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 22, 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 and fatigue.
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), occupational balance (Occupational Balance Questionnaire-11) 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: [email protected]). For scientific queries, the reference contact is the University of Genoa's Ethics Committee (email: [email protected]).
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
aged >18 years
diagnosis of idiopathic Parkinson's disease (PD)
Hoehn and Yahr stage ≤3.5
Fatigue Severity Scale (FSS) >= 4
Montreal Cognitive Assessment (MoCA) score <22
comorbid medical conditions that could independently contribute to fatigue
not being fluent in the Italian language
Parkinsonism
Parallel
Occupational Therapy Intervention
Other interventionParticipants in the intervention group will take part in the structured, manualized Packer Managing Fatigue Group Program (Packer et al.), delivered in groups of 8-10 by a licensed occupational therapist. The intervention will consist of six weekly sessions, each lasting 120 minutes, held in a dedicated outpatient room equipped with a whiteboard, group seating, and educational materials. Each session will address a specific theme: (1) The importance of Rest, (2) Communication and Body Mechanics, (3) Tools, Technology, and ergonomics, (4) Priorities and Standard (5) Putting it all Together, (6) Some Closing Thoughts. Materials will include a participant workbook2, printed handouts, pens, markers, and name tags. All materials will be provided in Italian.
Fact-sheets
BehavioralParticipants in the control group will receive six weekly fact sheets containing general information about Parkinson's disease. These fact sheets serve as a placebo intervention to control for attention and information exposure, without providing any structured fatigue management strategies. This approach helps isolate the specific effects of the active intervention compared to usual care.
Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)
The SEPECSA was originally developed by Liepold and Mathiowetz's (2005) confidence in applying energy conservation strategies among individuals with MS. It consists of 14 items listing energy-saving strategies, with each item scored on a 10-point Likert-type scale (1 = "I never do it," 10 = "I always do it"). The assessment took approximately 10-15 minutes to complete. The final score was found by adding the total items' score and dividing it by 14. Psychometric properties of the original SEPECSA include high internal consistency (Cronbach's alpha = 0.93) and acceptable construct validity, as demonstrated by its correlation with fatigue levels and quality-of-life measures. This instrument measures individuals' confidence in implementing specific fatigue management techniques in daily life.
Fatigue Severity Scale (FSS)
Fatigue severity scale (FSS) is one of the most commonly used tools to measure fatigue. It was developed by Krupp et al. for patients with systemic lupus erythematosus and multiple sclerosis. However, it was later validated for various conditions such as obesity, chronic hepatitis C, cirrhosis, Parkinson's disease, postpartum, stroke, and post-polio. It was also validated into several languages such as Norwegian, Turkish, Swiss,German, English, Portuguese, Greek,Persian, Arabic, Italian, Chinese, Finnish,and Russian. The FSS is a 9-item self-reported scale. Each item is rated on a 7-point Likert scale from 1 = "strongly disagree" to 7 = "strongly agree". The total score is the unweighted mean of all items.
Parkinson Fatigue Scale (PFS)
The Parkinson Fatigue Scale (PFS) contains 16 questions: 7 questions related to tiredness and the effect of physical fatigue and 9 questions that evaluate the effect of fatigue on performance and daily activities. As mentioned, the questionnaire was completed by the subjects, and the score for each question ranged from 1 (definitely disagree) to 5 (definitely agree)
Modified Fatigue Impact Scale (MFIS)
The MFIS questionnaire is the modified form of the 40-item Fatigue Impact Scale (FIS) that has three dimensions and 21 questions (Fisk et al., 1994a). The total MFIS score is composed of nine items for physical status, 10 items for cognitive status, and two items for psychosocial function status.
Parkinson's Disease Questionnaire-39 (PDQ-39)
The PDQ-39 comprises 39 questions with five different options of answer related to the frequency of the disease manifestation. Answers refer to impact of the illness on the PD patient's life in the previous month, as explained before the interview. The 39 questions are divided into 8 dimensions: mobility (1-10 questions), activities of daily living (ADL) (11-16 questions), emotional wellbeing (17-22 questions), stigma (23-26 questions), social support (27-29 questions), cognition (30-33 questions), communication (34-36 questions), and bodily discomfort(37-39 questions). The score for each question ranges from zero (0) to four (4): "never" = 0; "occasionally" = 1; "sometimes" = 2; "often" = 3; "always" = 4. The final score is the result of the following equation: the sum of each question score divided by the result times 4 (the maximal score for each question), divided by the total number of questions. This result is multiplied times by 100. Each dimension score ranges from 0 to 100.
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