Post-dialysis FatigueNCT06947681
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
An observational study of Post-dialysis Fatigue, run by Assiut University.
Trial summary
To improve the quality of life of hemodialysis patients and provide better control for post dialysis fatigue in regular hemodialysis patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Post-dialysis Fatigue
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients on regular hemodialysis on hemodialysis unit of assiut university hospital
Who may be able to join
- • 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.
Who cannot join
- • 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.
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- Presence of malignancy.
- Undergoing fracture treatment, and serious mobility.
- patients with eye problems.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-dialysis Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adult patients on regular hemodialysis on assiut university hospitals | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of predictive factors significantly associated with post-dialysis fatigue
Demographic, clinical, psychological factors significantly associated with post-dialysis fatigue.
Measured: about 2 years
Secondary outcomes (3)
Determination of the most effective assessment tool for measuring post dialysis fatigue.
assessment tool for measuring post dialysis fatigue by using recovery time recovery time of post dialysis is time to recover from hemodialysis
Measured: about 2 years
Estimated prevalence of post-dialysis fatigue in the study population.
by using a questionnaire
Measured: about 2 years
Estimated severity of post-dialysis fatigue in the study population.
by using questionnaire
Measured: about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-dialysis FatigueStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Kamel Hanna Soliman, Assiut University
- Investigators
- christina kamel hanaa, master degree, Principal investigator, Assiut UniversityHoida AbdAlhakam Nafady, professor, Study director, Assiut UniversityNoha Gamal Abd Elmalek, doctor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947681
- Sponsor's protocol ID
- post-dialysis fatigue
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: it will be discussed with my supervisoirs
Publications
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
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.
PubMed 37311633Sklar 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.
PubMed 9158212Faioli 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.
PubMed 39221326
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Predicting and Assessment of Post Dialysis Fatigue in Patients on Regular Hemodialysis in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06947681
- Acronym / sponsor ID
- post-dialysis fatigue
- Conditions
- Post-dialysis Fatigue
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients on regular hemodialysis on assiut university hospitals | – | –no intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients on regular hemodialysis on hemodialysis unit of assiut university hospital
Key inclusion criteria (7 listed)
- • End stage renal diseases (ESRD) patients who receive hemodialysis 3 times a week for 4 h each time.
Key exclusion criteria (9 listed)
- • Ages below 20 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Determination of the most effective assessment tool for measuring post dialysis fatigue.
Time frame: about 2 years
Estimated prevalence of post-dialysis fatigue in the study population.
Time frame: about 2 years
Estimated severity of post-dialysis fatigue in the study population.
Time frame: about 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Results publicationKodama, 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
- Results publication: PubMed 37311633Dou 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.
- Results publication: PubMed 9158212Sklar 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.
- Results publication: PubMed 39221326Faioli 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.
- Website for a linked papers and articlesLink provided by the sponsor.
- Search engine that' includes research similar articles or papersLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. it will be discussed with my supervisoirs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
christina kamel hanaa, master degree principal investigator
Assiut University
Hoida AbdAlhakam Nafady, professor study director
Assiut University
Noha Gamal Abd Elmalek, doctor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Post-dialysis Fatigue, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact christina kamel hanaa, master degree (+201202316730, Christinakamel66@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of predictive factors significantly associated with post-dialysis fatigue (time frame: about 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06947681, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.