- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06442033
Genetics and Aerobic Exercise to Slow Parkinson's Disease Trial (GEARS)
Genetics and Aerobic Exercise to Slow Parkinson's Disease (GEARS) Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A long-standing unmet need in the treatment of Parkinson's disease (PD) is the identification of a disease-modifying intervention (e.g. pharmaceutical, surgical or behavioral). A growing body of evidence indicates that high-intensity aerobic exercise, when delivered in a highly supervised, well-controlled laboratory setting, improves PD symptomology. Two fundamental gaps remain related to the widespread utilization of exercise to slow PD: 1) are community-based exercise programs effective in altering disease progression and 2) what is the role of genetics in modulating the disease altering effects of high-intensity aerobic exercise? Our underlying hypothesis is that high-intensity, community-based exercise slows disease progression in PD and does so more effectively in individuals with a lower genetic/biological burden. Genetic burden for PD will be determined through the calculation of a PD polygenic risk score (PRS).
Total study duration is ~12.5 months to accommodate data collection sessions and enrollment in PFP class. The study consists of five in-person assessments at the Cleveland Clinic or the University of Utah: informed consent, enrollment (On- and Off-medication separated by at least 24 hrs), 6 months (Off-medication), and 12 months (Off-medication). Asking participants to withhold medication for Off-state examinations imposes a burden, but the Off-state (12 hours off meds) will increase insight into the direct effect of exercise on PD and provides more reliable, less confounded time comparisons. Antiparkinsonian medication will be reconciled at Baseline, 6- and 12-month timepoints. Outcome metrics are provided in Table 1. Notably, all outcome metrics will be collected at each time point after the consent appointment (baseline on, baseline off, 6 month and 12 month) with the exception of the quality of life metrics (Neuro-QoL and MDS-UPDRS I, II, IV) which will be collected at one of the two baseline assessments (instead of both baseline assessments), 6 month, and 12 month; the quality of life questionnaires ask questions about one's quality of life over the previous 7 days and are non-specific to medication state. Genetic data and demographics will be gathered at the first enrollment assessment visit. Following the two enrollment visits, the participant will begin attending PFP classes 3x/wk at the community center most convenient to them. Participants will be recruited and enrolled on a continuous basis.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Elizabeth Jansen, MPH
- Phone Number: 216-780-9160
- Email: jansena@ccf.org
Study Contact Backup
- Name: Anson Rosenfeldt, DPT
- Phone Number: 216-644-7617
- Email: rosenfa2@ccf.org
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult with a diagnosis of PD by a physician or physician extender
- Hoehn and Yahr stage I-III
- Demonstrate the ability to safely mount and dismount a stationary cycle
- Reliable transportation to the community exercise facility
- Smartphone device for activity data monitoring
- On a stable dose of anti-parkinsonian medication
Exclusion Criteria:
- Participation in disease modifying PD-related clinical trial or study
- Diagnosis of dementia or any neurocognitive impairment that compromises one's ability to provide informed consent.
- Implanted deep brain stimulation electrodes or focused ultrasound for PD management
- Recommendation for medical clearance using the American College of Sports Medicine (ACSM) Preparticipation Health Screen a. If the ACSM screen recommends medical clearance, the participant must obtain medical clearance by their health care provider prior to participation.
b. Those who choose not to obtain physician clearance will not be eligible for participation.
e) A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in a cycling intervention f) Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke) g) Current cardiac arrhythmia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interventional Arm
All participants will exercise in a community setting 3x/week for 12 months
|
All community based exercise sessions are: 3x/week for 40 min, which includes a 5-min warm up & cool down and a 30-minute main exercise set.
Exercise parameters will be set by a neurologically trained physical therapist and will be progressed over time with the ultimate goal of the individual reaching moderate-vigorous exercise.
Moderate-vigorous exercise for this project is defined as a cadence of 75+ rpms and a target HR of 60-80% of their age-predicted max
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MDS-UPDRS III
Time Frame: Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment
|
Rater-observed PD global motor symptoms
|
Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nine Hole Peg Test
Time Frame: Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment
|
Upper extremity dexterity
|
Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment
|
Timed Up & Go
Time Frame: Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment
|
Sit to stand from chair, ambulate 3m, turn, return to chair and sit
|
Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment
|
Six Minute Walk Test
Time Frame: Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment
|
Cardiovascular Fitness
|
Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment
|
Processing Speed
Time Frame: Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment
|
Symbol/digit matching; test of information processing speed, implicit learning
|
Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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