Trials / Recruiting
RecruitingNCT06339398
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 Parkinson's Disease: a Prospective, Observational, Cohort Pilot Study
Dose-response Effects of Physical Exercise Standardized Volume on Peripheral Biomarkers, Clinical Response and Brain Connectivity in Parkinson's Disease: a Prospective, Observational, Cohort Pilot Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (estimated)
- Sponsor
- Casa di Cura San Raffaele Cassino · Network
- Sex
- All
- Age
- 30 Years – 80 Years
- Healthy volunteers
- Not accepted
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 (N=30) participants will be consecutively enrolled and assigned to 2 groups: 1) Extensive Rehabilitation Group (exercise volume: 180 METs-min/week) or 2) Intensive Rehabilitation Group (exercise volume: 1350 METs-min/week). 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-minutes/week, 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Aerobic exercise | Standardized volume of aerobic exercise, measured as METs-minutes/week |
Timeline
- Start date
- 2025-02-11
- Primary completion
- 2027-12-31
- Completion
- 2028-05-31
- First posted
- 2024-04-01
- Last updated
- 2025-02-13
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT06339398. Inclusion in this directory is not an endorsement.