Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT02676804
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2016-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Dosing Trial for Individuals With Parkinson's Disease
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
Exercise Dosing Trial for Individuals With Parkinson's Disease
Status:
COMPLETED
Status Verified Date:
2022-11
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:
PDEX
Brief Summary:
This is a prospective, pre-post intervention study to evaluate the effect of a high-intensity, aerobic exercise program on outcomes of cognition, mood, gait, balance, cardiorespiratory fitness, neuromuscular performance, fatigue, sleep, and quality of life for patients diagnosed with idiopathic Parkinson disease. The primary outcomes will be a composite measure of cognitive function and the Timed Up and Go (TUG).
Detailed Description:
All subjects will be assigned to aerobic exercise that will use a blend of both unsupervised moderate and supervised high intensity exercise. The exercise will consist of walking / jogging modalities, dependent on the individual's level of bradykinesia and will be paced by the individual's level of perceived exertion. The exercise protocol will be designed to target an accumulation of at least 150 minutes of cardiovascular exercise per week.
Exercise training will be performed 5x/week for a total of 16 weeks. The training will consist of 3 supervised high intensity sessions and 2 at home moderate intensity exercise sessions. The high intensity sessions will be performed on a treadmill at an intensity rating of \~ 15 and 17 on a rating of perceived exertion (RPE) scale of 6 to 20. The moderate intensity exercise will target an RPE of \~10 - 12 and participants will be asked to complete this on their own.
Exercise training will be performed 5x/week for a total of 16 weeks. The training will consist of 3 supervised high intensity sessions and 2 at home moderate intensity exercise sessions. The high intensity sessions will be performed on a treadmill at an intensity rating of \~ 15 and 17 on a rating of perceived exertion (RPE) scale of 6 to 20. The moderate intensity exercise will target an RPE of \~10 - 12 and participants will be asked to complete this on their own.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: