Intradialytic Versus Home-Based Exercise in Female Hemodialysis Patients

NCT07716436 | Completed

• 1 other identifier: 36264PR1100/2/25
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Failure, Chronic; Renal Dialysis

Keywords

Exercise; Hemodialysis; Quality of Life; Self-Esteem; Sexual Function

Outcome Measures

Primary Outcomes (3)

• Health-Related Quality of Life

  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.

  Baseline and 12 weeks

• Self-Esteem

  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.

  Baseline and 12 weeks

• Female sexual function

  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.

  Baseline and 12 weeks

Study Arms (3)

Intradialytic Exercise

EXPERIMENTAL

Participants performed low- to moderate-intensity aerobic and resistance exercises during the first two hours of hemodialysis, three times per week for 12 weeks. Each session included a 5-minute warm-up, followed by aerobic and resistance exercises. The conditioning phase started at 10 minutes and gradually increased to 30 minutes according to tolerance, followed by 5 minutes of relaxation and breathing exercises. Exercise intensity was maintained at 60%-70% of maximal heart rate and monitored using the Borg scale. Sessions were supervised by a trained dialysis nurse.

Behavioral: Intradialytic Exercise

Home-Based Exercise

EXPERIMENTAL

Participants performed a structured home-based exercise program for 30 minutes per day, at least three to five times per week, for 12 weeks. The program included walking, bodyweight resistance exercises, and flexibility routines. Participants received instructions on safe exercise performance and were advised to adjust the exercise intensity according to tolerance.

Behavioral: Home-Based Exercise

Control

NO INTERVENTION

Participants continued their usual hemodialysis care without a structured exercise program during the 12-week study period.

Interventions

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.

Intradialytic Exercise

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.

Home-Based Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbia Governorate, 31511, Egypt

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Nephrology and Internal Medicine

Model Details: Participants were randomly allocated in equal numbers to an intradialytic exercise group, a home-based exercise group, or a control group for 12 weeks.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: March 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning immediately after publication of the study results and continuing for 2 years.
• Access Criteria: De-identified individual participant data will be available to researchers who submit a methodologically sound proposal. Requests should be directed to the corresponding author at hebaelhabiby@gmail.com. Requests will be reviewed by the study investigators, and approved data will be provided for the purposes specified in the proposal, subject to an appropriate data use agreement.

Locations

EG (1)