Clinical trial NCT05308238: Pre-Active PD: Looking At Physical Activity Behavior Change in Parkinson's Disease
Official title: Pre-Active PD: a Randomized Control Trial (RCT) Pilot Study to Improve Self-management of Physical Activity (PA) Routines in Adults with Early-stage Parkinson's Disease (PD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: behavior change
exercise
physical activity
occupational therapy
Lead sponsor: San Jose State University
Sponsor class: OTHER
Collaborators: name: Teachers College, Columbia University
First posted: 2022-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled feasibility study
Primary purpose: TREATMENT

Brief summary: Pre-Active PD is a randomized controlled feasibility study to evaluate the implementation of a telehealth-delivered physical activity behavior change intervention for people with early-mid stage Parkinson's disease. The program utilizes occupational therapists to provide one-to-one individualized support to facilitate and optimize exercise uptake as part of their disease self-management. The structure of the intervention is based on previous research in neurodegenerative disease including Parkinson's disease and Huntington's disease.

Detailed description: This study will utilize a randomized controlled trial design to assess the feasibility and acceptability of the Pre-Active PD intervention for people with Parkinson's Disease who are in the early disease stage (Hoehn \& Yahr stage I or II). The study will compare an experimental group (occupational therapy for exercise behavior change) to a control group (education only). Both groups will be matched for contact time. Individuals will be recruited through the Columbia University Medical Center Parkinson's Disease Center of Excellence. The study will also be listed on the Fox Trial Finder, a website maintained through the Michael J Fox Foundation. Individuals who choose to participate will be screened for eligibility using the inclusion/exclusion criteria and complete the PAR-Q+ safety screen or have medical clearance from their general practitioner. After randomization, participants will be assessed for cognition and history of occupational therapy (OT) and physical therapy (PT). Measures of acceptability will include retention and completion rates, Fitbit wear-time, and the Perceived Autonomy Support Healthcare Climate Questionnaire (PAS-HCCQ). Implementation will be assessed by the Rating Tool to Assess Fidelity of Intervention Delivery. Physical activity levels will be measured by a wearable activity monitor (Actigraph™ GT9X), worn 7 consecutive days pre and post intervention and 2nd follow-up, as well as a questionnaire. We will also use the Self-Efficacy for Exercise Scale and measure balance and mobility. Descriptive statistics (mean, standard deviation) will be calculated for all demographic information and resultant outcome measures.

Baseline and follow-up outcome measures include the following domains: exercise self-efficacy scale, exercise motivation (Behavioral Regulation In Exercise Questionnaire, physical activity levels (Brunel Lifestyle Physical Activity Questionnaire; ActiGraphTM wearable activity monitor, and Modified PA-R Question), physical performance measures (TUG Single Task and Dual Task Cognitive Version; 30 second sit-to-stand; Modified 2 Minute Step Test), self-perception measures (Modified Canadian Occupational Performance Measure; Patients' Global Impression of Change scale), and the Life Space Assessment.

Participants assigned to the occupational therapy intervention group, will receive 6 telehealth coaching sessions and 8 brief email or text check-ins over the course of 4 months. They will also receive a Fitbit and Engage PD Workbook. The third coaching session will be audio and video-recorded (if consented) and later viewed by an assessor to determine how well the intervention was delivered. The recording will be stored until completion of the study. Declining to be recorded will not affect study participation.

The OT intervention group 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 give the participant a Fitbit physical activity monitor so that they can self-monitor their heart rate and physical activity during the course of the intervention period. 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. Participants will also be given a short exercise safety checklist to assure safety when conducting home exercises.

Participants assigned to the disease management education group, will receive online educational videos that can be watched at their own convenience over the course of 4 months. There will be up to 6 hours of content, and the links to these online videos will be provided via email. Following completion of the study, individuals in the control group will receive an Engage PD Workbook and one OT coaching session.

Eligibility criteria: Inclusion Criteria:

1. Neurologist confirmed clinical dx for Parkinson's disease Hoehn \& Yahr stage I or II
2. Ambulatory for indoor and outdoor mobility without assistance or assistive device
3. Successful completion of Physical Activity Readiness Questionnaire (PAR-Q), or medical clearance from GP

Exclusion Criteria:

1. Musculoskeletal injury that would prevent participation in an exercise program
2. Other neurological diseases or disorders such as stroke
3. Already engaging in aerobic exercise for at least 30 minutes for 5 or more days per week.

Primary outcomes:
measure: Feasibility: Adherence
timeFrame: 4 months
measure: Feasibility: Retention
timeFrame: 4 months
measure: Change from baseline Brunel Lifestyle Physical Activity Questionnaire (Karageorghis, 2005) at 4 months and 6 months
timeFrame: Baseline, 4 months, and 6 months
measure: Change From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months and 6 months
timeFrame: Baseline, 4 months, and 6 months
Secondary outcomes:
measure: Change From Baseline Timed-up-and-go (TUG) at 4 Months and 6 months
timeFrame: Baseline, 4 months, and 6 months
measure: Change From Baseline 30 second sit-to-stand at 4 Months and 6 months
timeFrame: Baseline, 4 months, and 6 months
measure: Change From Baseline Modified 2 Minute Step Test at 4 Months and 6 months
timeFrame: Baseline, 4 months, and 6 months
measure: Change From Baseline Perceived Functional Ability (PFA) Questionnaire (George et al., 1997) at 4 Months and 6 months
timeFrame: Baseline, 4 months, and 6 months
measure: Change From Baseline Modified Canadian Occupational Performance Measure (Dedding et al., 2004) at 4 Months and 6 months
timeFrame: Baseline, 4 months, and 6 months
measure: Change From Baseline Patients' Global Impression of Change scale (Hurst & Bolton, 2004) at 4 Months
timeFrame: Baseline, and 4 months
measure: Change From Baseline Life Space Assessment (Stalvey et al., 1999) at 4 Months and 6 months
timeFrame: 0, 4 & 6 months
measure: Post-Intervention Acceptability Questionnaire
timeFrame: 4 months
measure: Intervention Implementation
timeFrame: 4 months
measure: Change From Baseline Modified PA-R Questionnaire at 4 Months
timeFrame: 0 & 4 months
measure: Perceived Autonomy Support Healthcare Climate Questionnaire (HCCQ) (Williams, Freedman, & Deci, 1998):
timeFrame: 4 months
Other outcomes:
Locations:
city: San Jose
country: United States
facility: San Jose State Universty
state: California
city: New York
country: United States
facility: Neurorehabilitation Research Laboratory
state: New York
Study officials:
References: