Effectiveness of a Nurse-Led Integrated Nutrition and Exercise Intervention on Quality of Life Among Hemodialysis Patients: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Improvement in Health-Related Quality of Life (HRQoL) Using Validated Scale (e.g., WHOQOL-70)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking is applied. Both participants and investigators are aware of group assignments due to the nature of the behavioral intervention
入排标准
- 年龄范围
- 21 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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.
排除标准
- •The patients were excluded if they: Refused to participate in the study, and had other chronic diseases that could interfere with the study outcomes
研究组 & 干预措施
Control Group: Usual Standard Care Group
Routine hemodialysis care provided by the dialysis center without additional structured nutrition or exercise program
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
干预措施: Nurse-Led Integrated Nutrition and Exercise Program (Behavioral)
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
干预措施: Usual Hemodialysis Care (Other)
结局指标
主要结局
Improvement in Health-Related Quality of Life (HRQoL) Using Validated Scale (e.g., WHOQOL-70)
时间窗: 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
次要结局
未报告次要终点
研究者
Aqeel Azeez Arrar
Assistant Professor, Faculty of Nursing, University of Misan
University of Misan