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 Improve Self-Efficacy in Energy Conservation in Parkinson's Disease". The public title is: "Energy Matters: A Protocol of a Randomized Controlled Trial of a Group-Based Fatigue Management Program for People with Parkinson's Disease". The study targets individuals diagnosed with idiopathic Parkinson's disease, experiencing fatigue. Eligible participants must be over 18 years old, present with Hoehn and Yahr stage ≤3.5, and score ≥4 on the Fatigue Severity Scale (FSS). Exclusion criteria include a Montreal Cognitive Assessment (MOCA) score below 21, presence of severe psychiatric comorbidities, medical conditions contributing independently to fatigue, inability to participate in group sessions, or involvement in other structured fatigue management programs. Participants will be randomly allocated to one of two arms. The intervention group will attend a six-week Packer Managing Fatigue Program1 Sessions will be conducted in groups of 8-10 participants, led by a licensed occupational therapist. Topics covered include rest, communication, body mechanics, ergonomics, energy-conserving tools, prioritization, lifestyle balance, and goal setting. Sessions will use standardized materials such as participant workbooks2 and visual aids and will take place in appropriately equipped rooms. If a participant is absent from a scheduled group session for personal reasons, the occupational therapist will organize an individual make-up session before the next scheduled group session. This individual session will follow the same content and structure as the missed group session, based on the Packer Managing Fatigue Program. Its purpose is to ensure continuity and fidelity to the intervention, and to allow participants to stay aligned with the group program. Participants in the control group will be provided with six fact sheets addressing general information about Parkinson's disease. The primary outcome is the change in self-efficacy for performing energy conservation strategies, measured using the Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA), assessed at baseline, post-intervention, and at a 3-month follow-up. Secondary outcomes include measures of motor and non-motor symptoms (Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I and II), fatigue severity (Fatigue Severity Scale, Parkinson Fatigue Scale), Fatigue Impact (Modified Fatigue Impact Scale), quality of life (Parkinson Disease Questionnaire-39), participation and autonomy (Impact on Participation and Autonomy questionnaire), psychiatric symptoms (Hospital Anxiety and Depression Scale), and sleep disturbance (Pittsburgh Sleep Quality Index - PSQI). All outcomes will be reassessed immediately and 3 months after the end of the intervention. The total planned sample size is 74 participants, with 37 individuals in each study arm. For public queries, the contact person is Dr. Elisa Pelosin, Associate Professor at DINOGMI, University of Genoa (email: elisa.pelosin@unige.it). For scientific queries, the reference contact is the University of Genoa's Ethics Committee (email: presidente.cera@unige.it). An individual participant data sharing plan is in place. As part of the informed consent process, participants will be asked whether they agree to allow their anonymized data to be shared for future research purposes. Only data from participants who provide explicit consent will be shared. Anonymized individual data will be made available upon reasonable request, in accordance with institutional policies and data protection regulations. Access will be granted by the corresponding author after publication and will remain open for five years
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)
Timeframe: Baseline, End of Treatment (7 week) and at 3 months