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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control Group: Usual Standard Care Group | No Intervention | Routine hemodialysis care provided by the dialysis center without additional structured nutrition or exercise program |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 12 weeks after intervention |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Aqeel Azeez Arrar, PH. D. | University of Misan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Shaheed Al-Sadr Teaching Hospital - Hemodialysis Unit, Al-Nasiriya Teaching Hospital - Hemodialysis Unit, and Al-Zubair Dialysis Center | Amarah | Maysan Governorate | 62001 | Iraq |
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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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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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
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No masking is applied. Both participants and investigators are aware of group assignments due to the nature of the behavioral intervention
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| 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 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |