Clinical trial NCT03935776: Lifestyle Modification Programme for Patients With Peripheral Arterial Disease
Official title: The Effect of Lifestyle and Risk Factor Modification on Occlusive Peripheral Arterial Disease Outcomes: Standard Healthcare vs Structured Programme
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Occlusive Disease
Keywords: Peripheral arterial disease
Risk factor modifications
Cardiovascular risk factors
Lead sponsor: Western Vascular Institute, Ireland
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomised, parallel group, active-control trial, with patients randomised in a 1:1 ratio
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lifestyle and medical risk factor modification
timeFrame: at 12 weeks
Secondary outcomes:
measure: Amputation free survival
timeFrame: 1 year
measure: Re-intervention or stenosis rate
timeFrame: 1 year
measure: Freedom from major adverse cardiovascular events (MACE) and major adverse limb events (MALE)
timeFrame: 1 year
measure: Revascularisation-free survival
timeFrame: 1 year
measure: Health related quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital
Study officials:
affiliation: Western Vascular Institute, Ireland
name: Wael Tawfick, MB BcH,MRCSI
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Vascular Institute, Ireland
name: Sherif Sultan, MB BcH,MRCSI
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Vascular Institute, Ireland
name: Marah Elfghi, MB BcH, MSc
role: STUDY_DIRECTOR
References:
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