Evaluating the effects of exercise on biomarkers and brain connectivity in Parkinson's disease
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
Casa di Cura San Raffaele Cassino · NCT06339398
This study is testing how different amounts of aerobic exercise can affect brain health and overall well-being in people with Parkinson's disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Casa di Cura San Raffaele Cassino (network) |
| Locations | 1 site (Cassino, Frosinone) |
| Trial ID | NCT06339398 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 30 to 80 with a diagnosis of Parkinson's disease in stages II-III who are stable on dopaminergic treatment.
Not a fit: Patients with severe cognitive impairment, other neurological disorders, or significant cardiovascular or musculoskeletal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how tailored exercise regimens can improve health outcomes for patients with Parkinson's disease.
How similar studies have performed: Other studies have shown promising results in the effects of exercise on Parkinson's disease, but this specific dose-response approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cassino, Frosinone
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson Disease, Physical exercise, Brain-derived neurotrophic factor