we Use Recovery Time to Assess Post-dialysis Fatigue and we Use Also Two Different Fatigue Scales 1- Visual Analogue Scale 2- Fatigue Severity Scale and we Address Risk Factors of PDF and Apply the Scales on Regular Hemodialysis Patients in Hemodialysis Unit of Assiut University Hospital

April 19, 2025 updated by: Christina Kamel Hanna Soliman, Assiut University

Factors Predicting and Assessment of Post Dialysis Fatigue in Patients on Regular Hemodialysis in Assiut University Hospital

To improve the quality of life of hemodialysis patients and provide better control for post dialysis fatigue in regular hemodialysis patients.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Post-dialysis fatigue (PDF) is a prevalent and debilitating symptom among patients undergoing regular hemodialysis, characterized by a persistent sense of physical and mental exhaustion following dialysis sessions This condition adversely affects patients' quality of life, daily functioning, and adherence to treatment regimens .Despite its high prevalence, PDF remains under-recognized and inadequately addressed in clinical practice. The etiology of PDF is multifactorial, encompassing physiological, psychological, and lifestyle-related factors. Recent studies have identified several predictors of PDF, including sleep disorders, the presence of comorbidities, the number of weekly dialysis sessions, and the duration of hemodialysis treatment . The symptoms and severity of PDF are evaluated using various scales. In cases of PDF, to examine the subjective symptoms of patients themselves, it is useful to utilize patient-based outcomes. However, in conventional PDF studies, the evaluation indices have not been uniform. First, in studies evaluating fatigue after dialysis based on the "time," "frequency," and "intensity" the reliability and validity of the scales were not examined. Second, the recovery time is not an index that measures PDF directly but instead an indirect indicator that measures the "time to recover from hemodialysis." Third, the fatigue scale does not measure true PDF but rather chronic fatigue experienced by dialysis patients .

in that research we use time recovery to assess post-dialysis fatigue and we use also two different fatigue scales visual analogue scale to evaluate fatigue severity and fatigue severity scale In that research we address risk factors of PDF and apply the scales on regular hemodialysis patients in hemodialysis unit of Assiut University Hospital.

Study Type

Observational

Enrollment (Estimated)

155

Contacts and Locations

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

Study Contact

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

adult patients on regular hemodialysis on hemodialysis unit of assiut university hospital

Description

Inclusion Criteria:

  • • End stage renal diseases (ESRD) patients who receive hemodialysis 3 times a week for 4 h each time.

    • > 20 years of age.
    • Both sexes.
    • Patients with stable clinical examination.
    • Patients who receiving hemodialysis for more than 3 months.
    • All patients were able to go to the center for hemodialysis on their own.
    • All patients who accept to share in the research.

Exclusion Criteria:

  • • Ages below 20 years.

    • Patients with severe cardiovascular and cerebrovascular diseases.
    • Mental illness that is difficult to diagnose and treat.
    • Surgery within the past month.
    • Patients with acute infections.
    • Pregnancy.
    • Presence of malignancy.
    • Undergoing fracture treatment, and serious mobility.
    • patients with eye problems.

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
adult patients on regular hemodialysis on assiut university hospitals
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of predictive factors significantly associated with post-dialysis fatigue
Time Frame: about 2 years
Demographic, clinical, psychological factors significantly associated with post-dialysis fatigue.
about 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of the most effective assessment tool for measuring post dialysis fatigue.
Time Frame: about 2 years
assessment tool for measuring post dialysis fatigue by using recovery time recovery time of post dialysis is time to recover from hemodialysis
about 2 years
Estimated prevalence of post-dialysis fatigue in the study population.
Time Frame: about 2 years
by using a questionnaire
about 2 years
Estimated severity of post-dialysis fatigue in the study population.
Time Frame: about 2 years
by using questionnaire
about 2 years

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: christina kamel hanaa, master degree, Faculty of Medicine Assuit University
  • Study Director: Hoida AbdAlhakam Nafady, professor, Faculty of Medicine Assuit University
  • Study Director: Noha Gamal Abd Elmalek, doctor, Faculty of Medicine Assuit 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

Helpful Links

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 (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 16, 2025

First Submitted That Met QC Criteria

April 19, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • post-dialysis fatigue

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

it will be discussed with my supervisoirs

Study Data/Documents

  1. Study Protocol
    Information identifier: Not available at moment
    Information comments: Most of the informations available at This site and Google Scholar

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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