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By invitation only Not applicable NCT06104397

Exercise Strategies in Parkinson's Disease

No applicable phase (e.g. observational)
Conditions: Parkinson Disease

Sponsor: Shirley Ryan AbilityLab

trial.available_in: БГ
Overview
The goal of this clinical trial is to learn about exercise and physical activity people with Parkinson's Disease. The main questions it aims to answer are: 1) learn about the physical activity and exercise behaviors of people with Parkinson's Disease over the course of a year and 2) compare 3 exercise guidance strategies aimed to impact exercise behavior: standard care, written exercise guidance from neurologist and/or physical therapy. During the course of the study: 1. Participants will use activity trackers and a mobile phone application to monitor their exercise participation. 2. At the same time, the research team will be working with the participant's medical teams at Northwestern Medicine and University of Chicago Medical Center to improve the way that they deliver exercise guidance using verbal instructions and encouragement, written exercise guidance, and/or physical therapy.
Description
The purpose of this study is to gain a better understanding of how people with Parkinson's disease (PD) manage their physical activity and exercise participation with different levels of support from their communities and clinicians. We will evaluate exercise and physical activity every 3 months in a cohort of people with PD from two medical centers in the Chicagoland area: Northwestern Medicine and University of Chicago Medical Center. During this study, we will evaluate differences in 12-month physical activity trajectories between groups enrolled during each of three conditions: (1A) standard care (condition 1, year 1), (1B) written exercise guidance (condition 2, year 2), and (1C) Consultative PT (condition 3, year 3). People with PD will be enrolled each year into an activity and exercise tracking study. Participants will be tracked using a remote therapeutic monitoring platform (Datos) and commercial grade activity trackers. Research-grade actigraphy and patient reported outcome measures will be monitored every 3 months for the first year. All participants will be enrolled in an exercise and physical activity tracking study where they can use a remote therapeutic monitoring platform (Datos Health) to share their exercise and physical activity data with their medical and rehabilitation teams at NM and UCMC. The platform allows for synchronization of patients' activity data from their fitness tracker or smartwatch to the secure cloud-based platform. The platform can summarize steps per day, activity intensity, minutes of moderate-vigorous physical activity per day based on target heart rate zones (including an ability for physical therapists to customize the target heart rate zone). At the 2 sites of care (Northwestern Medicine and University of Chicago), participants will be recruited based on contacting consecutive patients who meet the inclusion criteria based on scheduling and EMR screening prior to their visit with their neurologists. Contacting consecutive patients will ensure greater potential equity of enrolling participants rather than only patients engaged in support groups and exercise classes. However, after 3 months of recruitment, we will conduct a preliminary analysis of the numbers, recruitment rates, and characteristics (age, sex, race, ethnicity, disease duration, education) of the enrolling participants compared to the demographics of each clinic as a whole. We will then determine if we should use targeted recruitment strategies to increase reach to specific groups or recruitment rates by doing one or more of the following: (1) sending measures through MyChart to potentially eligible patients targeting or oversampling for higher socioeconomic, race, or ethnicity diversity or (2) reaching out to local community exercise classes or support groups using emails to community advocates and flyers to increase sample size more rapidly. Consecutive patients meeting the eligibility criteria will be approached by a site study team
Who can participate
Inclusion Criteria: * Have a neurologist confirmed diagnosis of Parkinson's Disease * Hoehn\&Yahr Stage 1-3 * Age 18-89 years old * Ambulatory * Written and verbal basic English proficiency adequate for survey completion * Have a smart phone * Willing to sync activity tracker with Datos health app at least every 3 days * Willing to accept Datos' Terms and Conditions Exclusion Criteria: * Diagnosis of dementia or mild cognitive impairment in medical record * Uses a rollator or rolling walker for mobility * Other comorbidities significantly limiting ability to participate in exercise \>12 weeks
Interventions
Written exercise guidance by neurologist
OTHER
Physical therapy
OTHER
Locations 3
United States (3)
Shirley Ryan AbilityLab
Chicago , Illinois
University of Chicago Medical Center
Chicago , Illinois
Northwestern Medicine
Lake Forest , Illinois
Technical details
Status
By invitation only
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
89 Years
Healthy volunteers
No
Start date
01.03.2024
Completion date
31.05.2028
Registry ID
NCT06104397
Source
clinicaltrials.gov
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