Lifestyle Modification Programme for Patients With Peripheral Arterial Disease

Western Vascular Institute, Ireland

Status: Unknown

Conditions: Peripheral Arterial Occlusive Disease

Treatments: Behavioral: Risk Factors Modification Programme; Behavioral: Standard Healthcare

Study type: Interventional

Funder types: Other

Identifiers

NCT03935776

WVI-PAD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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208 participants in 2 patient groups

Risk Factors Modification Programme

Experimental group

Description:

* 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.

Treatment:

Behavioral: Risk Factors Modification Programme

Standard Healthcare

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Healthcare