Group program to manage fatigue and boost energy-conservation confidence for people with Parkinson's disease
Official title: 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
Run by Universita degli Studi di Genova · NCT07094269 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Universita degli Studi di Genova Academic / other |
| Locations | 1 site (Genova) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | September 1, 2026 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT07094269 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.