Post-stroke FatigueReFastNCT07444151
Post-Stroke Fatigue Perception Study (ReFast)
An observational study of Post-stroke Fatigue, run by School of Health Sciences Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Fatigue
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Jan 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Haute école de santé de Genève (HEdS - HES-SO)
Carouge, Canton of Geneva, 1227
Pierre Nicolo, PhD, +41 22 558 64 51, pierre.nicolo@hesge.ch
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Post-stroke Fatigue
- Keywords
- Post-Stroke Fatigue, Quality of Life, Coping Strategies, Questionnaire Study, Neurological Rehabilitation, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed once at enrollment (single study visit, Day 0)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Assessed once at enrollment (single study visit, Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start27 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- School of Health Sciences Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Principal investigator, Pierre Nicolo, PhD, School of Health Sciences Geneva
- Investigators
- Pierre Nicolo, PhD, Principal investigator, HEdS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444151
- Sponsor's protocol ID
- 2025-02382
- Other IDs
- 2025
- Acronym
- ReFast
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Subjective Post-Stroke Fatigue: A Mixed-Methods Questionnaire Study (ReFast - Recovery and Fatigue Study)
- ClinicalTrials.gov ID
- NCT07444151
- Acronym / sponsor ID
- ReFast / 2025-02382
- Conditions
- Post-stroke Fatigue
- Keywords
- Post-Stroke Fatigue, Quality of Life, Coping Strategies, Questionnaire Study, Neurological Rehabilitation, Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- School of Health Sciences GenevaUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Qualitative Description of Subjective Fatigue Experience
Time frame: Assessed once at enrollment (single study visit, Day 0)
Sociodemographic and Clinical Contextual Variables
Time frame: Assessed once at enrollment (single study visit, Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Post-stroke Fatigue
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Effect of a Multidimensional Intervention Programme on Post-stroke Fatigue
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Brain Stimulation Effects on Post-Stroke Fatigue and Aphasia
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Transcranial Direct Current Stimulation and Cognitive Behavioural Programme on Post-stroke Fatigue
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Repetitive Transcranial Magnetic Stimulation, a Form of Non-invasive Brain Stimulation, as a Possible Treatment for Post-stroke Fatigue
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre Nicolo, PhD principal investigator
HEdS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-stroke Fatigue, run by School of Health Sciences Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Nicolo, PhD (+41079263543 ext. +41 22 558 64, pierre.nicolo@hesge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (FSS) Total Score (time frame: Assessed once at enrollment (single study visit, Day 0)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.