Clinical trial NCT05157802: Promoting Physical Activity Engagement for People With Early-stage Cerebellar Ataxia
Official title: Promoting Physical Activity Engagement for People With Early-stage Cerebellar Ataxia (EngageAtaxia)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Cerebellar Ataxia
Keywords: physical activity
physical therapy
balance training
physical activity coaching
neurodegenerative disease
rehabilitation
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Scale for Assessment and Rating for Ataxia
timeFrame: Baseline, Post-Intervention (3 months)
measure: Change in Cerebellar Cognitive Affective Syndrome Scale
timeFrame: Baseline, Post-Intervention (3 months)
measure: Change in Brunel Lifestyle Physical Activity Questionnaire
timeFrame: Baseline, Post-Intervention (3 months)
Secondary outcomes:
measure: Exercise Identity Scale Exercise Identity Scale
timeFrame: Baseline, Post-Intervention (3 months)
measure: The Self- Efficacy for Exercise Scale
timeFrame: Baseline, Post-Intervention (3 months)
measure: Activities Specific Balance Scale (ABC)
timeFrame: Baseline, Post-Intervention (3 months)
measure: Digital Biomarker of Static Posturography
timeFrame: Baseline, Post-Intervention (3 months)
measure: Digital Biomarker of Dynamic Posturography
timeFrame: Baseline, Post-Intervention (3 months)
measure: Acceptability Questionnaire
timeFrame: Post-intervention (3 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
Study officials:
References: