Post-Stroke Fatigue Perception Study (ReFast) (ReFast)

Exploration of Subjective Post-Stroke Fatigue: A Mixed-Methods Questionnaire Study (ReFast - Recovery and Fatigue Study)

The goal of this observational study is to better understand fatigue after stroke. Many people feel ongoing tiredness months or years after a stroke. This fatigue may affect daily activities, work, and social life. It does not always improve with rest.

This study aims to answer these questions:

How do participants describe their fatigue?

How strong and how often does it occur?

How does it affect daily life and quality of life?

What strategies do participants use to manage it?

About 20 to 30 adults living in French-speaking Switzerland who have had a stroke will take part.

Participants will:

Complete one anonymous questionnaire online or on paper.

Answer questions about their fatigue and daily life.

Share their experience in their own words.

The questionnaire takes about 15 to 20 minutes. There are no medical tests, treatments, or follow-up visits.

Participation is voluntary. Participants may stop at any time. No names or identifying information are collected.

The results may help health professionals better understand post-stroke fatigue and improve rehabilitation care.

Study Overview

• Status: Recruiting
• Conditions: Post-stroke Fatigue

Detailed Description

Post-stroke fatigue is a common and long-lasting symptom experienced by many people after a stroke. It is described as persistent physical, cognitive, or emotional exhaustion that is not proportional to effort and does not consistently improve with rest. Although fatigue can strongly affect participation, autonomy, and quality of life, it remains insufficiently understood and often under-recognized in rehabilitation practice.

The ReFast study (Recovery and Fatigue Study) is a non-interventional, cross-sectional observational study conducted in French-speaking Switzerland. The aim is to explore the subjective experience of post-stroke fatigue in adults living at home in the chronic phase after stroke. The study focuses on understanding how participants perceive their fatigue, how it affects daily life, and which coping strategies they use.

Data will be collected through a single anonymous questionnaire that combines structured questions (including rating scales and multiple-choice items) with open-ended questions. This mixed-methods approach allows both quantitative description and qualitative exploration of participants' experiences.

Primary outcomes relate to the presence, intensity, frequency, and functional impact of fatigue. Secondary outcomes include perceived quality of life, coping strategies, perceived social or professional support, and contextual factors such as age and time since stroke. Open-ended responses will be analyzed using inductive thematic analysis to identify recurring themes and patterns.

The study does not involve any medical intervention, clinical examination, or follow-up visit. Participation consists of completing one questionnaire session. All data are collected anonymously, and no identifying information is recorded. The overall risk is minimal and limited to possible mild emotional discomfort when reflecting on personal experiences.

By integrating quantitative and qualitative perspectives, this study seeks to generate clinically relevant insights into post-stroke fatigue. The findings may support the development of more patient-centered rehabilitation approaches and inform future research in neurological rehabilitation.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Pierre Nicolo, PhD; Phone Number: +41 22 558 64 +41079263543; Email: pierre.nicolo@hesge.ch

Study Locations

• Switzerland
  • Canton of Geneva
    • Carouge, Canton of Geneva, Switzerland, 1227
      • Recruiting
      • Haute école de santé de Genève (HEdS - HES-SO)
      • Contact: Pierre Nicolo, PhD; Phone Number: +41 22 558 64 51; Email: pierre.nicolo@hesge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adults aged 18 years or older living in French-speaking Switzerland who have experienced an ischemic or hemorrhagic stroke and report persistent fatigue in the chronic phase. Participants live in the community and are able to read and understand written French. The study focuses on individuals who self-identify fatigue as a consequence of stroke and who are able to independently complete an anonymous questionnaire about their experience.

Description

Inclusion Criteria:

• Age 18 years or older
• Living in French-speaking Switzerland
• Confirmed history of ischemic or hemorrhagic stroke
• Self-reported fatigue attributed to stroke
• Living in the community (not institutionalized)
• Able to read and understand written French
• Able to provide informed consent

Exclusion Criteria:

• Transient ischemic attack (TIA) without confirmed stroke
• History of two or more strokes
• Currently institutionalized (e.g., nursing home, long-term hospital care, rehabilitation center)
• Fatigue primarily caused by another chronic medical condition (e.g., cancer, primary depression, multiple sclerosis)
• Severe cognitive or communication impairment preventing independent completion of the questionnaire
• Unable to understand written French

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Adults With Chronic Stroke and Post-Stroke Fatigue; Adults aged 18 years or older living in French-speaking Switzerland who have experienced a stroke and report persistent fatigue in the chronic phase (six months or more after stroke). Participants live in the community and complete one anonymous questionnaire about their experience of fatigue, its impact on daily life, and coping strategies. No medical intervention or follow-up is involved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Severity Scale (FSS) Total Score	Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), a validated 9-item questionnaire measuring subjective fatigue and its functional impact. Each item is rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score is calculated as the mean of the 9 items and ranges from 1 to 7. Higher scores indicate greater fatigue severity.	Assessed once at enrollment (single study visit, Day 0)
Presence of Self-Reported Post-Stroke Fatigue	Presence of post-stroke fatigue will be assessed using a study-specific Post-Stroke Fatigue Questionnaire developed for this cross-sectional study. Participants respond "Yes" or "No" to a binary item assessing whether they have experienced unusual fatigue since their stroke. This is a categorical variable (Yes/No). The proportion of participants reporting "Yes" will be calculated. Higher frequency of "Yes" responses indicates greater prevalence of self-reported post-stroke fatigue.	Assessed once at enrollment (single study visit, Day 0)
Self-Reported Fatigue Intensity	Fatigue intensity will be assessed using the study-specific Post-Stroke Fatigue Questionnaire. The Fatigue Intensity Score is calculated as the mean of multiple items rated on a 5-point Likert scale ranging from 1 (low fatigue) to 5 (very high fatigue). The score ranges from 1 to 5. Higher scores indicate greater perceived fatigue intensity.	Assessed once at enrollment (single study visit, Day 0)
Self-Reported Functional Impact of Fatigue on Daily Activities	Functional impact of fatigue on daily activities (e.g., household tasks, work, leisure, rehabilitation) will be assessed using multiple structured items from the study-specific questionnaire. Each item is rated on a 5-point Likert scale ranging from 1 (no impact) to 5 (very high impact). The Functional Impact Score is calculated as the mean of these items and ranges from 1 to 5. Higher scores indicate greater functional limitation related to fatigue.	Assessed once at enrollment (single study visit, Day 0)
Self-Reported Frequency of Post-Stroke Fatigue	Frequency of fatigue will be assessed using a structured categorical item in the study-specific questionnaire with predefined response options (e.g., daily, several times per week, occasionally, rarely). This is an ordinal categorical variable. Higher frequency categories reflect more frequent fatigue episodes.	Assessed once at enrollment (single study visit, Day 0)
Self-Reported Quality of Life Related to Fatigue	Quality of life related to fatigue will be assessed using multiple Likert-scale items from the study-specific questionnaire. Each item is rated from 1 (very poor quality of life) to 5 (very good quality of life). The Quality of Life Score is calculated as the mean of these items, ranging from 1 to 5. Higher scores indicate better perceived quality of life.	Assessed once at enrollment (single study visit, Day 0)
Self-Reported Coping Strategies for Managing Fatigue	Coping strategies used to manage fatigue (e.g., rest breaks, activity planning, physical activity) will be assessed using predefined multiple-choice items and optional open-ended responses in the study-specific questionnaire. Results will be summarized descriptively as counts and percentages.	Assessed once at enrollment (single study visit, Day 0)
Perceived Social and Professional Support	Perceived social and professional support will be assessed using multiple Likert-scale items from the study-specific questionnaire. Each item is rated on a 5-point Likert scale ranging from 1 (no perceived support) to 5 (very strong perceived support). The Support Score is calculated as the mean of these items, ranging from 1 to 5. Higher scores indicate greater perceived support.	Assessed once at enrollment (single study visit, Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative Description of Subjective Fatigue Experience	Open-ended responses describing the subjective experience of fatigue, including emotional, cognitive, and functional aspects, will be collected. Responses will undergo inductive thematic analysis.	Assessed once at enrollment (single study visit, Day 0)
Sociodemographic and Clinical Contextual Variables	Sociodemographic and clinical characteristics including age, sex, time since stroke, employment status, level of autonomy, and comorbidities will be collected for descriptive and stratification purposes. These are descriptive variables.	Assessed once at enrollment (single study visit, Day 0)

Collaborators and Investigators

• Sponsor: School of Health Sciences Geneva
• Collaborators: University Hospital, Geneva
• Investigators: Principal Investigator: Pierre Nicolo, PhD, HEdS

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Quality of Life; Neurological Rehabilitation; Coping Strategies; Post-Stroke Fatigue; Questionnaire Study
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 2025-02382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because all data are collected anonymously and without any direct or indirect identifiers. The dataset is limited to a small exploratory sample collected within the framework of an academic Bachelor project. In accordance with the study protocol and institutional policies, the data are intended solely for the objectives described in the approved research project. Any future reuse of the data would require a new ethics application and approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No