Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339398
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-01
First Post:
2024-03-25
Brief Title:
To Evaluate the Dose-response Effects of a Defined Volume of Physical Exercise on the Change of Peripheral Biomarkers Clinical Response and Brain Connectivity in Parkinsons Disease a Prospective Observational Cohort Pilot Study
Sponsor:
Casa di Cura San Raffaele Cassino
Organization:
Casa di Cura San Raffaele Cassino
Study Overview
Official Title:
Dose-response Effects of Physical Exercise Standardized Volume on Peripheral Biomarkers Clinical Response and Brain Connectivity in Parkinsons Disease a Prospective Observational Cohort Pilot Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
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:
METEX-PD
Brief Summary:
This is a prospective observational cohort pilot study of standardize volume of aerobic exercise on changes in BDNF concentration at 4-weeks of exercise training among Parkinson disease patients
Thirty N30 participants will be consecutively enrolled and assigned to 2 groups 1 Extensive Rehabilitation Group exercise volume 180 METs-minweek or 2 Intensive Rehabilitation Group exercise volume 1350 METs-minweek
The primary objective is to evaluate the dose-response effects of two different rehabilitation settings characterized by different workload measured as energy expenditure on blood BDNF levels
Thirty N30 participants will be consecutively enrolled and assigned to 2 groups 1 Extensive Rehabilitation Group exercise volume 180 METs-minweek or 2 Intensive Rehabilitation Group exercise volume 1350 METs-minweek
The primary objective is to evaluate the dose-response effects of two different rehabilitation settings characterized by different workload measured as energy expenditure on blood BDNF levels
Detailed Description:
This pilot observational study will evaluate the dose-response relationship between the volume of exercise measured as METs-minutesweek of two different rehabilitation settings to quantify the change in BDNF concentration in PD patients
The study will also compare the changes induced by extensive and intensive rehabilitation settings in other neurotrophic factors and peripheral biomarkers on motor and non-motor symptoms kinematic parameters of gait cognitive function quality of life and the changes in cortical activity assessed with electroencephalogram EEG and in brain connectivity by functional magnetic resonance imaging fMRI
The study will also compare the changes induced by extensive and intensive rehabilitation settings in other neurotrophic factors and peripheral biomarkers on motor and non-motor symptoms kinematic parameters of gait cognitive function quality of life and the changes in cortical activity assessed with electroencephalogram EEG and in brain connectivity by functional magnetic resonance imaging fMRI
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