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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

NCT06339398 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-02-13

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

BEHAVIORAL

Aerobic exercise

Standardized volume of aerobic exercise, measured as METs-minutes/week

Sponsors & Collaborators

  • IRCCS San Raffaele Roma

    collaborator OTHER

  • San Raffaele Telematic University

    collaborator OTHER

  • University of Rome Tor Vergata

    collaborator OTHER

  • University of Urbino "Carlo Bo"

    collaborator OTHER

  • Casa di Cura San Raffaele Cassino

    lead NETWORK

Principal Investigators

  • Maria Francesca De Pandis, MD,PhD · San Raffaele Cassino

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-11
Primary Completion
2027-12-31
Completion
2028-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06339398 on ClinicalTrials.gov