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NCT Number: NCT07716436

Intradialytic Versus Home-Based Exercise in Female Hemodialysis Patients

This randomized controlled trial compared intradialytic exercise with home-based exercise in married female patients receiving maintenance hemodialysis. Ninety participants were randomly assigned in equal numbers to an intradialytic exercise group, a home-based exercise group, or a control group. Both exercise programs continued for 12 weeks.

The study evaluated whether exercise performed during dialysis or at home could improve quality of life, self-esteem, sexual function, and selected clinical and laboratory outcomes. Quality of life was assessed using the 36-Item Short Form Survey, self-esteem using the Rosenberg Self-Esteem Scale, and sexual function using the Female Sexual Function Index. Laboratory assessments included calcium, phosphorus, intact parathyroid hormone, albumin, C-reactive protein, hemoglobin, sodium, and potassium.

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Key information

Conditions

Kidney Failure, Chronic Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Dialysis Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, Gharbia Governorate, 31511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients older than 18 years.
  • Clinically stable.
  • Receiving regular maintenance hemodialysis three times per week for at least three months.
  • Able to perform mild- to moderate-intensity exercise.

Exclusion criteria

  • Physical limitations preventing exercise.
  • Acute illness.
  • Unstable cardiovascular disease.
  • Severe orthopedic or neurological disorders.
  • Cognitive impairment affecting cooperation.
  • Dialysis instability.
  • Severe chronic kidney disease-mineral and bone disorder.
  • Significant anemia.
  • Retinal hemorrhage.
  • History of hyperthyroidism.

Treatment and study plan

Intradialytic Exercise

Behavioral

A supervised low- to moderate-intensity aerobic and resistance exercise program performed during the first two hours of hemodialysis, three times per week for 12 weeks.

Home-Based Exercise

Behavioral

A structured home-based exercise program consisting of walking, bodyweight resistance exercises, and flexibility routines for 30 minutes per day, at least three to five times per week for 12 weeks.

Primary outcomes

  1. Health-Related Quality of Life

    Time frame: Baseline and 12 weeks

    Change in Health-Related Quality of Life was assessed by the 36-Item Short Form Survey. The 36-Item Short Form Survey consists of 36 items covering eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, energy/fatigue, social functioning, role limitations due to emotional problems, and emotional well-being. Each domain is scored from 0 to 100, with 0 representing the lowest possible health status and 100 representing the highest possible health status. Higher scores indicate better health-related quality of life. The validated Arabic version was used.

  2. Self-Esteem

    Time frame: Baseline and 12 weeks

    Change in Self-Esteem was assessed by the Rosenberg Self-Esteem Scale. The Rosenberg Self-Esteem Scale consists of 10 items assessing global self-esteem, including five positively worded and five negatively worded statements. Higher total scores indicate higher self-esteem.

  3. Female sexual function

    Time frame: Baseline and 12 weeks

    Change in Female Sexual Function was assessed by the Female Sexual Function Index. The Female Sexual Function Index consists of 19 items covering six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. The total score ranges from 2 to 36, with higher scores indicating better sexual function. The validated Arabic version was used.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Comparing the Effect of Intradialytic and Home-Based Exercise on Health Outcomes, Quality of Life, Self-Esteem, and Sexual Function in Female Hemodialysis Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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