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

March 26, 2026 updated by: osman coban, Uskudar University

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

unit/community stroke follow-up].

Description

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)

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Individuals with stroke meeting eligibility criteria.
No interventions will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Single assessment at enrollment (baseline)
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.
Single assessment at enrollment (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uskudar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2026

Primary Completion (Actual)

March 25, 2026

Study Completion (Actual)

March 25, 2026

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • uskudarunivstroke

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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