Exercise Strategies in Parkinson's Disease

NCT06104397 | Enrolling By Invitation DMC

• 2 other identifiers: STU002191161R01HD110668-01
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 3

Brief Summary

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. 1.Participants will use activity trackers and a mobile phone application to monitor their exercise participation.
2. 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.

Conditions

Parkinson Disease

Keywords

Exercise; Physical Activity; Physical Therapy; Activity Monitoring

Outcome Measures

Primary Outcomes (1)

• Accelerometer Measures

  Minutes per day of moderate to vigorous physical activity (MVPA)

  Average 1-week MVPA measured every 3-months throughout 12-month study period

Secondary Outcomes (1)

• Steps per Day

  Average 1-week step counts measured every 3-months throughout 12-month study period

Study Arms (3)

Standard Care

NO INTERVENTION

Standard care patient's with Parkinson's Disease are receiving at each site.

Written exercise guidance by neurologist

ACTIVE COMPARATOR

Neurologists will provide written exercise education and guidance to their patients with Parkinson's Disease.

Other: Written exercise guidance by neurologist

Physical therapy

EXPERIMENTAL

A consultative model of physical therapy will be implemented at each site for patient's with Parkinson's Disease.

Other: Physical therapy

Interventions

Written exercise guidance by neurologist OTHER

Neurologists will provide written exercise education and guidance to their patients with Parkinson's Disease during neurologist visits and/or in after visit summary in the patient's EMR patient portal. The research team will facilitate the development of the written exercise guidance with input and feedback from each site's neurology, clinical, and administrative teams.

Written exercise guidance by neurologist

Physical therapy OTHER

A consultative model of physical therapy - a lower dose of physical therapy focused on physical activity and exercise promotion and coaching - will be implemented into each site. In the consultative model of physical therapy, visits are scheduled around needs of the patient, however will involve 1-4 additional visits within 3 months of evaluation and is based on personal factors that influence their exercise prognosis such as self-efficacy, readiness to change, fitness level, age, health literacy, comorbidities, and Parkinson's Disease-related motor and non-motor impairments.

Physical therapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• University of Chicago: collaborator
• Northwestern Medicine: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Northwestern Medicine

Lake Forest, Illinois, 60045, United States

Location

Related Publications (3)

• Osborne JA, Botkin R, Colon-Semenza C, DeAngelis TR, Gallardo OG, Kosakowski H, Martello J, Pradhan S, Rafferty M, Readinger JL, Whitt AL, Ellis TD. Physical Therapist Management of Parkinson Disease: A Clinical Practice Guideline From the American Physical Therapy Association. Phys Ther. 2022 Apr 1;102(4):pzab302. doi: 10.1093/ptj/pzab302. Erratum In: Phys Ther. 2022 Aug 1;102(8):pzac098. doi: 10.1093/ptj/pzac098.

  PMID: 34963139 BACKGROUND

• Rafferty MR, MacDonald J, Byskosh A, Sloan L, Toledo S, Marciniak C, Simuni T. Using Implementation Frameworks to Provide Proactive Physical Therapy for People With Parkinson Disease: Case Report. Phys Ther. 2019 Dec 16;99(12):1644-1655. doi: 10.1093/ptj/pzz129.

  PMID: 31508801 BACKGROUND

• Cavanaugh JT, Ellis TD, Earhart GM, Ford MP, Foreman KB, Dibble LE. Capturing ambulatory activity decline in Parkinson's disease. J Neurol Phys Ther. 2012 Jun;36(2):51-7. doi: 10.1097/NPT.0b013e318254ba7a.

  PMID: 22592060 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Miriam Rafferty, PT, DPT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Implementation Science

Model Details: There are 3 treatment groups: 1) standard care, 2) written exercise guidance by neurologists, and 3) physical therapy.

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data will become available following completion and analysis of research study data. Data will be stored in our laboratory data repository system and thus will be available indefinitely.
• Access Criteria: Data summaries will be publicly available on the Shirley Ryan AbilityLab website and Northwestern University DigitalHub. De-identified data will, also, be shared in the Data and Specimen Hub (DASH) through the NICHD.

Locations

US (3)