Post-Stroke Fatigue Perception Study (ReFast)
ConditionPost-stroke Fatigue
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSchool of Health Sciences Geneva
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Living in French-speaking Switzerland
Confirmed history of ischemic or hemorrhagic stroke
Self-reported fatigue attributed to stroke
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: Adults With Chronic Stroke and Post-Stroke Fatigue
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessed once at enrollment (single study visit, Day 0)2
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.
Time frame
Assessed once at enrollment (single study visit, Day 0)3
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.
Time frame
Assessed once at enrollment (single study visit, Day 0)4
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.
Time frame
Assessed once at enrollment (single study visit, Day 0)Secondary outcomes
1
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.
Time frame
Assessed once at enrollment (single study visit, Day 0)2
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.
Time frame
Assessed once at enrollment (single study visit, Day 0)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
School of Health Sciences Geneva
Lead sponsor
University Hospital, Geneva
Collaborator
Source ClinicalTrials.gov