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

Fatigue Severity Independently Predicts Health-Related Quality of Life in Stroke Survivors: A Cross-Sectional Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07498114
Enrollment
53
Registered
2026-03-27
Start date
2026-03-05
Completion date
2026-03-25
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Stroke Fatigue, Quality of Life, Stroke

Brief 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.

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).

Interventions

None listed

Sponsors

Uskudar University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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) \-

Design outcomes

Primary

MeasureTime frameDescription
Fatigue Severity ScaleSingle 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 ProfileSingle 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026