Genetics and Aerobic Exercise to Slow Parkinson's Disease Trial

NCT06442033 | Recruiting DMC

• 1 other identifier: 24-100
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• MDS-UPDRS III

  Rater-observed PD global motor symptoms

  Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment

Secondary Outcomes (4)

• Nine Hole Peg Test

  Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment

• Timed Up & Go

  Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment

• Six Minute Walk Test

  Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment

• Processing Speed

  Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment

Study Arms (1)

Interventional Arm

EXPERIMENTAL

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

Other: High intensity stationary cycling

Interventions

High intensity stationary cycling OTHER

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

Interventional Arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jay Alberts: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Elizabeth Jansen, MPH

CONTACT

216-780-9160; jansena@ccf.org

Anson Rosenfeldt, DPT

CONTACT

216-644-7617; rosenfa2@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: A historical control group will be utilized for analysis from a previous project. All participants in this study will be exercising in the community setting.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Center Director

Model Details: Single Group

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: August 23, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)