Actively Recruiting
Dose-response Effects of Physical Exercise Volume on Biomarkers, Clinical Response, and Brain Connectivity in Parkinson's Disease: An Observational Cohort Pilot Study
Led by Casa di Cura San Raffaele Cassino · Updated on 2025-02-13
30
Participants Needed
1
Research Sites
21 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
Researchers are studying how different amounts of aerobic exercise affect brain-derived neurotrophic factor (BDNF) levels in people with Parkinson's disease. This pilot observational study compares two rehabilitation exercise programs with different energy expenditures to see how they influence BDNF and other biomarkers, motor and non-motor symptoms, brain activity, and connectivity. The goal is to understand the dose-response relationship between exercise volume and these changes. Participants are divided into two groups: the Extensive Rehabilitation Group will perform 45-minute sessions of low-intensity aerobic exercise twice a week, totaling 180 METs-minutes per week. The Intensive Rehabilitation Group will do 45-minute sessions of high-intensity aerobic exercise five days a week, reaching 1350 METs-minutes per week. Both exercise programs last for 4 weeks. During the study, participants will undergo blood tests to measure BDNF and other peripheral biomarkers at 4, 8, and 12 weeks. Researchers will also assess motor symptoms, cognitive function, quality of life, gait parameters, cortical activity using EEG, and brain connectivity with fMRI. The study involves monitoring changes over time to evaluate how exercise intensity influences these health markers in Parkinson's disease patients.
CONDITIONS
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 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
- Age between 30 and 80 years
- Disease stage II-III in "ON" phase according to modified Hoehn and Yahr (H&Y)
- No severe cognitive impairment: Mini-Mental State Examination-MMSE ≥24 and Montreal Cognitive Assessment - MoCA ≥17/30
- 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 program execution
- Known cardiovascular disease compromising protocol performance
- Presence of diabetes or other metabolic/endocrine diseases
- Uncontrolled hypertension (resting blood pressure >150/90 mmHg)
- Orthostatic hypotension with systolic pressure in feet below 100 or significant drop upon standing
- Hypo- or hyperthyroidism (TSH <0.5 or >5.0 mU/L), abnormal liver or kidney function
- Clinically significant abnormal blood test values
- Recent unstable use of psychotropic drugs (last 28 days)
- Severe disease requiring systemic treatment or hospitalization in last 4 weeks
- Other medical, psychiatric, or substance abuse conditions interfering with participation
- Beck Depression Inventory II (BDI) score >28 indicating severe depression
- Pregnancy (women only)
- Other disorders or injuries interfering with exercise ability (e.g., stroke, breathing problems, brain injury, orthopedic or neuromuscular disease)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants perform aerobic exercise according to their assigned rehabilitation group: either low-intensity aerobic exercise twice a week or high-intensity aerobic exercise five days per week, each for a 4-week period. This stage includes assessments of peripheral biomarkers, motor and non-motor symptoms, cognitive function, and brain activity.
Weekly visits for up to 4 weeks
Duration - 8 weeks
Participants are monitored for changes in biomarkers, clinical symptoms, cognitive function, and brain connectivity up to 12 weeks after the exercise period.
Follow-up visits at Weeks 8 and 12
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
M
Maria Gaglione
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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