Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442033
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-05-29
Brief Title:
Genetics and Aerobic Exercise to Slow Parkinsons Disease Trial
Sponsor:
Jay Alberts
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Genetics and Aerobic Exercise to Slow Parkinsons Disease GEARS Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEARS
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 Parkinsons PFP community-based exercise program Participants will exercise at community-based sites 3xweek 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
Detailed Description:
A long-standing unmet need in the treatment of Parkinsons disease PD is the identification of a disease-modifying intervention eg 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 geneticbiological burden Genetic burden for PD will be determined through the calculation of a PD polygenic risk score PRS
Total study duration is 125 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 ones 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 3xwk at the community center most convenient to them Participants will be recruited and enrolled on a continuous basis
Total study duration is 125 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 ones 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 3xwk at the community center most convenient to them Participants will be recruited and enrolled on a continuous basis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None