Hemodialysis PatientNCT07555522
Gender-Based Differences In Dynamic Balance Among Hemodialysis Patients
An observational study of Hemodialysis Patient, run by Cairo University at 2 sites in Egypt.
Trial summary
Aim of the study is to investigate gender-based differences in dynamic balance in form of Timed-Up-and-Go and Five Times-sit-to-Stand-to-sit tests among hemodialysis patients. The main question it aims to answer is: Are there gender-based differences in dynamic balance in form of Timed-Up-and-Go and Five… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hemodialysis Patient
- How many people
- 155 participants
- Where
- 2 sitesEgypt
- Study dates
- 16 Apr 2026to 25 May 2026
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study will be conducted on 155 hemodialysis patients divided into 2 study groups; group A (62 female patients) and group B (93 male patients). Patients with age ranged from 20 to 60 years old and BMI from 18.5 to 29.9 kg/m2. All patients have been undergoing hemodialysis three times per week for at least 1 year; without secondary disorders that may affect balance assessment.
Who may be able to join
- Age 20 to 60 years (both sexes)
- Body mass index (BMI) 18.5 to 29.9 kg/m²
- Undergoing hemodialysis three times per week
- Duration of hemodialysis ≥1 year
- No exercise therapy within the last 3 months
- Able to walk independently for at least 2 minutes without assistive devices
Who cannot join
- Recent myocardial infarction (within 6 weeks)
- Malignant arrhythmia or unstable angina
- History of major surgery or fracture of the hip/knee, or hip/knee replacement
- Severe respiratory or cardiovascular conditions affecting cardiopulmonary function
- Severe hypotension during or after hemodialysis
- Neurological disorders affecting balance
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nada Elmetwaly Elbatal, MSc candidate contact
Egypt2 sites
Tanta General Hospital
Tanta
Tanta General Hospital
Tanta
Rasha Abdelbaath Elgammal, MD, +01069845306, rashaabd8@gmail.com
About this study
Aim of the study is to investigate gender-based differences in dynamic balance in form of Timed-Up-and-Go and Five Times-sit-to-Stand-to-sit tests among hemodialysis patients. The main question it aims to answer is:
Are there gender-based differences in dynamic balance in form of Timed-Up-and-Go and Five Times-sit-to-Stand-to-sit tests among hemodialysis patients?
Read the detailed description
Kidney disease is a prevalent renal disorder affecting a significant proportion of the global population, creating major challenges for health, quality of life and economic burden. Kidney disease is characterized by an irregularity in kidney structure or function that may manifest suddenly and can either resolve or progress to a chronic state. Chronic Kidney Disease (CKD) is a broad term for several illnesses characterized by varied clinical manifestations with kidney failure being the most severe consequence, demanding treatment only through dialysis or transplantation.
Hemodialysis is characterized by the diffusion of solutes via a semipermeable membrane, with the objective of restoring the homeostatic balance of intracellular and extracellular fluids, as typically regulated by healthy kidneys. Although hemodialysis is essential for life in patients with advanced CKD, it is associated with significant impairments in balance.
Several studies have consistently shown that individuals receiving hemodialysis suffer from balance control deficits. These include greater postural sway, diminished dynamic stability, and slow prolonged sit-to-stand performance, even in individuals who self-report satisfactory physical function.
Balance impairment in hemodialysis patients is attributed to proprioceptive sensory impairments, diminished lower-limb muscle strength, and neuromuscular dysfunction. Moreover, high-risk sarcopenia has been demonstrated to connect with compromised dynamic balance, evidenced by reduced gait speed, diminished stride length, extended double support phase, and elevated Timed-Up-and-Go (TUG) test durations.
Balance is typically classified into static balance and dynamic balance. Both are affected in active hemodialysis patients but impairment in dynamic balance is a more important predictor of accidental falls in these patients .
Falls are a major health concern among hemodialysis patients, with a prevalence significantly higher than that in the general population. 27.1% of hemodialysis patients experience falls. Among those followed up for over 12 months, the rate rises to 28.8%, with 14.8% having repeated falls. Significantly, despite the patients' young age, their risk of repeated falls was equivalent to that commonly observed in older persons, highlighting the significant fall risk linked to hemodialysis regardless of age. Falls in hemodialysis patients increase the risk of injury, reduce quality of life, and contribute to higher mortality rates. These findings emphasize the importance of routinely assessing motor function as part of comprehensive healthcare for hemodialysis patients to better develop interventions and improve patient outcomes.
Considering the significant implications of dynamic balance impairment, it is essential to examine aspects such as gender differences, which may affect dynamic balance performance and total motor function in hemodialysis patients.
- Conditions
- Hemodialysis Patient
- Keywords
- Balance
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 |
|---|---|---|
| Male Hemodialysis Patients | Group 1 Name: Male Hemodialysis Patients Description: Male patients undergoing maintenance hemodialysis 3 times per week who will be assessed for dynamic balance using the Timed Up and Go and Five Times Sit-to -Stand-to-Sit tests. | |
| Female Hemodialysis Patients | Group 2 Name: Female Hemodialysis Patients Description: Female patients undergoing maintenance hemodialysis 3 times per week who will be assessed for dynamic balance using the Timed Up and Go and Five Times Sit-to -Stand-to-Sit tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Balance among Hemodialysis Patients
Assessed using Timed-Up-and-Go test . Each participant will perform the Timed-Up-and-Go test twice, and the shortest completion time (in seconds) will be recorded.
Measured: At baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start16 Apr 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion25 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis PatientStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Elmetwaly Mostafa Elbatal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555522
- Sponsor's protocol ID
- HD-Balance-Gender-2026
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blake C, O'Meara YM. Subjective and objective physical limitations in high-functioning renal dialysis patients. Nephrol Dial Transplant. 2004 Dec;19(12):3124-9. doi: 10.1093/ndt/gfh538. Epub 2004 Oct 19.
PubMed 15494354
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender-Based Differences In Dynamic Balance Among Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07555522
- Acronym / sponsor ID
- HD-Balance-Gender-2026
- Conditions
- Hemodialysis Patient
- Keywords
- Balance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Apr 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 25 May 2026 (estimated)
- First posted
- 29 Apr 2026 (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.
Aim of the study is to investigate gender-based differences in dynamic balance in form of Timed-Up-and-Go and Five Times-sit-to-Stand-to-sit tests among hemodialysis patients. The main question it aims to answer is:
Are there gender-based differences in dynamic balance in form of Timed-Up-and-Go and Five Times-sit-to-Stand-to-sit tests among hemodialysis patients?
Detailed description
Kidney disease is a prevalent renal disorder affecting a significant proportion of the global population, creating major challenges for health, quality of life and economic burden. Kidney disease is characterized by an irregularity in kidney structure or function that may manifest suddenly and can either resolve or progress to a chronic state. Chronic Kidney Disease (CKD) is a broad term for several illnesses characterized by varied clinical manifestations with kidney failure being the most severe consequence, demanding treatment only through dialysis or transplantation.
Hemodialysis is characterized by the diffusion of solutes via a semipermeable membrane, with the objective of restoring the homeostatic balance of intracellular and extracellular fluids, as typically regulated by healthy kidneys. Although hemodialysis is essential for life in patients with advanced CKD, it is associated with significant impairments in balance.
Several studies have consistently shown that individuals receiving hemodialysis suffer from balance control deficits. These include greater postural sway, diminished dynamic stability, and slow prolonged sit-to-stand performance, even in individuals who self-report satisfactory physical function.
Balance impairment in hemodialysis patients is attributed to proprioceptive sensory impairments, diminished lower-limb muscle strength, and neuromuscular dysfunction. Moreover, high-risk sarcopenia has been demonstrated to connect with compromised dynamic balance, evidenced by reduced gait speed, diminished stride length, extended double support phase, and elevated Timed-Up-and-Go (TUG) test durations.
Balance is typically classified into static balance and dynamic balance. Both are affected in active hemodialysis patients but impairment in dynamic balance is a more important predictor of accidental falls in these patients .
Falls are a major health concern among hemodialysis patients, with a prevalence significantly higher than that in the general population. 27.1% of hemodialysis patients experience falls. Among those followed up for over 12 months, the rate rises to 28.8%, with 14.8% having repeated falls. Significantly, despite the patients' young age, their risk of repeated falls was equivalent to that commonly observed in older persons, highlighting the significant fall risk linked to hemodialysis regardless of age. Falls in hemodialysis patients increase the risk of injury, reduce quality of life, and contribute to higher mortality rates. These findings emphasize the importance of routinely assessing motor function as part of comprehensive healthcare for hemodialysis patients to better develop interventions and improve patient outcomes.
Considering the significant implications of dynamic balance impairment, it is essential to examine aspects such as gender differences, which may affect dynamic balance performance and total motor function in hemodialysis patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male Hemodialysis Patients | – | –Group 1 Name: Male Hemodialysis Patients Description: Male patients undergoing maintenance hemodialysis 3 times per week who will be assessed for dynamic balance using the Timed Up and Go and Five Times Sit-to -Stand-to-Sit tests. |
| Female Hemodialysis Patients | – | –Group 2 Name: Female Hemodialysis Patients Description: Female patients undergoing maintenance hemodialysis 3 times per week who will be assessed for dynamic balance using the Timed Up and Go and Five Times Sit-to -Stand-to-Sit tests. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study will be conducted on 155 hemodialysis patients divided into 2 study groups; group A (62 female patients) and group B (93 male patients). Patients with age ranged from 20 to 60 years old and BMI from 18.5 to 29.9 kg/m2. All patients have been undergoing hemodialysis three times per week for at least 1 year; without secondary disorders that may affect balance assessment.
Key inclusion criteria (6 listed)
- Age 20 to 60 years (both sexes)
- Body mass index (BMI) 18.5 to 29.9 kg/m²
- Undergoing hemodialysis three times per week
- Duration of hemodialysis ≥1 year
- No exercise therapy within the last 3 months
Key exclusion criteria (6 listed)
- Recent myocardial infarction (within 6 weeks)
- Malignant arrhythmia or unstable angina
- History of major surgery or fracture of the hip/knee, or hip/knee replacement
- Severe respiratory or cardiovascular conditions affecting cardiopulmonary function
- Severe hypotension during or after hemodialysis
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
Dynamic Balance among Hemodialysis Patients
Time frame: At baseline (single assessment)
Assessed using Timed-Up-and-Go test . Each participant will perform the Timed-Up-and-Go test twice, and the shortest completion time (in seconds) will be recorded.
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 29 Apr 2026.
- Background: PubMed 15494354Blake C, O'Meara YM. Subjective and objective physical limitations in high-functioning renal dialysis patients. Nephrol Dial Transplant. 2004 Dec;19(12):3124-9. doi: 10.1093/ndt/gfh538. Epub 2004 Oct 19.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nada Elmetwaly Elbatal, MSc candidate contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis Patient, run by Cairo University at 2 sites in Egypt.
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 6 inclusion and 6 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Nada Elmetwaly Elbatal, MSc candidate (+201002122937 ext. +0201002122931, nadaelbatal98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Balance among Hemodialysis Patients (time frame: At baseline (single assessment)). 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 NCT07555522, which also lists 1 linked publication.
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 29 Apr 2026.