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Lifestyle Modification Programme for Patients With Peripheral Arterial Disease
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Peripheral Arterial Occlusive Disease | Behavioral: Risk Factors Modification Programme Behavioral: Standard Healthcare | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 208 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This is a randomised, parallel group, active-control trial, with patients randomised in a 1:1 ratio |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Masking Description: | Blinding of trial participants and care providers is not possible because of obvious differences between the interventions. However, the investigator, the outcomes assessor and statistician are blinded to treatment received. |
| Primary Purpose: | Treatment |
| Official Title: | The Effect of Lifestyle and Risk Factor Modification on Occlusive Peripheral Arterial Disease Outcomes: Standard Healthcare vs Structured Programme |
| Actual Study Start Date : | June 1, 2018 |
| Estimated Primary Completion Date : | September 1, 2020 |
| Estimated Study Completion Date : | June 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
Experimental: Risk Factors Modification Programme
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Behavioral: Risk Factors Modification Programme
12- week supervised risk factor modification programme derived from the Euroaction study standards
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Active Comparator: Standard Healthcare
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.
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Behavioral: Standard Healthcare
Patients are advised to adjust lifestyle without the support of the structured supervised programme
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- Lifestyle and medical risk factor modification [ Time Frame: at 12 weeks ]
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
- Amputation free survival [ Time Frame: 1 year ]if the patient underwent a major amputation and level of amputation
- Re-intervention or stenosis rate [ Time Frame: 1 year ]Any re-intervention or stenosis among patients who already underwent vascular surgery
- Freedom from major adverse cardiovascular events (MACE) and major adverse limb events (MALE) [ Time Frame: 1 year ]If the patient developed a major adverse cardiovascular event (MACE) or major adverse limb event (MALE)
- Revascularisation-free survival [ Time Frame: 1 year ]if the patient underwent any revascularisation procedure
- Health related quality of life [ Time Frame: 1 year ]
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.
| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Aged 18 years or more
- Provide written informed consent
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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.
| Contact: Wael Tawfick, MB BcH,MRCSI | + 35391542535 | wael.tawfick@hse.ie | |
| Contact: Sherif Sultan, MD, FRCSI | +35391542534 | sherif.sultan@hse.ie |
| Ireland | |
| Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital | Recruiting |
| Galway, Ireland | |
| Contact: Sherif Sultan, MD +35391542534 sherif.sultan@hse.ie | |
| Contact: Wael Tawfick, MD +35391542535 wael.tawfick@hse.ie | |
| Principal Investigator: | Wael Tawfick, MB BcH,MRCSI | Western Vascular Institute, Ireland | |
| Principal Investigator: | Sherif Sultan, MB BcH,MRCSI | Western Vascular Institute, Ireland | |
| Study Director: | Marah Elfghi, MB BcH, MSc | Western Vascular Institute, Ireland |
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | February 15, 2019 | |||||||||
| First Posted Date ICMJE | May 2, 2019 | |||||||||
| Last Update Posted Date | May 2, 2019 | |||||||||
| Actual Study Start Date ICMJE | June 1, 2018 | |||||||||
| Estimated Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Lifestyle and medical risk factor modification [ Time Frame: at 12 weeks ] Achieving target Improvement in lifestyle risk factors. Target improvement will be considered if the patient achieves any one or more of the following:
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Lifestyle Modification Programme for Patients With Peripheral Arterial Disease | |||||||||
| Official Title ICMJE | The Effect of Lifestyle and Risk Factor Modification on Occlusive Peripheral Arterial Disease Outcomes: Standard Healthcare vs Structured Programme | |||||||||
| 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. |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: This is a randomised, parallel group, active-control trial, with patients randomised in a 1:1 ratio Masking: Double (Investigator, Outcomes Assessor)Masking Description: Blinding of trial participants and care providers is not possible because of obvious differences between the interventions. However, the investigator, the outcomes assessor and statistician are blinded to treatment received. Primary Purpose: Treatment
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| Condition ICMJE | Peripheral Arterial Occlusive Disease | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Unknown status | |||||||||
| Estimated Enrollment ICMJE |
208 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | June 1, 2021 | |||||||||
| Estimated Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 100 Years (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Ireland | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT03935776 | |||||||||
| Other Study ID Numbers ICMJE | WVI-PAD | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Western Vascular Institute, Ireland | |||||||||
| Study Sponsor ICMJE | Western Vascular Institute, Ireland | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Western Vascular Institute, Ireland | |||||||||
| Verification Date | April 2019 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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