NCT03935776

Lifestyle Modification Programme for Patients With Peripheral Arterial Disease

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: Western Vascular Institute, Ireland · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Occlusive Disease

Interventions

Type	Name	Description
BEHAVIORAL	Risk Factors Modification Programme	12- week supervised risk factor modification programme derived from the Euroaction study standards
BEHAVIORAL	Standard Healthcare	Patients are advised to adjust lifestyle without the support of the structured supervised programme

Timeline

• Start date: 2018-06-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2019-05-02
• Last updated: 2021-08-04

Locations

1 site across 1 country: Ireland