Skip to main content
OpenTrials
Completed

NCT Number: NCT07535957

Nurse-Led Nutrition and Exercise Program for Hemodialysis Patients

This randomized controlled trial aims to evaluate the effectiveness of a nurse-led integrated nutrition and exercise intervention on improving health-related quality of life among hemodialysis patients. Patients undergoing maintenance hemodialysis often experience reduced quality of life due to physical, psychological, and dietary challenges.

In this study, participants are randomly assigned to either an intervention group receiving a structured nurse-led program that includes individualized nutritional counseling and supervised exercise sessions, or a control group receiving usual hemodialysis care. The intervention is designed to enhance patients' physical function, nutritional status, and overall well-being.

The primary outcome is the change in quality of life measured using a validated instrument over a defined follow-up period. The findings of this study may provide evidence for the integration of nurse-led lifestyle interventions into routine hemodialysis care to improve patient outcomes

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Shaheed Al-Sadr Teaching Hospital - Hemodialysis Unit, Al-Nasiriya Teaching Hospital - Hemodialysis Unit, and Al-Zubair Dialysis Center

Amarah, Maysan Governorate, 62001, Iraq

About this study

Hemodialysis patients commonly experience multiple physical, psychological, and social challenges that negatively affect their quality of life. These challenges include fatigue, reduced physical activity, dietary restrictions, and comorbid conditions. Despite advances in dialysis care, improving quality of life remains a key clinical priority.

This study is a multi-center, parallel-group randomized controlled trial conducted to assess the effectiveness of a nurse-led integrated nutrition and exercise intervention among patients undergoing maintenance hemodialysis. A total of 120 participants were enrolled and randomly allocated into two groups: an intervention group and a control group.

The intervention group received a structured program delivered by trained nurses, which included individualized nutritional counseling based on dialysis-specific dietary recommendations and a supervised exercise regimen tailored to patient tolerance and clinical condition. The program aimed to improve dietary adherence, enhance physical activity, and promote overall health.

The control group received routine hemodialysis care without additional structured intervention.

The primary outcome measure was the change in health-related quality of life assessed using the Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire. Secondary outcomes included changes in nutritional status, physical activity levels, and selected clinical parameters.

Data were collected at baseline and after the intervention period, and appropriate statistical analyses were conducted to compare outcomes between groups.

This study aims to provide evidence on the role of nurse-led interventions in improving the quality of life of hemodialysis patients and to support the integration of holistic care approaches into routine clinical practice.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants were included if they met the following criteria: Age ≥ 18 years, of either sex; Receiving maintenance hemodialysis for ≥ 6 months; Regular attendance at the dialysis center ; and Willingness to participate and provide informed consent.

Exclusion criteria

  • The patients were excluded if they: Refused to participate in the study, and had other chronic diseases that could interfere with the study outcomes

Treatment and study plan

Nurse-Led Integrated Nutrition and Exercise Program

Behavioral

This intervention is a structured nurse-led integrated program designed for hemodialysis patients, combining individualized nutritional counseling and supervised exercise sessions. The nutritional component focuses on dietary management appropriate for dialysis patients, while the exercise component includes low-to-moderate intensity physical activity tailored to patient tolerance. The intervention aims to improve health-related quality of life, physical function, and overall well-being in addition to routine hemodialysis care.

Other names: Nutrition Education Program

Usual Hemodialysis Care

Other

Participants in the control group receive routine hemodialysis care provided by the dialysis center without additional structured nutrition or exercise intervention

Other names: Routine Care

Primary outcomes

  1. Improvement in Health-Related Quality of Life (HRQoL) Using Validated Scale (e.g., WHOQOL-70)

    Time frame: Baseline and 12 weeks after intervention

    The primary outcome is the change in health-related quality of life among hemodialysis patients following a nurse-led integrated nutrition and exercise intervention, measured using the Kidney Disease Quality of Life-70 (WHOQOL-70) questionnaire

Sponsors and collaborators

Lead sponsor

University of Misan

Other

Registry information

Official study title

Effectiveness of a Nurse-Led Integrated Nutrition and Exercise Intervention on Quality of Life Among Hemodialysis Patients: A Randomised Controlled Trial

Acronym: HD-NEX

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 17, 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.

Published trials that share one or more normalized conditions with this study.