Exploring physical activity as a potential treatment for Parkinson's disease
Physical Activity in Patients With Parkinson's Disease: a "Disease Modifying" Intervention?
This study is testing if regular physical activity can help people with Parkinson's disease feel better and slow down the progression of their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 45 Years to 70 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT05815524 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of physical activity training on patients diagnosed with Parkinson's disease. It aims to determine whether engaging in structured physical activity can modify the disease's progression and improve patient outcomes. Participants will be carefully selected based on specific inclusion and exclusion criteria, ensuring a focus on those with stable conditions and appropriate health status. The study seeks to address the challenges of predicting treatment responses and understanding disease pathogenesis in Parkinson's disease.
Who should consider this trial
Good fit: Ideal candidates are patients aged 45-70 with a diagnosis of Parkinson's disease in Hoehn & Yahr stages 1-3 who have been on stable dopaminergic therapy.
Not a fit: Patients with serious orthopedic issues, severe psychiatric disorders, or those who regularly engage in high levels of physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved management and potentially slower progression of Parkinson's disease for patients.
How similar studies have performed: While the approach of using physical activity as a therapeutic intervention is gaining traction, this specific study's focus on disease modification in Parkinson's disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with PD defined according to MDS criteria * Hoehn \& Yahr Stage 1-3 * Stable dopaminergic therapy in the previous month * Duration of disease of at least 3 years * MMSE \> 24/30 * Age between 45-70 years * Signature of the informed consent to participate in the study in question Exclusion Criteria: * Contraindications to the practice of physical activity as required by the European Society of Cardiology 2020 guidelines * Practice of regular sporting activity for more than 150 minutes per week * Serious orthopedic pathologies * Severe psychiatric disorders * Inflammatory or autoimmune diseases * Active oncological pathologies * Known cardiovascular and/or cardiorespiratory pathologies that may contraindicate or influence the performance of the motor program (ischaemic heart disease, arterial hypertension not under pharmacological treatment, primary or secondary non-Parkinson-related cardiomyopathies and/or valve diseases, channelopathies, anemia, heart failure, COPD pulmonary hypertension, bronchial asthma).
Where this trial is running
Roma
- Flavia Torlizzi — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Giulia Di Lazzaro, MD
- Email: giulia.dilazzaro@policlinicogemelli.it
- Phone: +390630156433
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.