Intradialytic Versus Home-Based Exercise in Female Hemodialysis Patients | NCT07716436

NCT07716436

Overview

NCT ID: NCT07716436
Lead Sponsor: Tanta UniversityOTHER
Official 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
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

Status and Timeline

Status: Completed
Last Update Posted: Jul 21, 2026Actual
Start Date: Mar 1, 2025Actual
Primary Completion Date: Jun 1, 2025Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 90Actual
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: Tanta University Hospitals

Similar Studies

Participant Group/Arms

Intradialytic ExerciseExperimental

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 ExerciseExperimental

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

ControlNo Intervention

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