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


Sponsor

Casa di Cura San Raffaele Cassino

Enrollment

30 participants

Start Date

Feb 11, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 30 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This observational pilot study examines how different doses of physical exercise affect brain function, blood markers, and movement in people with Parkinson's disease. It aims to understand the "dose-response" relationship between exercise and the brain, potentially informing personalized exercise prescriptions. **You may be eligible if...** - You have been diagnosed with Parkinson's disease (per UK Parkinson's Disease Society Brain Bank criteria) - You are between 30 and 80 years old - Your Parkinson's is in stages II–III (moderate), while your medication is working - You have adequate cognitive function (MMSE ≥ 24 and MoCA ≥ 17/30) - You are on a stable Parkinson's medication regimen - You are physically able to walk for a 6-minute walk test **You may NOT be eligible if...** - You have another neurological condition unrelated to Parkinson's - You have musculoskeletal problems that impair walking or exercise - You have significant cardiovascular disease, diabetes, uncontrolled high blood pressure, or thyroid/kidney/liver abnormalities - You have orthostatic hypotension (blood pressure drops significantly when you stand up) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALAerobic exercise

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


Locations(1)

San Raffaele Cassino

Cassino, Frosinone, Italy

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NCT06339398


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