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

Overview

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.

Full Title of Study: “Promoting Physical Activity Engagement for People With Early-mid Stage Parkinson’s Disease (Engage-PD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 15, 2023

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.

Interventions

  • Behavioral: 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.

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Brunel Lifestyle Physical Activity Questionnaire
    • Time Frame: 3 months
    • Evaluates both pre-planned and unplanned physical activity and will be administered during the baseline assessment to evaluate current levels of physical activity.
  • Self-Efficacy for Exercise Scale
    • Time Frame: 3 months
    • Assesses an individual’s beliefs in their ability to engage in exercise on a consistent basis in the future

Secondary Measures

  • International Physical Activity Questionnaire (Short-Form Phone version)
    • Time Frame: 3 months
    • Evaluates physical activity over the previous 7 days.
  • NeuroQOL
    • Time Frame: 3 months
    • Patient-reported questionnaire evaluating sleep disturbances, depression, fatigue and social participation and satisfaction
  • Brief Pain Inventory
    • Time Frame: 3 months
    • Evaluates the presence of pain including intensity and interference with activities of daily living.
  • Timed Up and Go
    • Time Frame: 3 months
    • Performance-based assessment which requires a person to stand up from a chair, walk 10 feet, turn around, return to their chair and sit back down
  • Standing balance assessment
    • Time Frame: 3 months
    • Participant will perform static standing with feet together and postural sway will be recorded with a smartphone app.
  • Modified Oswestry Low Back Pain Disability Questionnaire
    • Time Frame: 3 months
    • Questionnaire evaluating how back pain affects everyday life (optional for those participants who report low back pain)
  • Acceptability questionnaire
    • Time Frame: 3 months
    • A short questionnaire to assess the acceptability of the intervention

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Teachers College, Columbia University
  • Collaborator
    • Columbia University
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.