Lifestyle Modification Programme for Patients With Peripheral Arterial Disease
- Conditions
- Peripheral Arterial Occlusive Disease
- Interventions
- Behavioral: Risk Factors Modification ProgrammeBehavioral: Standard Healthcare
- Registration Number
- NCT03935776
- Lead Sponsor
- Western Vascular Institute, Ireland
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 208
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Aged 18 years or more
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Provide written informed consent
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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)
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Symptomatic PAD (Rutherford category 2 and above(11)
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Patients should have at least one of the following risk factors:
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Blood pressure > 140/80 mmHg
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Fasting Blood Sugar (FBS) >53 mmol/mol
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HbA1c >7%
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Total cholesterol >5 mmol/L
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LDL cholesterol >2.6 mmol/L
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Triglycerides >1.7 mmol/L
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HDL <1.0 mmol/L in men and <1.2 mmol/L in women
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Physical activity less 30 minutes for 5 days per week
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BMI 25>kg/m2
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Waist circumference >80 cm in women, and >94 cm in men.
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Current smoker or exposure to tobacco in any form
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Unhealthy diet, Mediterranean diet score less than 10 points
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Risk Factors Modification Programme Risk Factors Modification Programme * Patients in the intervention arm will attend a 12-week intensive lifestyle programme. * The intervention includes weekly exercise class and educational workshops, serial blood pressure, body mass index, glucose and lipid measurements. * Weekly multidisciplinary team meetings and targeted and protocol pharmacotherapy to support lifestyle changes. Standard Healthcare Standard Healthcare The control group will receive information and advice to the patients to modify their lifestyles but without providing a structured intervention or an individualised plan.
- Primary Outcome Measures
Name Time Method Lifestyle and medical risk factor modification 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
- Secondary Outcome Measures
Name Time Method Amputation free survival 1 year if the patient underwent a major amputation and level of amputation
Re-intervention or stenosis rate 1 year Any re-intervention or stenosis among patients who already underwent vascular surgery
Freedom from major adverse cardiovascular events (MACE) and major adverse limb events (MALE) 1 year If the patient developed a major adverse cardiovascular event (MACE) or major adverse limb event (MALE)
Revascularisation-free survival 1 year if the patient underwent any revascularisation procedure
Health related quality of life 1 year assessed using the Dartmouth Cooperative Information Project (COOP) charts at enrolment and after one year.
The COOP charts measure six core aspects of functional status: physical fitness, feelings, daily activities, social activities, change in health, pain, and overall health. The instrument consists of six charts, referring to the above mentioned aspects of functioning. Each chart consists of a simple title, a question referring to the status of the patient and an ordinal five-point response scale illustrated with a simple drawing.
Each item is rated on this five-point ordinal scale ranging from 1 (no limitation at all) to 5 (severely limited); for 'change in health' score 1 means 'much better' and score 5 'much worse'. The designers do not advocate summing the responses to gain a single index figure of health status.
Trial Locations
- Locations (1)
Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital
🇮🇪Galway, Ireland