Lifestyle Modification Programme for Patients With Peripheral Arterial Disease
NCT ID: NCT03935776
Last Updated: 2021-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
208 participants
INTERVENTIONAL
2018-06-01
2022-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients
NCT05961943
Lifestyle Heart Trial
NCT00000471
Reducing Risk Factors in Peripheral Arterial Disease
NCT00217919
Multifactorial Intervention on Cardiovascular Risk Factors in Subjects With Peripheral Arterial Disease
NCT00144937
Motivational Interviewing (MI) for African Americans With Peripheral Arterial Disease (PAD)
NCT01321086
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Risk Factors Modification Programme
12- week supervised risk factor modification programme derived from the Euroaction study standards
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.
Standard Healthcare
Patients are advised to adjust lifestyle without the support of the structured supervised programme
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Risk Factors Modification Programme
12- week supervised risk factor modification programme derived from the Euroaction study standards
Standard Healthcare
Patients are advised to adjust lifestyle without the support of the structured supervised programme
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Western Vascular Institute, Ireland
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wael Tawfick, MB BcH,MRCSI
Role: PRINCIPAL_INVESTIGATOR
Western Vascular Institute, Ireland
Sherif Sultan, MB BcH,MRCSI
Role: PRINCIPAL_INVESTIGATOR
Western Vascular Institute, Ireland
Marah Elfghi, MB BcH, MSc
Role: STUDY_DIRECTOR
Western Vascular Institute, Ireland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital
Galway, , Ireland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WVI-PAD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.