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Protocol of the Packer Managing Fatigue Program Versus Standard Information to Improve Energy Conservation Self-Efficacy in Parkinson's Disease

RecruitingNAAges 18 Years - anyAllUniversita degli Studi di Genova
NCT07094269 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This protocol describes a randomized, controlled, parallel-group, trial evaluating the effectiveness of a group-based fatigue management program for people with Parkinson's disease. The study will be conducted in Italy, with participant recruitment planned to begin on July 1st, 2025. The primary sponsor is the Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal Child Health (DINOGMI) at the University of Genoa, Italy. No external sources of monetary or material support have been declared. The study has received ethical approval from the University of Genoa's Research Ethics Committee (Comitato Etico per la Ricerca di Ateneo - CERA), under protocol number 2025.36, approved on April 3rd, 2025. The scientific title of the trial is: Protocol for a Superiority Randomized Controlled Trial of a Group-Based Fatigue Management Program Versus Standard Information to I

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📋 Eligibility rules (as published)
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
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What it tests

  • Occupational Therapy Intervention
  • Fact-sheets
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Where

1 site
Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal Child Health (DINOGMI) University of Genoa Genoa, Italy
Genova, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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