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NCT Number: NCT07444151

Post-Stroke Fatigue Perception Study (ReFast)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Carouge, Canton of Geneva, 1227, Switzerland

Location status: Recruiting

Location contact

Pierre Nicolo, PhD

CONTACT

[email protected]

+41 22 558 64 51

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fatigue Severity Scale (FSS) Total Score

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

    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.

  2. Presence of Self-Reported Post-Stroke Fatigue

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

    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.

  3. Self-Reported Fatigue Intensity

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

    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.

  4. Self-Reported Functional Impact of Fatigue on Daily Activities

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

    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.

  5. Self-Reported Frequency of Post-Stroke Fatigue

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

    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.

  6. Self-Reported Quality of Life Related to Fatigue

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

    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.

  7. Self-Reported Coping Strategies for Managing Fatigue

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

    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.

  8. Perceived Social and Professional Support

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

    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.

Secondary outcomes

  1. Qualitative Description of Subjective Fatigue Experience

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

    Open-ended responses describing the subjective experience of fatigue, including emotional, cognitive, and functional aspects, will be collected.

    Responses will undergo inductive thematic analysis.

  2. Sociodemographic and Clinical Contextual Variables

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre Nicolo, PhD

CONTACT

[email protected]

+41079263543 ext. +41 22 558 64

Sponsors and collaborators

Lead sponsor

School of Health Sciences Geneva

Other

Collaborators

  • University Hospital, Geneva

Registry information

Official study title

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

Acronym: ReFast

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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