End-Stage Renal Disease; HemodialysisHD-NEXNCT07535957
Nurse-Led Nutrition and Exercise Program for Hemodialysis Patients
A study testing Nurse-Led Integrated Nutrition and Exercise Program and Usual Hemodialysis Care in people with End-Stage Renal Disease; Hemodialysis, run by University of Misan at 1 site in Iraq.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 59 years
- Conditions the study is for
- End-Stage Renal Disease; Hemodialysis
- What is being tested?
- Nurse-Led Integrated Nutrition and Exercise Program and Usual Hemodialysis Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIraq
- Study dates
- 1 Apr 2025to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- The patients were excluded if they: Refused to participate in the study, and had other chronic diseases that could interfere with the study outcomes
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Al-Shaheed Al-Sadr Teaching Hospital - Hemodialysis Unit, Al-Nasiriya Teaching Hospital - Hemodialysis Unit, and Al-Zubair Dialysis Center
Amarah, Maysan Governorate, 62001
About this study
Official title: 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
Read the 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.
- Conditions
- End-Stage Renal Disease; Hemodialysis
- Being tested
- Nurse-Led Integrated Nutrition and Exercise Program, Usual Hemodialysis Care
- Keywords
- Nurse-Led Intervention, Nutrition Counseling, Exercise Program, Quality of Life, Hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Integrated Nutrition and Exercise ProgramBehavioural
Also called Nutrition Education 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.
Usual Hemodialysis CareOther
Also called Routine Care
Participants in the control group receive routine hemodialysis care provided by the dialysis center without additional structured nutrition or exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Nurse-Led Nutrition and Exercise Intervention Group | Experimental | A structured nurse-led program including individualized nutritional counseling and supervised exercise sessions designed to improve health-related quality of life in hemodialysis patients Receives: Behavioral: Nurse-Led Integrated Nutrition and Exercise Program; Other: Usual Hemodialysis Care |
| Control Group: Usual Standard Care Group | No intervention | Routine hemodialysis care provided by the dialysis center without additional structured nutrition or exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Health-Related Quality of Life (HRQoL) Using Validated Scale (e.g., WHOQOL-70)
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
Measured: Baseline and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Apr 2025
- Primary completion22 Oct 2025
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal Disease; HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel-group randomized controlled trial in which participants are assigned to either a nurse-led integrated nutrition and exercise intervention group or a usual care control group and followed concurrently
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Misan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aqeel Azeez Arrar, University of Misan
- Investigators
- Aqeel Azeez Arrar, PH. D., Principal investigator, University of Misan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535957
- Sponsor's protocol ID
- UOMisan-HD-QOL-2026-01
- Acronym
- HD-NEX
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Nurse-Led Integrated Nutrition and Exercise Intervention on Quality of Life Among Hemodialysis Patients: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07535957
- Acronym / sponsor ID
- HD-NEX / UOMisan-HD-QOL-2026-01
- Conditions
- End-Stage Renal Disease; Hemodialysis
- Keywords
- Nurse-Led Intervention, Nutrition Counseling, Exercise Program, Quality of Life, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of MisanUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A parallel-group randomized controlled trial in which participants are assigned to either a nurse-led integrated nutrition and exercise intervention group or a usual care control group and followed concurrently
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Nurse-Led Nutrition and Exercise Intervention Group | Experimental | Behavioral: Nurse-Led Integrated Nutrition and Exercise Program, Other: Usual Hemodialysis CareA structured nurse-led program including individualized nutritional counseling and supervised exercise sessions designed to improve health-related quality of life in hemodialysis patients |
| Control Group: Usual Standard Care Group | No intervention | –Routine hemodialysis care provided by the dialysis center without additional structured nutrition or exercise program |
Who may qualify
- Ages
- 21 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The patients were excluded if they: Refused to participate in the study, and had other chronic diseases that could interfere with the study outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-Led Integrated Nutrition and Exercise ProgramAlso: Nutrition Education ProgramThis 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. | Behavioural | Intervention Group: Nurse-Led Nutrition and Exercise Intervention Group |
| Usual Hemodialysis CareAlso: Routine CareParticipants in the control group receive routine hemodialysis care provided by the dialysis center without additional structured nutrition or exercise intervention | Other | Intervention Group: Nurse-Led Nutrition and Exercise Intervention Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aqeel Azeez Arrar, PH. D. principal investigator
University of Misan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Integrated Nutrition and Exercise Program and Usual Hemodialysis Care in people with End-Stage Renal Disease; Hemodialysis, run by University of Misan at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Health-Related Quality of Life (HRQoL) Using Validated Scale (e.g., WHOQOL-70) (time frame: Baseline and 12 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.