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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Physical Activity Coaching
Sponsored by
Teachers College, Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring physical activity, exercise, rehabilitation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Teachers College, Columbia UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical Activity Coaching

Arm Description

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.

Outcomes

Primary Outcome Measures

Brunel Lifestyle Physical Activity Questionnaire
The Brunel lifestyle inventory is a 10-item questionnaire that measures both pre-planned (6 items) and un-planned (3 items) lifestyle PA. Scoring for each item is on a scale of 1-5, and the scores for each subscale are averaged. Scores range from 1 (low level of physical activity) to 5 (high level of physical activity).
Self-Efficacy for Exercise Scale
18-item test that measures an individual's self-efficacy to participate in exercise when numerous barriers are present, including both social and physical barriers. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.

Secondary Outcome Measures

International Physical Activity Questionnaire (Short-Form Phone version)
Evaluates physical activity over the previous 7 days represented in MET/min per week with higher values meaning greater physical activity.
NeuroQOL
Patient-reported questionnaire evaluating sleep disturbances, depression, fatigue and social participation and satisfaction.
Brief Pain Inventory
Evaluates the presence of pain including intensity and interference with activities of daily living. Mean of the four severity items is used as measures of pain severity; the mean of the seven interference items is used as a measure of pain interference.
Timed Up and Go
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. Outcome is measured in time (sec) to complete and higher value is worse performance.
Standing balance assessment
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
Questionnaire evaluating how back pain affects everyday life (optional for those participants who report low back pain). Range 0-50 with 50 being higher level of disability.
Acceptability questionnaire (open-ended questions)
A short open-ended questionnaire to assess the acceptability of the intervention. These open-ended questions will be analyzed qualitatively.

Full Information

First Posted
June 4, 2021
Last Updated
October 19, 2022
Sponsor
Teachers College, Columbia University
Collaborators
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT04922190
Brief Title
Promoting Physical Activity Engagement for People With Early-mid Stage Parkinson's Disease (Engage-PD)
Acronym
Engage-PD
Official Title
Promoting Physical Activity Engagement for People With Early-mid Stage Parkinson's Disease (Engage-PD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2020 (Actual)
Primary Completion Date
March 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teachers College, Columbia University
Collaborators
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
physical activity, exercise, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity Coaching
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Physical Activity Coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brunel Lifestyle Physical Activity Questionnaire
Description
The Brunel lifestyle inventory is a 10-item questionnaire that measures both pre-planned (6 items) and un-planned (3 items) lifestyle PA. Scoring for each item is on a scale of 1-5, and the scores for each subscale are averaged. Scores range from 1 (low level of physical activity) to 5 (high level of physical activity).
Time Frame
3 months
Title
Self-Efficacy for Exercise Scale
Description
18-item test that measures an individual's self-efficacy to participate in exercise when numerous barriers are present, including both social and physical barriers. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
International Physical Activity Questionnaire (Short-Form Phone version)
Description
Evaluates physical activity over the previous 7 days represented in MET/min per week with higher values meaning greater physical activity.
Time Frame
3 months
Title
NeuroQOL
Description
Patient-reported questionnaire evaluating sleep disturbances, depression, fatigue and social participation and satisfaction.
Time Frame
3 months
Title
Brief Pain Inventory
Description
Evaluates the presence of pain including intensity and interference with activities of daily living. Mean of the four severity items is used as measures of pain severity; the mean of the seven interference items is used as a measure of pain interference.
Time Frame
3 months
Title
Timed Up and Go
Description
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. Outcome is measured in time (sec) to complete and higher value is worse performance.
Time Frame
3 months
Title
Standing balance assessment
Description
Participant will perform static standing with feet together and postural sway will be recorded with a smartphone app.
Time Frame
3 months
Title
Modified Oswestry Low Back Pain Disability Questionnaire
Description
Questionnaire evaluating how back pain affects everyday life (optional for those participants who report low back pain). Range 0-50 with 50 being higher level of disability.
Time Frame
3 months
Title
Acceptability questionnaire (open-ended questions)
Description
A short open-ended questionnaire to assess the acceptability of the intervention. These open-ended questions will be analyzed qualitatively.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Teachers College, Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Quinn, EdD, PT
Phone
212-678-3424
Email
lq2165@tc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Miriam King, MA
Phone
212-678-3916
Email
mk4343@tc.columbia.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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