Promoting Physical Activity Engagement for People With Early-mid Stage Parkinson's Disease (Engage-PD)

NCT ID: NCT04922190

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-15
• Study Completion Date: 2024-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical Activity Coaching

Participants will receive up to 5 coaching sessions by a physical or occupational therapist. The intervention will focus on facilitating physical activity engagement and development of specific and measurable goals. The recommended program 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. At the follow up sessions the therapist will review progress with the current exercise plan and progress and discuss barriers and facilitators for exercise engagement. Participants will have the option to use a Fitbit or other device to monitor their heart rate and physical activity during the course of the intervention period.

Group Type: EXPERIMENTAL

Physical Activity Coaching

Intervention Type: BEHAVIORAL

Participants will receive up to 5 coaching sessions by a physical or occupational therapist. The intervention will focus on facilitating physical activity engagement and development of specific and measurable goals. The recommended program 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. At the follow up sessions the therapist will review progress with the current exercise plan and progress and discuss barriers and facilitators for exercise engagement. Participants will have the option to use a Fitbit or other device to monitor their heart rate and physical activity during the course of the intervention period.

Interventions

Physical Activity Coaching

Participants will receive up to 5 coaching sessions by a physical or occupational therapist. The intervention will focus on facilitating physical activity engagement and development of specific and measurable goals. The recommended program 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. At the follow up sessions the therapist will review progress with the current exercise plan and progress and discuss barriers and facilitators for exercise engagement. Participants will have the option to use a Fitbit or other device to monitor their heart rate and physical activity during the course of the intervention period.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

Teachers College, Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Teachers College, Columbia University

New York, New York, United States

Countries

United States

Other Identifiers

20-005

Identifier Type: -

Identifier Source: org_study_id