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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Post Stroke Fatigue Quality of Life Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Üsküdar Üniversitesi

Istanbul, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Mar 27, 2026
Registry last updated: Mar 30, 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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Completed