Lifestyle Modification Programme for Patients With Peripheral Arterial Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Lifestyle and Risk Factor Modification on Occlusive Peripheral Arterial Disease Outcomes: Standard Healthcare vs Structured Programme

Conditions
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Peripheral Arterial Occlusive Disease

Intervention / Treatment
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* Behavioral: Risk Factors Modification Programme
* Behavioral: Standard Healthcare


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomised, parallel group, active-control trial, with patients randomised in a 1:1 ratio
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Risk Factors Modification Programme<br>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. | Behavioral: Risk Factors Modification Programme<br>* 12- week supervised risk factor modification programme derived from the Euroaction study standards<br>|
| Active Comparator: Standard Healthcare<br>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. | Behavioral: Standard Healthcare<br>* Patients are advised to adjust lifestyle without the support of the structured supervised programme<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lifestyle and medical risk factor modification | Achieving target Improvement in lifestyle risk factors. Target improvement will be considered if the patient achieves any one or more of the following: Smoking cessation Body mass index 20-25 (kg/m^2). BMI is calculated by dividing body weight in kilograms by the square of height in meters Glycosylated haemoglobin (HbA1c) less than 7% Total Cholesterol less than 5.0 mmol/L | at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation free survival | if the patient underwent a major amputation and level of amputation | 1 year | 
| Re-intervention or stenosis rate | Any re-intervention or stenosis among patients who already underwent vascular surgery | 1 year | 
| Freedom from major adverse cardiovascular events (MACE) and major adverse limb events (MALE) | If the patient developed a major adverse cardiovascular event (MACE) or major adverse limb event (MALE) | 1 year | 
| Revascularisation-free survival | if the patient underwent any revascularisation procedure | 1 year | 
| Health related quality of life | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral arterial disease, Risk factor modifications, Cardiovascular risk factors