Clinical trial NCT04922190: Promoting Physical Activity Engagement for People With Early-mid Stage Parkinson's Disease (Engage-PD)
Official title: Promoting Physical Activity Engagement for People With Early-mid Stage Parkinson's Disease (Engage-PD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Parkinson Disease
Keywords: physical activity
exercise
rehabilitation
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2021-06-10
Enrollment: 100
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-PD is a single cohort evaluation of implementation of a telehealth-delivered physical activity coaching program for people with early-mid stage Parkinson's disease. The program utilizes a physical or occupational therapist to provide one-on-one coaching for individuals with early-mid stage Parkinson's disease to provide individualized structured support to facilitate and optimize exercise uptake as part of an effective self-management program. The structure of the coaching program is based on previous research in neurodegenerative disease including Parkinson's disease and Huntington's disease.

Detailed description: Individuals will be recruited through the Columbia University Medical Center Parkinson's Disease Center of Excellence. Individuals who choose to participate will first be given a brief evaluation, including history and contraindications for exercise, assessment of gait and balance, physical activity questionnaire (Brunel Lifestyle Inventory and International Physical Activity Questionnaire), pain questionnaire (Brief Pain Inventory), NeuroQOL quality of life assessment, and a self-efficacy measure about exercise engagement (Exercise Self Efficacy Scale). For those individuals who report low back pain, we will further administer the Modified Oswestry Low Back Pain Disability Questionnaire and a customized low back pain questionnaire. The therapist will then conduct the coaching session (see below). If this assessment is not able to be conducted in person, it will be conducted via secure videoconferencing. There will be between 1-4 follow-up phone call/videosessions and a follow-up assessments at 3 months and 6 months where all assessment will be repeated. A short questionnaire will also be administered at 3 and 6 months to assess the acceptability of the intervention.

The coaching program will utilize the Pre-Active PD program (Clinicaltrials.gov NCT03696589) to guide the delivery of the intervention. This will include a checklist of the key elements that are important for the therapist in order to facilitate PA behavior change. In addition, the therapist will utilize motivational interviewing strategies that include four processes (engaging, evoking, planning, and tracking) and five core communication skills (asking open ended questions, affirming, reflective listening, summarizing, and informing and advising). The therapist will introduce the Pre-Active PD workbook and utilize it as a tool and reference for the participant in order to engage and focus them throughout the coaching process, and will educate participants on the types of exercise options and the specific exercise benefits for PD. In the planning process, the therapist will facilitate discussion on development of 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-vigorous intensity aerobic exercise a minimum of three times per week. Balance and strengthening exercises will also be recommended as appropriate. At the follow up sessions (15-30 min), the therapist will review progress with the current exercise plan and progress, record if any falls have occurred and discuss barriers and facilitators for exercise engagement. Participants will also be given a short exercise safety checklist to assure safety when conducting home exercises. Participants will have the option to use a Fitbit device (Charge 4) to monitor their heart rate and physical activity during the course of the intervention period. Participants will use a study-specific login to track their progress and activity. Participants who already own a Fitbit or other activity monitor can continue to use their device during the study.

Eligibility criteria: Inclusion Criteria:

* Neurologist confirmed clinical diagnosis for Parkinson's disease Hoehn \& Yahr stage I-III
* Ambulatory for indoor and outdoor mobility without assistance or assistive device
* Successful completion of Physical Activity Readiness Questionnaire (PAR-Q)26 or medical clearance from GP

Exclusion Criteria:

* Musculoskeletal injury that would prevent participation in an exercise program
* Other neurological disease or disorder such as stroke

Primary outcomes:
measure: Brunel Lifestyle Physical Activity Questionnaire
timeFrame: 3 months
measure: Self-Efficacy for Exercise Scale
timeFrame: 3 months
Secondary outcomes:
measure: International Physical Activity Questionnaire (Short-Form Phone version)
timeFrame: 3 months
measure: NeuroQOL
timeFrame: 3 months
measure: Brief Pain Inventory
timeFrame: 3 months
measure: Timed Up and Go
timeFrame: 3 months
measure: Standing balance assessment
timeFrame: 3 months
measure: Modified Oswestry Low Back Pain Disability Questionnaire
timeFrame: 3 months
measure: Acceptability questionnaire (open-ended questions)
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
Study officials:
References: