Actively Recruiting
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
Led by Casa di Cura San Raffaele Cassino · Updated on 2025-02-13
30
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
Sponsors
C
Casa di Cura San Raffaele Cassino
Lead Sponsor
I
IRCCS San Raffaele Roma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official 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 Parkinson's Disease: a Prospective, Observational, Cohort Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Parkinson's Disease according to the United Kingdom (UK) Parkinson's Disease Society Brain Bank
- Aged between 30 and 80 years
- Disease stage II-III in "ON" phase according to modified Hoehn and Yahr (H&Y)
- Mini-Mental State Examination (MMSE) score of 24 or higher
- Montreal Cognitive Assessment (MoCA) score of 17 or higher
- Under stable dopaminergic pharmacological treatment
- Motor condition permits execution of 6-Minutes Walking Test (6MWT)
- Willing to participate, understand procedures, and sign informed consent
You will not qualify if you...
- Diagnosis of neurological disorders not related to Parkinson's disease
- Musculoskeletal diseases impairing gait or exercise execution
- Known cardiovascular disease compromising protocol performance
- Diabetes or other metabolic and endocrine diseases
- Uncontrolled hypertension (resting blood pressure >150/90 mmHg)
- Orthostatic hypotension with systolic pressure in feet below 100 or blood pressure drop criteria
- Hypo- or hyperthyroidism (TSH <0.5 or >5.0 mU/L)
- Abnormal liver function (AST or ALT more than 2 times upper limit of normal)
- Altered kidney function
- Clinically significant abnormal blood test values
- Recent unstable use of psychotropic drugs within 28 days before screening
- Severe disease requiring systemic treatment or hospitalization in last 4 weeks
- Any other clinically significant medical, psychiatric condition, substance abuse, or lab abnormality interfering with participation
- Beck Depression Inventory II (BDI) score > 28 indicating severe depression
- Pregnancy (for women only)
- Other disorders or injuries interfering with exercise ability (e.g., stroke, breathing problems, traumatic brain injury, orthopedic injury, neuromuscular disease)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
San Raffaele Cassino
Cassino, Frosinone, Italy, 03043
Actively Recruiting
Research Team
M
Maria Francesca De Pandis, MD, PhD
CONTACT
M
Maria Gaglione
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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