Clinical trial NCT06947681: 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
Official title: Factors Predicting and Assessment of Post Dialysis Fatigue in Patients on Regular Hemodialysis in Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Post-dialysis Fatigue
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 155
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients on regular hemodialysis on hemodialysis unit of assiut university hospital

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identification of predictive factors significantly associated with post-dialysis fatigue
timeFrame: about 2 years
Secondary outcomes:
measure: Determination of the most effective assessment tool for measuring post dialysis fatigue.
timeFrame: about 2 years
measure: Estimated prevalence of post-dialysis fatigue in the study population.
timeFrame: about 2 years
measure: Estimated severity of post-dialysis fatigue in the study population.
timeFrame: about 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: christina kamel hanaa, master degree
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Hoida AbdAlhakam Nafady, professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Noha Gamal Abd Elmalek, doctor
role: STUDY_DIRECTOR
References:
citation: Kodama, H., Togari, T., Konno, Y. et al. A new assessment scale for post-dialysis fatigue in hemodialysis patients. Ren Replace Ther 6, 1 (2020). https://doi.org/10.1186/s41100-019-0252-5
citation: Dou J, Liu H, Ma Y, Wu YY, Tao XB. Prevalence of post-dialysis fatigue: a systematic review and meta-analysis. BMJ Open. 2023 Jun 13;13(6):e064174. doi: 10.1136/bmjopen-2022-064174.
citation: Sklar AH, Riesenberg LA, Silber AK, Ahmed W, Ali A. Postdialysis fatigue. Am J Kidney Dis. 1996 Nov;28(5):732-6. doi: 10.1016/s0272-6386(96)90256-5.
citation: Faioli A, Bergesio G, Sama C, Gallo B. Predictors of Fatigue Among Patients on Hemodialysis: An Observational Study. Cureus. 2024 Aug 1;16(8):e65953. doi: 10.7759/cureus.65953. eCollection 2024 Aug.