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Clinical Trials/NCT07555522
NCT07555522
Not yet recruiting
Not Applicable

Gender-Based Differences In Dynamic Balance Among Hemodialysis Patients

Cairo University1 site in 1 country155 target enrollmentStarted: April 16, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
155
Locations
1
Primary Endpoint
Dynamic Balance among Hemodialysis Patients

Overview

Brief 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 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

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nada Elmetwaly Mostafa Elbatal

Principal Investigator

Cairo University

Study Sites (1)

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