Effect of Intradialytic Exercise Among Hemodialysis Patients in the United Arab Emirates on Cardio-Metabolic Markers, Dialysis Adequacy, Quality of Life and Cost Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Urea Reduction Ratio (URR) (mmol/L)
研究概览
简要总结
Hemodialysis (HD) patients have decreased physical functioning, diminished muscle mass and altered muscle quality thus the increased mortality rate compared to their age-matched population. Risk factors include their sedentary lifestyle and altered nutritional status [1]; the sedentary lifestyle or the lack of exercise is known to be a risk factor for cardiovascular complications [2] and contributes to worsen protein energy wasting (PEW), which is described as the loss of body protein mass and fuel reserves [1]. Therefore the health of the HD patients and consequently their quality of life (QOL) is deteriorated.
Studies have shown that aerobic exercise during HD improves aerobic capacity, blood pressure, heart rate, muscular strength, dialysis efficacy and quality of life; however, such studies were not done on the United Arab Emirates (UAE) HD patients and there is no protocol for implementing exercise in the UAE HD units [3-4]
Hypothesis: Intradialytic aerobic exercise will result in significantly improved clinical, cardio-metabolic and quality of life outcomes and reduced cost of care.
Primary objective of the study:
- To investigate whether the intradialytic exercise (IDE) within the routine practice of hemodialysis in the UAE will improve adequacy of dialysis.
Secondary objectives of the study:
- To study the effect of clinical and cardio-metabolic outcomes of the HD patients.
- Explore whether the trial would improve the cost effectiveness of this patient population's health care
- Define the nature of the IDE programs (intensity, duration, modality), and feasibility of its application in routine setting.
Importance of this research:
- Pioneering research in the Middle East and Gulf Cooperation Council (GCC) countries where the effect of intradialytic exercise will be studied for the first time on Arab population.
- It will contribute in identifying the exact strategies to integrate within the hemodialysis unit to improve clinical and cardio-metabolic outcomes, quality of life and healthcare cost.
Usefulness of this research to the UAE
- It will improve the health care cost and reduce cost wastage in the UAE (lean management).
- It will put UAE on the pedestal in front of other countries in integrating innovative methods for a better care of hemodialysis patients.
详细描述
Each patient will be asked to follow an Intradialytic aerobic low intensity exercise program of 45 minutes per each HD session throughout the 6-month study duration. The exercise will be tailored to each HD patient's ability (measured by VO2Max), supervised by the hospital physiotherapist and the research team. Continuous support and encouragement to the patients will be provided to assure they complete the 45 minutes of exercise on each HD session. Additionally, patients will be educated on the health benefits of exercise and how to integrate safe exercise into their daily life (by the research assistants).
Research assistants will be trained by the principal investigator (PI) on the study instruments and data collection methods. These assistants will administer 4 questionnaires (5 minutes each) for each HD patient separately and will collect data from the medical chart of each patient. The assessment will take place during the HD session.
The research assistants will also collect from the patient's file blood test results on a monthly basis (relevant to the study mentioned in table1); additional needed parameters will be analysed from the same blood sample that the hospital already collect for the patients monitoring, and will be analysed by the hospital for a fee from the research fund. For the β-aminoisobutyric acid (BAIBA) tests - cardiometabolic marker, 5 ML of the blood sample from each patient will be transported to a specialized lab for analysis.
All of the parameters, except the demographics (collected only at t0), will be collected and monitored at 3 time points: Baseline (t0), post-intervention (t1) and follow up (t2).
Assessment tools include
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HD patients from the selected HD units in the UAE on HD 3 times a week
- •Stable on HD (free of life -threatening acute or chronic disease, with a life expectancy of > 6 months)
- •≥ 3 months on HD
- •The gender being irrespective (age ≥ 18)
- •Not practicing any physical activity
- •With no recent hospitalization (in the last 3 months for ACUTE condition)
- •At their full capacity of cognitive, psychiatric and physical ability for self-care and communication
- •Capable to communicate either verbally or through writing
- •Fully aware of the proposed protocol of the study, and able to provide a consent form.
- •All selected patients should have received clearance from their nephrologist and cardiologist that they are eligible to start an exercise program
排除标准
- •Patients not meeting the inclusion criteria listed above
- •Patients not able to perform the exercise program
- •Patients who did not receive the clearance of the attending nephrologist of the unit to participate in the study
研究组 & 干预措施
Interventional Participants
Patients will represent their own controls (pre and post intervention), in the HD unit of Al Qassimi Hospital, Sharjah, United Arab Emirates.
干预措施: Intradialytic aerobic low intensity exercise (Other)
结局指标
主要结局
Urea Reduction Ratio (URR) (mmol/L)
时间窗: Baseline (average of the last 6 months), Week #9,14,18,22,27,31, and at 1 year post intervention
it is blood urea nitrogen taken pre and post a dialysis session
次要结局
- Exercise Behavior questionnaire(at baseline, end of 6 month intervention, and at 1 year post intervention)
- Quality of Life(at baseline, end of 6 month intervention, and at 1 year)
- Malnutrition- Inflammation Syndrome(at baseline, end of 6 month intervention, and at 1 year post intervention)
- Exercise Fitness Level(Week #1,9,14,18,22,27,31)
- β-aminoisobutyric acid (μM)(at baseline and at post 6 month intervention)
- Serum Phosphorous (mmol/L)(Baseline (average of the past 6 months), Week #9,14,18,22,27,31, and at 1 year post intervention)
研究者
Mirey Karavetian
Assistant Professor
Zayed University