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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)
研究概览
简要总结
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: 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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Due to the nature of the intervention, neither participants nor care providers will be masked to treatment allocation. However, data analysts and outcome assessors responsible for evaluating clinician-reported outcomes will be masked to group assignment to reduce the risk of assessment bias. To ensure assessor blinding, the individuals performing clinical outcome evaluations were not involved in participant enrollment or intervention delivery and were not informed of the assigned treatment groups. Participants and staff were instructed not to disclose allocation information during assessments. No blinding procedures were applied to the appearance or labeling of interventions, as blinding was not feasible for other roles
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged >18 years
- •diagnosis of idiopathic Parkinson's disease (PD)
- •Hoehn and Yahr stage ≤3.5
- •Fatigue Severity Scale (FSS) >= 4
排除标准
- •Montreal Cognitive Assessment (MoCA) score <22
- •comorbid medical conditions that could independently contribute to fatigue
- •not being fluent in the Italian language
- •Parkinsonism
研究组 & 干预措施
Packer Managing Fatigue Program
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) 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. A structured intervention manual and session-specific checklists will guide therapist and ensure intervention fidelity.
干预措施: Occupational Therapy Intervention (Other)
Fact sheets about Parkinson's disease
Participants in the control group will be provided with six fact sheets (one per week) addressing general information about Parkinson's disease,. The control group reflects current standard care, as no structured fatigue intervention is routinely provided in this clinical setting.
干预措施: Fact-sheets (Behavioral)
结局指标
主要结局
Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)
时间窗: Baseline, End of Treatment (7 week) and at 3 months
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.
次要结局
- Fatigue Severity Scale (FSS)(Baseline, End of Treatment (7 week) and at 3 months)
- Parkinson Fatigue Scale (PFS)(Baselibe, End of Treatment /7 weeks) and 3 months)
- Modified Fatigue Impact Scale (MFIS)(Baseline, End of Treatment /7 weeks), 3 months)
- Parkinson's Disease Questionnaire-39 (PDQ-39)(Baseline, End of Treatment (7 weeks), at 3 months)
- Impact on Participation and Autonomy (IPA)(Baseline, end of treatment /7 weeks), at 3 months)
- Community Integration Questionnaire-Revised (CIQ-R)(Baseline, End of Treatment (7 weeks), at three months)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, end of treatment /7 weeks), three months)
- Hospital Anxiety and Depression Scale (HADS)(Baseline, end of treatment (7 weeks), at 3 months)
- Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I and II(Baseline, end of Treatment (7 weeks), at 3 months)
- Occupational Balance Questionnaire (OBQ-11)(Baseline, end of treatment /7 weeks), at 3 months)
- Fatigue Severity Scale (FSS)(Baseline, End of Treatment (7 week) and at 3 months)
- Parkinson Fatigue Scale (PFS)(Baselibe, End of Treatment /7 weeks) and 3 months)
- Modified Fatigue Impact Scale (MFIS)(Baseline, End of Treatment /7 weeks), 3 months)
- Parkinson's Disease Questionnaire-39 (PDQ-39)(Baseline, End of Treatment (7 weeks), at 3 months)
- Impact on Participation and Autonomy (IPA)(Baseline, end of treatment /7 weeks), at 3 months)
- Community Integration Questionnaire-Revised (CIQ-R)(Baseline, End of Treatment (7 weeks), at three months)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, end of treatment /7 weeks), three months)
- Hospital Anxiety and Depression Scale (HADS)(Baseline, end of treatment (7 weeks), at 3 months)
- Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I and II(Baseline, end of Treatment (7 weeks), at 3 months)
研究者
Elisa Pelosin
Prof.
Universita degli Studi di Genova