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

Introduction

Fatigue is one of the most prevalent and disabling non-motor symptoms in Parkinson's disease (PD), affecting approximately 50% of individuals and significantly impairing occupational performance, participation in daily life, and overall quality of life. According to the systematic review and meta-analysis by Siciliano et al. (2018), fatigue in PD represents a frequent and distinct clinical feature that is not attributable to pharmacological side effects or comorbid psychiatric disorders. It can emerge in the early stages of the disease and tends to persist or worsen over time. As described by Friedman (2015), PD-related fatigue is characterized by a subjective sense of exhaustion and reduced energy, disproportionate to effort, unrelieved by rest, and affecting both physical and cognitive functioning. Its multidimensional and persistent nature makes it particularly difficult to treat.

Despite its considerable impact, no pharmacological treatments have demonstrated consistent efficacy for fatigue in PD. As a result, growing attention has been directed toward non-pharmacological approaches, particularly those delivered by occupational therapists. Occupational therapy interventions often focus on fatigue self-management and energy conservation strategies, aiming to support individuals in maintaining engagement in meaningful activities and improving daily functioning.

In this context, the Packer Managing Fatigue Group Program (MFGP) represents a structured, evidence-based occupational therapy intervention that has demonstrated effectiveness in populations with multiple sclerosis and post-polio syndrome. As highlighted in the systematic review by Kim et al. (2021), seven out of ten energy conservation studies were based on the MFGP, confirming it as one of the most evidence-supported interventions in the field. No adverse effects have been reported in previous studies evaluating the MFGP in other neurological populations.

Nonetheless, evidence supporting the use of the MFGPMFGP in individuals with PD remains extremely limited. To date, only one randomized controlled trial has been planned in this population. The protocol published by Alizadeh et al. (2022) describes the implementation of an individual, telehealth-based version of the program. While this study confirms the feasibility of a one-to-one delivery model, it does not examine the original group-based format, which has been shown to be cost-effective, socially engaging, and scalable in other clinical populations. Furthermore, participants in that study were drawn from heterogeneous diagnostic groups, and outcomes specific to individuals with PD were not reported separately.

Implementing the program in a group setting may enhance its therapeutic value by promoting peer support, shared learning experiences, and a sense of mutual accountability-factors that are known to facilitate sustained engagement in self-management behaviors.

Given the current lack of established treatment protocols for fatigue in Parkinson's disease, and the absence of evidence supporting even the individual delivery of the MFGP in this population, a comparator reflecting usual care was deemed most appropriate. At present, individuals with PD do not routinely receive targeted interventions for fatigue within standard clinical practice. Therefore, the control group in this study will receive a set of educational brochures specifically developed to provide structured, evidence-informed information about fatigue and energy conservation strategies. This approach ensures that all participants have access to relevant health information while allowing the study to assess the added value of structured, therapist-led group intervention over passive information provision.

Given the high prevalence of fatigue in PD, the lack of effective treatments, and the limited availability of standardized occupational therapy programs addressing this issue in Italy, there is a compelling need for further investigation. The objective of this trial is to evaluate the efficacy of the Packer Managing Fatigue Group Program, , in improving self-efficacy for energy conservation strategies in individuals with Parkinson's disease. Participants in the control group will be provided with six fact sheets addressing general information about Parkinson's disease. The primary outcome is self-efficacy, measured using the Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA), with assessments conducted at baseline, immediately post-intervention, and at 3-month follow-up. This randomized controlled trial aims to determine whether the structured group program leads to superior outcomes compared to passive information delivery. This study addresses an unmet rehabilitative need and has the potential to inform future clinical guidelines for managing fatigue in PD through occupational therapy.

Methods

Patient and public involvement

Patients or members of the public were not involved in the initial design or development of this trial. The research questions, outcome measures, and intervention content were established based on clinical expertise, existing research evidence, and international best practices in occupational therapy for fatigue management. Nevertheless, the study team recognizes the value of incorporating patient perspectives and plans to engage participants during later stages of the research. Specifically, participants will be invited to: provide qualitative feedback on the acceptability and clarity of the intervention materials following the program, and contribute to the creation of a plain language summary of the trial results, ensuring it is accessible and meaningful for people living with Parkinson's disease.

Trial Design

This will be a two-arm controlled trial adopting a superiority framework. Participants were will be allocated to either the intervention group or the control group using a stratified block allocation approach with a 1:1 ratio.

Trial Setting

The trial will be conducted at a single site in Genoa, Italy, within the outpatient setting of the Neurology Clinic at the Department of Clinical and Experimental Neurosciences (DINOGMI), University of Genoa. The clinic is located near the main university hospital and functions as a tertiary care ambulatory center for individuals with neurological disorders. All participant recruitment, intervention delivery, and follow-up assessments will be conducted within this outpatient facility.

Eligibility Criteria

Participants were will be eligible for inclusion if they were are adults (aged \>18 years) with a diagnosis of idiopathic PD, Hoehn and Yahr stage ≤3.5, a score ≥4 on the Fatigue Severity Scale (FSS), and a Montreal Cognitive Assessment (MoCA) score \>22. Exclusion criteria included the presence of significant cognitive impairment, comorbid medical conditions that could independently contribute to fatigue, parkinsonism, non parlare fluentemente la lingua italianaor not being fluent in the Italian language, or an inability to participate in group-based sessions. Recruitment will be conducted through both neurologist referral and self-selection. In the referral pathway, clinicians will recommended participation during routine outpatient consultations at the Neurology Clinic Recruitment will occur through both neurologist referral and self-selection. In the referral pathway, neurologists will provide eligible patients with written information about the study during routine outpatient visits. Patients who express interest will be invited to contact the research team independently. Additionally, informational brochures will be distributed in Parkinson's associations and community clinics to support self-referral. For self-selection, informational brochures describing the study were will be distributed in Parkinson's clinics and centres across the region, including through the Ligure Parkinson Association For self-selection, informational brochures describing the study werewill be distributed at the Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal Child Health. Copies of recruitment materials are provided in the Supplementary Materials. As the trial will be conducted at a single site, no specific eligibility criteria for site selection were applied beyond the availability of suitable facilities for group-based interventions and follow-up assessments.

The intervention will be delivered by a licensed occupational therapist with clinical experience in neurological rehabilitation and be trained and licensed to deliver formal training in the Packer Managing Fatigue Group Program (MFGP) protocol. Prior to the trial, the therapist will completeed a standardized training and a familiarization process to ensure fidelity to the original intervention model.

Methods

Patient and public involvement, trial design

Patients wereill be actively involved at all stages of the trial, including its design, conduct, and dissemination, in accordance with established recommendations. During the initial design phase, approximately twenty individuals with Parkinson's disease were consulted to assess the perceived usefulness of a similar self-management fatigue group and to explore their expectations regarding meaningful improvements; this qualitative inquiry informed the identification of relevant outcomes. Throughout the intervention in the qualitative study, verbal feedback wasill be solicited from participants during each session and at the post-treatment assessment; all responses wereill be audio-recorded and fully transcribed by the researcher . Upon completion of the trial, a lay summary written in accessible language will be prepared and disseminated to all participants to communicate the study findings.

The randomisation approach, eligibility criteria, intervention procedures, outcome measures (including methods of assessment and timepoints), target sample size, number of trial arms, duration of follow-up, and statistical analysis plan remained consistent with the pre-specified protocol. No unplanned or post hoc outcomes were introduced, and no modifications to trial conduct (e.g., site exclusion or adjustment of procedures) were required throughout the study period.

Participants, interventions, and outcomes

Participants in the intervention group will take part in thea structured, manualized fatigue self-management program based on the Packer Managing Fatigue Group Program, 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) rest and sleepThe importance of Rest, (2) Communication and Body Mechanics, (3) energy-conserving tTools, Technology, and ergonomics, (4) Priorities and Standard (5) Putting it all Together, prioritization, (5) lifestyle balance, and (6) goal setting(6) Some Closing Thoughts. Materials will include a participantparticipant workbook, printed handouts, pens, markers, and name tags. All materials will be provided in Italian. A structured intervention manual and session-specific checklists will guide therapists and ensure intervention fidelity.

The program will follow a standardized format without individual tailoring, although participants will be allowed to contact the therapist between sessions for clarification. Missed sessions will be rescheduled individually when feasible. The program will follow a standardized format in terms of structure and content; however, participants will be encouraged to personalize their between-session activities and homework based on their individual goals and routines. While session content will not be tailored, participants may contact the therapist between sessions for clarification. If a session is missed, an individual make-up session will be schedul

• Fatigue Severity Scale (FSS) [Срок оценки: Baseline, End of Treatment (7 week) and at 3 months]
• Parkinson Fatigue Scale (PFS) [Срок оценки: Baselibe, End of Treatment /7 weeks) and 3 months]
• Modified Fatigue Impact Scale (MFIS) [Срок оценки: Baseline, End of Treatment /7 weeks), 3 months]
• Parkinson's Disease Questionnaire-39 (PDQ-39) [Срок оценки: Baseline, End of Treatment (7 weeks), at 3 months]
• Impact on Participation and Autonomy (IPA) [Срок оценки: Baseline, end of treatment /7 weeks), at 3 months]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline, end of treatment /7 weeks), three months]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline, end of treatment (7 weeks), at 3 months]
• Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I and II [Срок оценки: Baseline, end of Treatment (7 weeks), at 3 months]
• Occupational Balance Questionnaire (OBQ-11) [Срок оценки: Baseline, end of treatment /7 weeks), at 3 months]