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CompletedNCT07498114Updated Mar 30, 2026

Association Between Fatigue Severity and Health-Related Quality of Life in Individuals With Stroke

An observational study in Stroke, Quality of Life and Post Stroke Fatigue, sponsored by Uskudar University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Uskudar University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
53
Ages
18 Years and older
Sex
All
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Study 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). 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).

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Conditions studied

  • Stroke
  • Quality of Life
  • Post Stroke Fatigue

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 53 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Uskudar University is the lead sponsor of 164 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

unit/community stroke follow-up].

Eligibility criteria

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)

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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
53 participants (actual)
Patient registry
No

Groups and cohorts

  • Individuals with stroke meeting eligibility criteria.

    No interventions will be administered

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Single assessment at enrollment (baseline)

  2. 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.

    Time frame: Single assessment at enrollment (baseline)

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Study locations

1 site
  • Üsküdar Üniversitesi
    Istanbul, Turkey (Türkiye)
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References and documents

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 26101691 ↗
  • Tang 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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07498114
Lead sponsor
Uskudar University
Responsible party
osman coban (Asst. Prof., Uskudar University) — Principal investigator
First posted
Mar 27, 2026
Start date
Mar 5, 2026
Primary completion
Mar 25, 2026
Completion
Mar 25, 2026
Last update
Mar 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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