Exploring how genetics and exercise can slow Parkinson's disease progression
Genetics and Aerobic Exercise to Slow Parkinson's Disease (GEARS) Trial
This study is testing if high-intensity cycling can help slow down Parkinson's disease for people based on their genetics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06442033 on ClinicalTrials.gov |
What this trial studies
The Genetics and Aerobic Exercise to Slow Parkinson's Disease Trial aims to investigate the relationship between genetics and high-intensity aerobic exercise in altering the progression of Parkinson's disease. This multi-site trial will recruit 200 patients from Cleveland and Salt Lake City to participate in a community-based exercise program, 'Pedaling for Parkinson's', where they will engage in cycling three times a week for 12 months. Participants will undergo genetic testing to assess their polygenic risk scores, which will help determine how genetic factors influence the effectiveness of exercise in slowing disease progression. The study includes multiple assessments to evaluate the impact of exercise on Parkinson's symptoms while considering the genetic background of the participants.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with Parkinson's disease who are in Hoehn and Yahr stages I-III and can safely participate in high-intensity cycling.
Not a fit: Patients with dementia or significant neurocognitive impairment, as well as those undergoing other disease-modifying treatments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into personalized exercise regimens that may significantly slow the progression of Parkinson's disease.
How similar studies have performed: While there is evidence supporting the benefits of exercise in controlled settings, this study's focus on community-based exercise and genetic factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult with a diagnosis of PD by a physician or physician extender 2. Hoehn and Yahr stage I-III 3. Demonstrate the ability to safely mount and dismount a stationary cycle 4. Reliable transportation to the community exercise facility 5. Smartphone device for activity data monitoring 6. On a stable dose of anti-parkinsonian medication Exclusion Criteria: 1. Participation in disease modifying PD-related clinical trial or study 2. Diagnosis of dementia or any neurocognitive impairment that compromises one's ability to provide informed consent. 3. Implanted deep brain stimulation electrodes or focused ultrasound for PD management 4. 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
Where this trial is running
Cleveland, Ohio
- The Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Elizabeth Jansen, MPH
- Email: jansena@ccf.org
- Phone: 216-780-9160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.