Effects of Exercise and Dietary Counselling in Reducing the Cardiovascular Risk Score in Kidney Transplant Patients: KT- LIFESTYLE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Cardiovascular risk reduction
研究概览
简要总结
The goal of this clinical trial is to assess whether, over an observation period of 3 years, there is a reduction in cardiovascular risk, and the extent of this reduction, in a group of adult kidney transplant patients undergoing tailored exercise combined with dietary counselling compared to a group of patients following the 'standard of care'.
详细描述
The main questions it aims to answer are:
- Prescribed exercise and dietary counselling could reduce of at least 1% in the cardiovascular risk score (by Framingham score) and cardiovascular biomarkers in kidney transplant recipients?
- How much can a lifestyle intervention affect kidney function, quality of life and the gut microbiota in this patient population?
Researchers will compare kidney transplant recipients undergoing tailored exercise combined with dietary counselling compared to a group of patients following the 'standard of care' to see if there is a reduction in cardiovascular risk, BMI, inflammatory markers, improve of gut microbiota and perception of quality of life. In addition, a number of hospital admissions for important clinical events, the number of fatal and non-fatal cardiovascular events (MACE), and mortality from all causes will be assessed in the long term.
Participants will enroll from the Nephrology, Dialysis and Transplant Units and randomize in intervantion group (A) or control (B).
In group A/intervention, a tailored exercise programme combined with specific dietary counselling will be prescribed, in group B/control, generic advice on healthy lifestyles will be given (standard of care) without specific prescription.
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
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stabilised male and female kidney transplant patients (assessment by the referring transplant centre)
- •Minimum age, 30 years;
- •Maximum age, 69 years;
- •Period since transplantation: from 6 months (subject to clinical stability being achieved) to 10 years;
- •Organ function: eGFR (CKD-EPI formula) ≥ 30 mL/min/1.73m ;2
- •Obtaining informed consent;
排除标准
- •Patients unable to follow the prescription,
- •Recent acute cardiovascular event (< 2 months),
- •Unstable angina,
- •Hyperkinetic/hypokinetic arrhythmias not controlled by therapy, and with signs of haemodynamic impairment,
- •Severe aortic stenosis,
- •Heart failure NYHA class III-IV, FE < 40%,
- •Acute illnesses that limit physical activity,
- •Severe hypertension (basal BP ≥200/110 mm Hg),
- •Neuro-musculo-skeletal pathologies that may be aggravated by exercise,
- •Patients unwilling to change lifestyle;
- •Any form of substance abuse, psychiatric disorder or condition that, according to the investigator, can complicate communication between doctor and patient;
- •Pregnant women.
研究组 & 干预措施
Group A, lifestyle intervention
lifestyle intervention
干预措施: lifestyle intervention (Behavioral)
Group B
standard of care
结局指标
主要结局
Cardiovascular risk reduction
时间窗: From enrollment to the end of the treatment (3 years)
reduction of at least 1% in the cardiovascular risk score - Framingham score - over the observation time. This score estimates the risk of developing a cardiovascular event over a 10-year period and is calculated in relation to the outcome from the following identifiable variables in normal clinical practice: * Sex * Age * Systolic pressure value * Treatment for hypertension (yes/no) * Smoker (yes/no) * Diabetes (yes/no) * HDL value * Total cholesterol value
次要结局
- Renal function(From enrollment to the end of the treatment (3 years))
- Gut microbiota analysis(From enrollment to the end of the treatment (3 years))
- Inflammatory status(From enrollment to the end of the treatment (3 years))
- Quality of Life (QoL)(From enrollment to the end of the treatment (3 years))
- Adherence to the lifestyle intervention(From enrollment to the end of the treatment (3 years))
- Cost-effectiveness of a healthy lifestyle intervention(From enrollment to the end of the treatment (3 years))
- Cardiovascular biomarkers(From enrollment to the end of the treatment (3 years))