Nurse-Led Nutrition and Exercise Program for Hemodialysis Patients (HD-NEX)

April 10, 2026 updated by: Aqeel Azeez Arrar, University of Misan

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • Maysan Governorate
      • Amarah, Maysan Governorate, Iraq, 62001
        • Al-Shaheed Al-Sadr Teaching Hospital - Hemodialysis Unit, Al-Nasiriya Teaching Hospital - Hemodialysis Unit, and Al-Zubair Dialysis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group: Nurse-Led Nutrition and Exercise Intervention Group
A structured nurse-led program including individualized nutritional counseling and supervised exercise sessions designed to improve health-related quality of life in hemodialysis patients
Behavioral: Nurse-Led Integrated Nutrition and Exercise Program
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
Other: Usual Hemodialysis Care
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
No Intervention: Control Group: Usual Standard Care Group
Routine hemodialysis care provided by the dialysis center without additional structured nutrition or exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 12 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Misan

Investigators

  • Principal Investigator: Aqeel Azeez Arrar, PH. D., University of Misan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

October 22, 2025

Study Completion (Actual)

February 15, 2026

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOMisan-HD-QOL-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to patient confidentiality and privacy considerations. The dataset includes sensitive clinical information of hemodialysis patients, and sharing IPD may pose risks to patient privacy. Only aggregated and de-identified results will be reported in publications and presentations

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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