Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04922190
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2021-06-04
Brief Title:
Promoting Physical Activity Engagement for People With Early-mid Stage Parkinsons Disease Engage-PD
Sponsor:
Teachers College Columbia University
Organization:
Teachers College Columbia University
Study Overview
Official Title:
Promoting Physical Activity Engagement for People With Early-mid Stage Parkinsons Disease Engage-PD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Engage-PD
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 Parkinsons disease The program utilizes a physical or occupational therapist to provide one-on-one coaching for individuals with early-mid stage Parkinsons 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 Parkinsons disease and Huntingtons disease
Detailed Description:
Individuals will be recruited through the Columbia University Medical Center Parkinsons 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 callvideosessions 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 Clinicaltrialsgov 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 eg 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
The coaching program will utilize the Pre-Active PD program Clinicaltrialsgov 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None