Recruiting

Genetics & Exercise

Sponsor:

Jay Alberts

Code:

NCT06442033

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High intensity stationary cycling

Study Details

Brief summary:

The proposed multi-site, Genetics and Aerobic Exercise to Slow PD (GEARS) Trial will, for the first time, determine the interplay between genetics and exercise in altering PD progression. In sum, 200 PD patients will be recruited from the Cleveland and Salt Lake City metro areas to participate in the Pedaling for Parkinson's (PFP) community-based exercise program. Participants will exercise at community-based sites 3x/week for 12 months. All participants will undergo genotyping using an array that includes the genome backbone and common risk variants associated to increase risk for multiple neurological disorders including PD.

Conditions

Parkinson Disease

Study ID

NCT06442033

Start date

Aug 23, 2024

Status verified date

Aug, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Interventional Arm

All participants will exercise in a community setting 3x/week for 12 months

Interventions

High intensity stationary cycling

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

Primary outcome measure

  • MDS-UPDRS III [ Time Frame: Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment ]

Central Contacts and Locations

Central contacts

Elizabeth Jansen, MPH

216-780-9160jansena@ccf.org

Anson Rosenfeldt, DPT

216-644-7617rosenfa2@ccf.org

Locations

The Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Elizabeth Jansen, MPH

2167809160jansena@ccf.org

Anson Rosenfeldt, DPT

216-644-7617rosenfa2@ccf.org

More Information

Sponsor

Jay Alberts

Last update posted

Aug 21, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jay Alberts on 2026-08-21.