Group program to manage fatigue and boost energy-conservation confidence for people with Parkinson's disease
Protocol for a Superiority Randomized Controlled Trial of a Group-Based Fatigue Management Program Versus Standard Information to Improve Self-Efficacy in Energy Conservation in Parkinson's Disease
This trial will test whether a group-based fatigue management program helps people with Parkinson's disease feel more confident using energy-conservation strategies compared with receiving standard informational sheets.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universita degli Studi di Genova Academic / other |
| Locations | 1 site (Genova) |
| Trial ID | NCT07094269 on ClinicalTrials.gov |
What this trial studies
This is a randomized, parallel-group trial in Genoa, Italy, comparing a structured, therapist-led Packer Managing Fatigue Group Program to standard fact-sheets for people with Parkinson's disease who report significant fatigue. Eligible participants are adults with idiopathic Parkinson's disease, Hoehn and Yahr stage ≤3.5, and elevated fatigue scores, and those with significant cognitive impairment or other medical causes of fatigue are excluded. The intervention is delivered by occupational therapists in group sessions and focuses on fatigue self-management and energy conservation techniques, while the control arm receives standard written information. The study is sponsored by the University of Genoa DINOGMI department and received local ethics committee approval, with recruitment planned to start July 1, 2025.
Who should consider this trial
Good fit: Ideal candidates are adults with idiopathic Parkinson's disease who speak Italian, have Hoehn and Yahr stage ≤3.5, a Fatigue Severity Scale score ≥4, MoCA ≥22, and can attend group sessions in Genoa, Italy.
Not a fit: Patients with significant cognitive impairment (MoCA <22), comorbid medical conditions that independently cause fatigue, non-idiopathic parkinsonism, or who cannot attend in-person sessions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the program could help people with Parkinson's disease use practical energy-conservation strategies and increase confidence in managing daily fatigue.
How similar studies have performed: Similar occupational therapy and energy-conservation programs have shown benefits for fatigue self-management in other neurological conditions, but rigorous evidence specifically in Parkinson's disease remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged \>18 years * diagnosis of idiopathic Parkinson's disease (PD) * Hoehn and Yahr stage ≤3.5 * Fatigue Severity Scale (FSS) \>= 4 Exclusion Criteria: * Montreal Cognitive Assessment (MoCA) score \<22 * comorbid medical conditions that could independently contribute to fatigue * not being fluent in the Italian language * Parkinsonism
Where this trial is running
Genova
- Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal Child Health (DINOGMI) University of Genoa Genoa, Italy — Genova, Italy (Recruiting)
Study contacts
- Study coordinator: Elisa Pelosin
- Email: elisa.pelosin@unige.it
- Phone: +393482609897
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.