دورية أكاديمية
Multi-domain lifestyle intervention in older adults after myocardial infarction: rationale and design of the PIpELINe randomized clinical trial.
| العنوان: | Multi-domain lifestyle intervention in older adults after myocardial infarction: rationale and design of the PIpELINe randomized clinical trial. |
|---|---|
| المؤلفون: | Tonet E; Cardiovascular Institute, Azienda Ospedaliera Universitaria di Ferrara, Cona, FE, Italy., Raisi A; Center for Sports and Exercise Science, Department of Neuroscience and Rehabilitation, University of Ferrara, Ferrara, Italy., Zagnoni S; Cardiology Unit, Ospedale Maggiore, Azienda USL Bologna, Bologna, Italy., Chiaranda G; Sports Medicine and Health Promotion Unit, Azienda Unità Sanitaria locale di Piacenza, Piacenza, Italy., Pavasini R; Cardiovascular Institute, Azienda Ospedaliera Universitaria di Ferrara, Cona, FE, Italy., Vitali F; Cardiovascular Institute, Azienda Ospedaliera Universitaria di Ferrara, Cona, FE, Italy., Gibiino F; Cardiovascular Institute, Azienda Ospedaliera Universitaria di Ferrara, Cona, FE, Italy., Campana R; Cardiovascular Institute, Azienda Ospedaliera Universitaria di Ferrara, Cona, FE, Italy., Boccadoro A; Cardiovascular Institute, Azienda Ospedaliera Universitaria di Ferrara, Cona, FE, Italy., Scala A; Cardiovascular Institute, Azienda Ospedaliera Universitaria di Ferrara, Cona, FE, Italy., Canovi L; Cardiovascular Institute, Azienda Ospedaliera Universitaria di Ferrara, Cona, FE, Italy., Amantea V; Cardiovascular Institute, Azienda Ospedaliera Universitaria di Ferrara, Cona, FE, Italy., Matese C; Cardiovascular Institute, Azienda Ospedaliera Universitaria di Ferrara, Cona, FE, Italy., Berloni ML; Cardiovascular Institute, Azienda Ospedaliera Universitaria di Ferrara, Cona, FE, Italy., Piva T; Center for Sports and Exercise Science, Department of Neuroscience and Rehabilitation, University of Ferrara, Ferrara, Italy., Zerbini V; Center for Sports and Exercise Science, Department of Neuroscience and Rehabilitation, University of Ferrara, Ferrara, Italy., Cardelli LS; Cardiology Unit, Ospedale Maggiore, Azienda USL Bologna, Bologna, Italy., Pasanisi G; Rehabilitation Cardiology, Azienda USL di Ferrara, Lagosanto, FE, Italy., Mazzoni G; Center for Sports and Exercise Science, Department of Neuroscience and Rehabilitation, University of Ferrara, Ferrara, Italy., Casella G; Cardiology Unit, Ospedale Maggiore, Azienda USL Bologna, Bologna, Italy., Grazzi G; Center for Sports and Exercise Science, Department of Neuroscience and Rehabilitation, University of Ferrara, Ferrara, Italy.; Healthy Living for Pandemic Event Protection (HL-PIVOT) Network, Chicago, IL, USA., Campo G; Cardiovascular Institute, Azienda Ospedaliera Universitaria di Ferrara, Cona, FE, Italy. cmpglc@unife.it. |
| المصدر: | Aging clinical and experimental research [Aging Clin Exp Res] 2023 May; Vol. 35 (5), pp. 1107-1115. Date of Electronic Publication: 2023 Mar 25. |
| نوع المنشور: | Randomized Controlled Trial; Multicenter Study; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Springer Country of Publication: Germany NLM ID: 101132995 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1720-8319 (Electronic) Linking ISSN: 15940667 NLM ISO Abbreviation: Aging Clin Exp Res Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2013-> : Berlin : Springer Original Publication: Milano, Italy : Editrice Kurtis, c2002- |
| مواضيع طبية MeSH: | Myocardial Infarction*/therapy , Cardiac Rehabilitation*, Aged ; Humans ; Prospective Studies ; Life Style ; Exercise |
| مستخلص: | Background: Traditional cardiac rehabilitation (CR) is effective in improving physical performance and prognosis after myocardial infarction (MI). Anyway, it is not consistently recommended to older adults, and its attendance rate is low. Previous studies suggested that alternative, early and tailored exercise interventions are feasible and effective in improving physical performance in older MI patients. Anyway, the demonstration that they are associated also with a significant reduction of hard endpoints is lacking. Aim: To describe rationale and design of the "Physical activity Intervention in Elderly patients with myocardial Infarction" (PIpELINe) trial. Methods: The PIpELINe trial is a prospective, randomized, multicentre study with a blinded adjudicated evaluation of the outcomes. Patients aged ≥ 65 years, admitted to hospital for MI and with a low physical performance one month after discharge, as defined as short physical performance battery (SPPB) value between 4 and 9, will be randomized to a multi-domain lifestyle intervention (including dietary counselling, strict management of cardiovascular and metabolic risk factors, and exercise training) or health education. The primary endpoint is the one-year occurrence of the composite of cardiovascular death or re-hospitalization for cardiovascular causes. Results: The recruitment started in March 2020. The estimated sample size is 456 patients. The conclusion of the enrolment is planned for mid-2023. The primary endpoint analysis will be available for the end of 2024. Conclusions: The PIpELINe trial will show if a multi-domain lifestyle intervention is able to reduce adverse events in older patients with reduced physical performance after hospitalization for MI. Trial Registration: ClinicalTrials.gov NCT04183465. (© 2023. The Author(s).) |
| References: | Visseren FLJ, Mach F, Smulders YM et al (2022) ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur J Prev Cardiol 29:5–115. (PMID: 10.1093/eurjpc/zwab15434558602) Campo G, Maietti E, Tonet E et al (2020) The assessment of scales of frailty and physical performance improves prediction of major adverse cardiac events in older adults with acute coronary syndrome. J Gerontol A Biol Sci Med Sci 75:1113–1119. (PMID: 10.1093/gerona/glz12331075167) van Jaarsveld CH, Sanderman R, Miedema I et al (2001) Changes in health-related quality of life in older patients with acute myocardial infarction or congestive heart failure: a prospective study. J Am Geriatr Soc 49:1052–1058. (PMID: 10.1046/j.1532-5415.2001.49208.x11555066) Biscaglia S, Campo G, Sorbets E et al (2020) Relationship between physical activity and long-term outcomes in patients with stable coronary artery disease. Eur J Prev Cardiol 27:426–436. (PMID: 10.1177/204748731987121731558054) Ekblom O, Ek A, Cider Å et al (2018) Increased physical activity post-myocardial infarction is related to reduced mortality: results from the SWEDEHEART registry. J Am Heart Assoc 7:e010108. (PMID: 10.1161/JAHA.118.010108305612636405601) Lehtisalo J, Rusanen M, Solomon A et al (2022) Effect of a multi-domain lifestyle intervention on cardiovascular risk in older people: the FINGER trial. Eur Heart J 43:2054–2061. (PMID: 10.1093/eurheartj/ehab922350512819156384) Huang R, Palmer SC, Cao Y et al (2021) Cardiac rehabilitation programs for chronic heart disease: a Bayesian network meta-analysis. Can J Cardiol 37:162–171. (PMID: 10.1016/j.cjca.2020.02.07232485140) Pardaens S, Willems AM, Clays E et al (2017) The impact of drop-out in cardiac rehabilitation on outcome among coronary artery disease patients. Eur J Prev Cardiol 24:1490–1497. (PMID: 10.1177/204748731772457428758419) Collins ZC, Suskin N, Aggarwal S et al (2015) Cardiac rehabilitation wait times and relation to patient outcomes. Eur J Phys Rehabil Med 5:301–309. Pack QR, Mansour M, Barboza JS et al (2013) An early appointment to outpatient cardiac rehabilitation at hospital discharge improves attendance at orientation: a randomized, single-blind, controlled trial. Circulation 127:349–355. (PMID: 10.1161/CIRCULATIONAHA.112.12199623250992) Brovold T, Skelton DA, Bergland A (2013) Older adults recently discharged from the hospital: effect of aerobic interval exercise on health-related quality of life, physical fitness, and physical activity. J Am Geriatr Soc 61:1580–1585. (PMID: 10.1111/jgs.1240023927819) Tonet E, Maietti E, Chiaranda G et al (2018) Physical activity intervention for elderly patients with reduced physical performance after acute coronary syndrome (HULK study): rationale and design of a randomized clinical trial. BMC Cardiovasc Disord 18:98. (PMID: 10.1186/s12872-018-0839-8297839285963011) Campo G, Tonet E, Chiaranda G et al (2019) Exercise intervention to improve functional capacity in older adults after acute coronary syndrome. J Am Coll Cardiol 74:2948–2950. (PMID: 10.1016/j.jacc.2019.10.01031806139) Campo G, Tonet E, Chiaranda G et al (2020) Exercise intervention improves quality of life in older adults after myocardial infarction: randomised clinical trial. Heart 106:1658–1664. (PMID: 10.1136/heartjnl-2019-31634932144189) Thygesen K, Alpert JS, Jaffe AS et al (2018) Fourth universal definition of myocardial infarction. Circulation 138:e618–e651. (PMID: 10.1161/CIR.000000000000061730571511) Martínez-González MA, Salas-Salvadó J, Estruch R et al (2015) Benefits of the Mediterranean diet: insights from the PREDIMED study. Prog Cardiovasc Dis 58:50–60. (PMID: 10.1016/j.pcad.2015.04.00325940230) Krumholz HM, Cohen BJ, Tsevat J et al (1993) Cost-effectiveness of a smoking cessation program after myocardial infarction. J Am Coll Cardiol 22:1697–1702. (PMID: 10.1016/0735-1097(93)90598-U8227841) Pavasini R, Tebaldi M, Bugani G et al (2021) Contrast associated acute kidney injury and mortality in older adults with acute coronary syndrome: a pooled analysis of the FRASER and HULK studies. J Clin Med 10:2151. (PMID: 10.3390/jcm10102151340656428156026) Völz S, Petursson P, Angerås O et al (2020) Prognostic impact of percutaneous coronary intervention in octogenarians with non-ST elevation myocardial infarction: a report from SWEDEHEART. Eur Heart J Acute Cardiovasc Care 9:480–487. (PMID: 10.1177/204887261987728731517503) Campo G, Fortuna D, Berti E et al (2021) In- and out-of-hospital mortality for myocardial infarction during the first wave of the COVID-19 pandemic in Emilia-Romagna, Italy: a population-based observational study. Lancet Reg Health Eur 3:100055. (PMID: 10.1016/j.lanepe.2021.100055345578008454529) Madhavan MV, Gersh BJ, Alexander KP et al (2018) Coronary artery disease in patients ≥80 years of age. J Am Coll Cardiol 71:2015–2040. (PMID: 10.1016/j.jacc.2017.12.06829724356) Marchionni N, Fattirolli F, Fumagalli S et al (2003) Improved exercise tolerance and quality of life with cardiac rehabilitation of older patients after myocardial infarction: results of a randomized, controlled trial. Circulation 107:2201–2206. (PMID: 10.1161/01.CIR.0000066322.21016.4A12707240) Prabhakaran D, Chandrasekaran AM, Singh K et al (2020) Yoga-based cardiac rehabilitation after acute myocardial infarction: a randomized trial. J Am Coll Cardiol 75:1551–1561. (PMID: 10.1016/j.jacc.2020.01.050322413717132532) Bush M, Kucharska-Newton A, Simpson RJ Jr et al (2020) Effect of initiating cardiac rehabilitation after myocardial infarction on subsequent hospitalization in older adults. J Cardiopulm Rehabil Prev 40:87–93. (PMID: 10.1097/HCR.0000000000000452315929307054180) Mazzoni G, Raisi A, Myers J et al (2022) Promotion and maintenance of physically active lifestyle in older outpatients 2 years after acute coronary syndrome. Aging Clin Exp Res 34:1065–1072. (PMID: 10.1007/s40520-021-02044-134997543) |
| معلومات مُعتمدة: | GR 2018-12367114 Ministero della Salute |
| فهرسة مساهمة: | Keywords: Exercise intervention; Lifestyle intervention; Myocardial infarction; Older patients |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04183465 |
| تواريخ الأحداث: | Date Created: 20230325 Date Completed: 20230502 Latest Revision: 20230502 |
| رمز التحديث: | 20230502 |
| مُعرف محوري في PubMed: | PMC10039445 |
| DOI: | 10.1007/s40520-023-02389-9 |
| PMID: | 36964866 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 1720-8319 |
|---|---|
| DOI: | 10.1007/s40520-023-02389-9 |