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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Occlusive Disease
• Intervention / Treatment: Behavioral: Risk Factors Modification Programme; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Galway, Ireland
    • Recruiting
    • Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Risk Factors Modification Programme; 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.	Behavioral: Risk Factors Modification Programme; 12- week supervised risk factor modification programme derived from the Euroaction study standards
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.	Behavioral: Standard Healthcare; Patients are advised to adjust lifestyle without the support of the structured supervised programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lifestyle and medical risk factor modification	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	at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amputation free survival	if the patient underwent a major amputation and level of amputation	1 year
Re-intervention or stenosis rate	Any re-intervention or stenosis among patients who already underwent vascular surgery	1 year
Freedom from major adverse cardiovascular events (MACE) and major adverse limb events (MALE)	If the patient developed a major adverse cardiovascular event (MACE) or major adverse limb event (MALE)	1 year
Revascularisation-free survival	if the patient underwent any revascularisation procedure	1 year
Health related quality of life	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.	1 year

Collaborators and Investigators

• Sponsor: Western Vascular Institute, Ireland
• Investigators: Principal Investigator: Sherif Sultan, MB BcH,MRCSI, Western Vascular Institute, Ireland; Study Director: Marah Elfghi, MB BcH, MSc, Western Vascular Institute, Ireland

Publications and helpful links

General Publications

• Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4. Erratum In: J Vasc Surg 2001 Apr;33(4):805.
• Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.
• Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.
• Newman AB, Shemanski L, Manolio TA, Cushman M, Mittelmark M, Polak JF, Powe NR, Siscovick D. Ankle-arm index as a predictor of cardiovascular disease and mortality in the Cardiovascular Health Study. The Cardiovascular Health Study Group. Arterioscler Thromb Vasc Biol. 1999 Mar;19(3):538-45. doi: 10.1161/01.atv.19.3.538.
• Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. doi: 10.1001/jama.286.11.1317.
• Becker GJ, McClenny TE, Kovacs ME, Raabe RD, Katzen BT. The importance of increasing public and physician awareness of peripheral arterial disease. J Vasc Interv Radiol. 2002 Jan;13(1):7-11. doi: 10.1016/s1051-0443(07)60002-5. No abstract available.
• Criqui MH, Fronek A, Klauber MR, Barrett-Connor E, Gabriel S. The sensitivity, specificity, and predictive value of traditional clinical evaluation of peripheral arterial disease: results from noninvasive testing in a defined population. Circulation. 1985 Mar;71(3):516-22. doi: 10.1161/01.cir.71.3.516.
• Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007 Jan;45 Suppl S:S5-67. doi: 10.1016/j.jvs.2006.12.037. No abstract available.
• Shen C, Li W. [Interpretation and consideration of the Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities management of asymptomatic disease and claudication]. Zhonghua Wai Ke Za Zhi. 2016 Feb 1;54(2):81-3. doi: 10.3760/cma.j.issn.0529-5815.2016.02.001. Chinese.
• Lu JT, Creager MA. The relationship of cigarette smoking to peripheral arterial disease. Rev Cardiovasc Med. 2004 Fall;5(4):189-93.
• Mahe G, Kaladji A, Le Faucheur A, Jaquinandi V. Internal Iliac Artery Disease Management: Still Absent in the Update to TASC II (Inter-Society Consensus for the Management of Peripheral Arterial Disease). J Endovasc Ther. 2016 Feb;23(1):233-4. doi: 10.1177/1526602815621757. No abstract available.
• Elfghi M, Jordan F, Dunne D, Gibson I, Jones J, Flaherty G, Sultan S, Tawfick W. The effect of lifestyle and risk factor modification on occlusive peripheral arterial disease outcomes: standard healthcare vs structured programme-for a randomised controlled trial protocol. Trials. 2021 Feb 13;22(1):138. doi: 10.1186/s13063-021-05087-x.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (ACTUAL): May 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Peripheral arterial disease; Cardiovascular risk factors; Risk factor modifications
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: WVI-PAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual patient data of primary and secondary outcomes, could be made available to other researchers by request, while maintaining participant confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No