Lifestyle Modification Programme for Patients With Peripheral Arterial Disease

  • STATUS
    Recruiting
  • days left to enroll
    22
  • participants needed
    208
  • sponsor
    Western Vascular Institute, Ireland
Updated on 5 February 2022
arteriopathy
angiography
peripheral vascular disease
hba1c
total cholesterol
tobacco in any form
exposure to tobacco

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.

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.

Details
Condition Peripheral Arterial Occlusive Disease
Treatment Risk Factors Modification Programme, Standard Healthcare
Clinical Study IdentifierNCT03935776
SponsorWestern Vascular Institute, Ireland
Last Modified on5 February 2022

Eligibility

Yes No Not Sure

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 -human chorionic gonadotropion (HCG) analysis)
Contraindication to anticoagulation and antiplatelet medications or any of the risk factors treatment
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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