The Effect of Lifestyle and Risk Factor Modification on Occlusive Peripheral Arterial Disease Outcomes: Standard Healthcare vs Structured Programme
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Lifestyle and medical risk factor modification
研究概览
简要总结
This trial randomises patients with occlusive peripheral arterial disease, to be managed either by providing a 12-week structured lifestyle modification programme, or standard healthcare.
详细描述
Peripheral arterial disease (PAD) affects more than 200 million of the global population. PAD represents a marker for premature cardiovascular events.
Despite the high prevalence of PAD and the strong association with cardiovascular morbidity and mortality, patients with PAD are less likely to receive appropriate treatment for their atherosclerotic risk factors than those who are being treated for coronary artery disease.
Because PAD represents a peripheral manifestation of atherosclerosis, most traditional and novel cardiovascular risk factors are strongly associated with this condition. Smoking, diabetes, hyperlipidaemia, hypertension, unhealthy diet, and physical inactivity were identified as significant modifiable risk factors that should be targeted for secondary prevention.
Atherosclerotic risk factor identification and modification plays an important role in reducing the number of adverse outcomes among patients with atherosclerosis. Risk reduction therapy decreases the risk of cardiovascular mortality and morbidity in patients with PAD. Because of the efficacy of these techniques, several expert committees have recommended their use in patients with PAD. Despite clear guidelines, several studies have shown that patients with PAD are routinely undertreated for these risk factors, which may contribute to high rates of morbidity and mortality.
Our trial will evaluate the impact of a 12-week, structured lifestyle and risk factor modification programme on medical and lifestyle risk factors modification, as well as on clinical vascular outcomes, among patients with peripheral arterial disease. We will compare these outcomes to that of standard healthcare traditionally provided to this high-risk patient group.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinding of trial participants and care providers is not possible because of obvious differences between the interventions. However, the investigator, the outcomes assessor and statistician are blinded to treatment received.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or more
- •Provide written informed consent
- •PAD: diagnosed by at least one of the following:
- •Ankle-brachial index of less than 0.90 in at least one lower extremity(10)
- •Toe brachial index of less than 0.609
- •Evidence of arterial occlusive disease in one lower extremity detected by duplex ultrasonography, computed tomographic angiography, or magnetic resonance angiography(10)
- •Symptomatic PAD (Rutherford category 2 and above(11)
- •Patients should have at least one of the following risk factors:
- •Blood pressure > 140/80 mmHg
- •Fasting Blood Sugar (FBS) >53 mmol/mol
- •HbA1c >7%
- •Total cholesterol >5 mmol/L
- •LDL cholesterol >2.6 mmol/L
- •Triglycerides >1.7 mmol/L
- •HDL <1.0 mmol/L in men and <1.2 mmol/L in women
- •Physical activity less 30 minutes for 5 days per week
- •BMI 25>kg/m2
- •Waist circumference >80 cm in women, and >94 cm in men.
- •Current smoker or exposure to tobacco in any form
- •Unhealthy diet, Mediterranean diet score less than 10 points
排除标准
- •Rutherford category zero or one(11)
- •Involvement in another clinical trial in the previous six months
- •Legal incapacity
- •Inadequate English language
- •Significant cognitive impairment or mental illness
- •Inadequate English language
- •Significant cognitive impairment or mental illness
- •Refusal to participate in a certain part of the intervention
- •Mental and physical inability to participate in the structured programme
- •Pregnant (confirmed by β-human chorionic gonadotropion (HCG) analysis).
- •Contraindication to anticoagulation and antiplatelet medications or any of the risk factors treatment.
结局指标
主要结局
Lifestyle and medical risk factor modification
时间窗: at 12 weeks
Achieving target Improvement in lifestyle risk factors. Target improvement will be considered if the patient achieves any one or more of the following: 1. Smoking cessation 2. Body mass index 20-25 (kg/m\^2). BMI is calculated by dividing body weight in kilograms by the square of height in meters 3. Glycosylated haemoglobin (HbA1c) less than 7% 4. Total Cholesterol less than 5.0 mmol/L
次要结局
- Amputation free survival(1 year)
- Re-intervention or stenosis rate(1 year)
- Freedom from major adverse cardiovascular events (MACE) and major adverse limb events (MALE)(1 year)
- Revascularisation-free survival(1 year)
- Health related quality of life(1 year)