Genetics and Aerobic Exercise to Slow Parkinson's Disease Trial

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Jay Alberts
Study ID
NCT06442033
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Aug 23, 2024
Status verified
Oct 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Interventional Arm
    All participants will exercise in a community setting 3x/week for 12 months

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Cleveland ClinicClevelandOhio44195
Elizabeth Jansen, MPH
2167809160
Anson Rosenfeldt, DPT
216-644-7617

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