaching sessions for individuals newly diagnosed with cerebellar ataxia. Therapists will work with participants to provide individualized structured support to facilitate and optimize exercise uptake as one part of comprehensive disease management. Participants will undertake two assessments three months apart, and will receive coaching interventions via Zoom healthcare platform. The primary objective of this program is to increase physical activity and exercise engagement in individuals with early stage cerebellar ataxia. This feasibility study will provide preliminary data and insight into the benefits of a remote coaching intervention for people with cerebellar ataxia.

Conditions

Cerebellar Ataxia

Keywords

physical activity; physical therapy; balance training; physical activity coaching; neurodegenerative disease; rehabilitation

Outcome Measures

Primary Outcomes (3)

• Change in Scale for Assessment and Rating for Ataxia

  Clinical rating scale for severity of ataxia symptoms. This is an 8-item clinical performance based scale, which individuals are graded according to total ataxia severity. Total scores can range from 0 (no ataxia) to 40 (most severe ataxia). Scores are based on performance of the following tasks: 1) Gait, 2) Stance, 3), Sitting, 4) Speech Disturbance, 5) Finger Chase, 6) Nose-Finger Test, 7) Fast alternating hand movements, 8) Heel-shin slide. For the purpose of this study, we will be performing a modified version of the SARA, and be using the first four items of the SARA Scale (Gait, Stance, Walking, Speech) to be administered via telehealth.

  Baseline, Post-Intervention (3 months)

• Change in Cerebellar Cognitive Affective Syndrome Scale

  The Cerebellar Cognitive Affective Syndrome Scale (CCAS) was developed as a bedside quick screen for Cerebellar Cognitive Affective Symptom (also referred to as Schmalmann's Syndrome). The CCAS is a 10-item scale of cognitive and neuropsychiatric tests detailing executive function, working and verbal memory, language, visuospatial function, abstract reasoning, behavior and affect. Two scores are reported; a raw score ranging from 0 (severe cognitive impairment) to 120 points (no cognitive impairment), as well as a Pass/Fail marker for each of the 10 items on the scale. 1 fail is considered as possible cerebellar cognitive affective symptom, 2 fails are considered probable, and 3 fails are considered clinically definite.

  Baseline, Post-Intervention (3 months)

• Change in Brunel Lifestyle Physical Activity Questionnaire

  Evaluates both pre-planned and unplanned physical activity. Both pre-planned and unplanned physical activity subsections are separately scored through summation and average. Higher averages (closer to 5) indicate greater physical activity, whereas lower averages (closer to 0) indicate little to no physical activity in either category.

  Baseline, Post-Intervention (3 months)

Secondary Outcomes (6)

• Exercise Identity Scale Exercise Identity Scale

  Baseline, Post-Intervention (3 months)

• The Self- Efficacy for Exercise Scale

  Baseline, Post-Intervention (3 months)

• Activities Specific Balance Scale (ABC)

  Baseline, Post-Intervention (3 months)

• Digital Biomarker of Static Posturography

  Baseline, Post-Intervention (3 months)

• Digital Biomarker of Dynamic Posturography

  Baseline, Post-Intervention (3 months)

Study Arms (1)

Physical Activity Coaching

EXPERIMENTAL

Participants will receive up to 5 individualized coaching sessions delivered via telehealth to facilitate and optimize exercise uptake. The therapist will facilitate discussion on specific and measurable goals, and will provide options for tracking their progress, such as written or web-based exercise logs or an activity monitor. The recommended exercises will be individualized to each participant but will primarily focus on increasing general physical activity (e.g. steps per day) as well as engagement in moderate intensity aerobic exercise a minimum of three times per week. Balance and strengthening exercises will also be recommended as appropriate.

Behavioral: Physical activity coaching

Interventions

Physical activity coaching BEHAVIORAL

Physical activity coaching over 5 sessions

Physical Activity Coaching

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Neurologist confirmed diagnosis of cerebellar ataxia
• Scale for Ataxia Rating and Assessment (SARA) score between 8-25 (total score of 40), which will capture mild to moderate stage of the disease
• Ambulatory for indoor and outdoor mobility without assistance or assistive device
• Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) or medical clearance from primary doctor
• Medical clearance to exercise

You may not qualify if:

• Musculoskeletal injury that would prevent participation in an exercise program
• Other neurological disease or disorder such as stroke
• Cardiac/pulmonary conditions that would affect participants ability to participate exercise program
• Metabolic conditions that would affect participants during an exercise program
• Currently do moderate-vigorous exercise 5 days a week or more

Sponsors & Collaborators

• Teachers College, Columbia University: lead

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Cerebellar Ataxia; Motor Activity; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 15, 2021
• Study Start: March 26, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)