Post-Stroke Fatigue Perception Study (ReFast)

NCT07444151 | Recruiting

• 1 other identifier: 2025-02382
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-stroke Fatigue

Keywords

Post-Stroke Fatigue; Quality of Life; Coping Strategies; Questionnaire Study; Neurological Rehabilitation; Stroke

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Qualitative Description of Subjective Fatigue Experience

  Assessed once at enrollment (single study visit, Day 0)

• Sociodemographic and Clinical Contextual Variables

  Assessed once at enrollment (single study visit, Day 0)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• School of Health Sciences Geneva: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

Haute école de santé de Genève (HEdS - HES-SO)

Carouge, Canton of Geneva, 1227, Switzerland

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pierre Nicolo, PhD

  HEdS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Nicolo, PhD

CONTACT

+41079263543; pierre.nicolo@hesge.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: March 2, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)