Lifestyle Modification Programme for Patients With Peripheral Arterial Disease

NCT03935776 | Unknown

• 1 other identifier: WVI-PAD
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Occlusive Disease

Keywords

Peripheral arterial disease; Risk factor modifications; Cardiovascular risk factors

Outcome Measures

Primary Outcomes (1)

• 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: 1. Smoking cessation 2. Body mass index 20-25 (kg/m\^2). BMI is calculated by dividing body weight in kilograms by the square of height in meters 3. Glycosylated haemoglobin (HbA1c) less than 7% 4. Total Cholesterol less than 5.0 mmol/L

  at 12 weeks

Secondary Outcomes (5)

• Amputation free survival

  1 year

• Re-intervention or stenosis rate

  1 year

• Freedom from major adverse cardiovascular events (MACE) and major adverse limb events (MALE)

  1 year

• Revascularisation-free survival

  1 year

• Health related quality of life

  1 year

Study Arms (2)

Risk Factors Modification Programme

EXPERIMENTAL

* 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

Standard Healthcare

ACTIVE COMPARATOR

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

Interventions

Risk Factors Modification Programme BEHAVIORAL

12- week supervised risk factor modification programme derived from the Euroaction study standards

Risk Factors Modification Programme

Standard Healthcare BEHAVIORAL

Patients are advised to adjust lifestyle without the support of the structured supervised programme

Standard Healthcare

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western Vascular Institute, Ireland: lead

Study Sites (1)

Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital

Galway, Ireland

RECRUITING

Related Publications (12)

• 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.

  PMID: 23915883 BACKGROUND

• 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.

  PMID: 10073955 BACKGROUND

• 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.

  PMID: 11560536 BACKGROUND

• 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.

  PMID: 11788688 BACKGROUND

• 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.

  PMID: 3156007 BACKGROUND

• 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.

  PMID: 16549646 BACKGROUND

• 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.

  PMID: 17223489 BACKGROUND

• 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.

  PMID: 26876071 BACKGROUND

• Lu JT, Creager MA. The relationship of cigarette smoking to peripheral arterial disease. Rev Cardiovasc Med. 2004 Fall;5(4):189-93.

  PMID: 15580157 BACKGROUND

• 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.

  PMID: 26763263 BACKGROUND

• 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.

  PMID: 9308598 BACKGROUND

• 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.

  PMID: 33581715 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Wael Tawfick, MB BcH,MRCSI

  Western Vascular Institute, Ireland

  PRINCIPAL INVESTIGATOR

• Sherif Sultan, MB BcH,MRCSI

  Western Vascular Institute, Ireland

  PRINCIPAL INVESTIGATOR

• Marah Elfghi, MB BcH, MSc

  Western Vascular Institute, Ireland

  STUDY DIRECTOR

Central Study Contacts

Wael Tawfick, MB BcH,MRCSI

CONTACT

+ 35391542535; wael.tawfick@hse.ie

Sherif Sultan, MD, FRCSI

CONTACT

+35391542534; sherif.sultan@hse.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomised, parallel group, active-control trial, with patients randomised in a 1:1 ratio

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: May 2, 2019
• Study Start: June 1, 2018
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 4, 2021

Record last verified: 2021-08

Locations

IE (1)