StrokeNCT07498114
Association Between Fatigue Severity and Health-Related Quality of Life in Individuals With Stroke
An observational study of Stroke and Quality of Life, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
This observational cross-sectional study aims to examine the association between fatigue severity and health-related quality of life in individuals with stroke. Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), and quality of life will be evaluated using the Nottingham Health Profile (NHP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Quality of Life, Post Stroke Fatigue
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2026to 25 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: unit/community stroke follow-up].
Inclusion Criteria:• Clinical diagnosis of stroke (ischemic or hemorrhagic)
- Time since stroke: ≥ [3] months
- Able to understand and complete questionnaires (with/without assistance)
- Provides informed consent
Exclusion Criteria:Severe cognitive impairment preventing valid questionnaire completion Severe aphasia preventing communication (if no reliable assistance) Unstable medical condition or acute complications Major neurological disease other than stroke (e.g., Parkinson's, MS)
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fatigue Severity Independently Predicts Health-Related Quality of Life in Stroke Survivors: A Cross-Sectional Study
This observational cross-sectional study aims to examine the association between fatigue severity and health-related quality of life in individuals with stroke. Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), and quality of life will be evaluated using the Nottingham Health Profile (NHP). The primary analysis will investigate the relationship between FSS total score and NHP total score and domain scores.
Read the detailed description
Participants with a diagnosis of stroke will be recruited from Istanbul Hospital. After obtaining informed consent, demographic and clinical characteristics will be recorded. Fatigue severity will be measured using the Fatigue Severity Scale (FSS). Health-related quality of life will be assessed using the Nottingham Health Profile (NHP), including its subdomains (e.g., energy level, pain, physical mobility, emotional reactions, sleep, social isolation). The primary objective is to determine the strength and direction of the association between fatigue and quality of life. Correlation analyses (e.g., Spearman/Pearson based on distribution) will be conducted, and exploratory multivariable models may be used to adjust for potential confounders (e.g., age, sex, time since stroke, stroke type, functional status).
- Conditions
- Stroke, Quality of Life, Post Stroke Fatigue
- 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 |
|---|---|---|
| Individuals with stroke meeting eligibility criteria. | No interventions will be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale
Fatigue Severity Scale (FSS) is a 9-item self-report questionnaire used to assess the severity of fatigue and its impact on daily functioning. Each item is scored on a 7-point Likert scale (1-7), with higher scores indicating greater fatigue severity. The FSS is a reliable and widely used measure in clinical and research settings.
Measured: Single assessment at enrollment (baseline)
Nottingham Health Profile
Nottingham Health Profile (NHP) is a self-reported questionnaire used to assess perceived health status and quality of life. It consists of 38 items covering six domains: physical mobility, pain, sleep, energy, social isolation, and emotional reactions. Higher scores indicate poorer health status.
Measured: Single assessment at enrollment (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start5 Mar 2026
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, osman coban, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498114
- Sponsor's protocol ID
- uskudarunivstroke
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ponchel A, Bombois S, Bordet R, Henon H. Factors Associated with Poststroke Fatigue: A Systematic Review. Stroke Res Treat. 2015;2015:347920. doi: 10.1155/2015/347920. Epub 2015 May 25.
PubMed 26101691Tang WK, Lu JY, Chen YK, Mok VC, Ungvari GS, Wong KS. Is fatigue associated with short-term health-related quality of life in stroke? Arch Phys Med Rehabil. 2010 Oct;91(10):1511-5. doi: 10.1016/j.apmr.2010.06.026.
PubMed 20875507
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue Severity Independently Predicts Health-Related Quality of Life in Stroke Survivors: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07498114
- Acronym / sponsor ID
- uskudarunivstroke
- Conditions
- Stroke, Quality of Life, Post Stroke Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 27 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.
This observational cross-sectional study aims to examine the association between fatigue severity and health-related quality of life in individuals with stroke. Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), and quality of life will be evaluated using the Nottingham Health Profile (NHP). The primary analysis will investigate the relationship between FSS total score and NHP total score and domain scores.
Detailed description
Participants with a diagnosis of stroke will be recruited from Istanbul Hospital. After obtaining informed consent, demographic and clinical characteristics will be recorded. Fatigue severity will be measured using the Fatigue Severity Scale (FSS). Health-related quality of life will be assessed using the Nottingham Health Profile (NHP), including its subdomains (e.g., energy level, pain, physical mobility, emotional reactions, sleep, social isolation). The primary objective is to determine the strength and direction of the association between fatigue and quality of life. Correlation analyses (e.g., Spearman/Pearson based on distribution) will be conducted, and exploratory multivariable models may be used to adjust for potential confounders (e.g., age, sex, time since stroke, stroke type, functional status).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with stroke meeting eligibility criteria. | – | –No interventions will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- unit/community stroke follow-up].
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
Time frame: Single assessment at enrollment (baseline)
Fatigue Severity Scale (FSS) is a 9-item self-report questionnaire used to assess the severity of fatigue and its impact on daily functioning. Each item is scored on a 7-point Likert scale (1-7), with higher scores indicating greater fatigue severity. The FSS is a reliable and widely used measure in clinical and research settings.
Nottingham Health Profile
Time frame: Single assessment at enrollment (baseline)
Nottingham Health Profile (NHP) is a self-reported questionnaire used to assess perceived health status and quality of life. It consists of 38 items covering six domains: physical mobility, pain, sleep, energy, social isolation, and emotional reactions. Higher scores indicate poorer health status.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Results publication: PubMed 26101691Ponchel A, Bombois S, Bordet R, Henon H. Factors Associated with Poststroke Fatigue: A Systematic Review. Stroke Res Treat. 2015;2015:347920. doi: 10.1155/2015/347920. Epub 2015 May 25.
- Results publication: PubMed 20875507Tang WK, Lu JY, Chen YK, Mok VC, Ungvari GS, Wong KS. Is fatigue associated with short-term health-related quality of life in stroke? Arch Phys Med Rehabil. 2010 Oct;91(10):1511-5. doi: 10.1016/j.apmr.2010.06.026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Stroke and Quality of Life, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 30 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: Single assessment at enrollment (baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07498114, which also lists 2 linked publications.
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 30 Mar 2026.