Evaluating the effects of exercise on biomarkers and brain connectivity in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational pilot study aims to assess how different volumes of aerobic exercise impact blood levels of brain-derived neurotrophic factor (BDNF) and other biomarkers in patients with Parkinson's disease. Thirty participants will be divided into two groups, one receiving extensive rehabilitation and the other intensive rehabilitation, over a four-week period. The study will also evaluate changes in motor and non-motor symptoms, cognitive function, quality of life, and brain activity using EEG and fMRI. The goal is to understand the dose-response relationship between exercise and various health outcomes in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)
* Having no severe cognitive impairment:

  * Mini-Mental State Examination-MMSE ≥24
  * Montreal Cognitive Assessment - MoCA ≥ 17/30
* Under stable dopaminergic pharmacological treatment
* Motor condition that permits to execute 6-Minutes Walking Test (6MWT)
* Willing to participate in the study, understand the procedures and sign the informed consent.

Exclusion Criteria:

* Diagnosis of neurological disorders not related to Parkinson's disease
* Musculoskeletal diseases that could impair gait and execution of exercise program
* Presence of known cardiovascular disease that can compromise the performance required by the protocol
* Presence of diabetes or other metabolic and endocrine disease
* Uncontrolled hypertension (resting blood pressure \>150/90 mmHg)
* Individuals with orthostatic hypotension and systolic pressure in feet below 100 will be excluded. Orthostatic hypotension (OH) is a reduction in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg within 3 minutes of standing.
* Hypo- or hyperthyroidism (TSH \<0.5 or \>5.0 mU/L), abnormal liver function (AST or ALT more than 2 times the upper limit of normal, ULN), alteration of kidney function.
* Values of complete blood test out of range and abnormal value clinically significant as per clinical judgment.
* Recent use of psychotropic drugs (e.g. anxiolytics, hypnotics, benzodiazepines, antidepressants) in which the dosage was not stable for 28 days before screening
* Severe disease (requiring systemic treatment and/or hospitalization) in the last 4 weeks.
* Any other clinically significant medical condition, psychiatric condition, drug or alcohol abuse, laboratory evaluation or abnormality that, in the opinion of the investigators, would interfere with the subject's ability to participate in the study.
* Beck Depression Inventory II (BDI) score \> 28, indicating a severe depression that precludes the ability to exercise.
* (Only for women) State of pregnancy.
* Other disorders, injuries, diseases or conditions that may interfere with the ability to perform exercises (e.g. history of stroke, breathing problems, traumatic brain injury, orthopaedic injury or neuromuscular disease).

Where it's running

• San Raffaele Cassino
  Cassino, Frosinone, Italy Recruiting

Study contacts

• Principal investigator: Maria Francesca De Pandis, MD,PhD — San Raffaele Cassino
• Study coordinator: Maria Francesca De Pandis, MD, PhD
• Email: maria.depandis@sanraffaele.it
• Phone: 0039 0776394740

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.