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Physical activity intervention for elderly patients with reduced physical performance after acute coronary syndrome (HULK study): rationale and design of a randomized clinical trial.

ABSTRACT: BACKGROUND:Reduced physical performance and impaired mobility are common in elderly patients after acute coronary syndrome (ACS) and they represent independent risk factors for disability, morbidity, hospital readmission and mortality. Regular physical exercise represents a means for improving functional capacity. Nevertheless, its clinical benefit has been less investigated in elderly patients in the early phase after ACS. The HULK trial aims to investigate the clinical benefit of an early, tailored low-cost physical activity intervention in comparison to standard of care in elderly ACS patients with reduced physical performance. DESIGN:HULK is an investigator-initiated, prospective multicenter randomized controlled trial (NCT03021044). After successful management of the ACS acute phase and uneventful first 1 month, elderly (?70 years) patients showing reduced physical performance are randomized (1:1 ratio) to either standard of care or physical activity intervention. Reduced physical performance is defined as a short physical performance battery (SPPB) score of 4-9. The early, tailored, low-cost physical intervention includes 4 sessions of physical activity with a supervisor and an home-based program of physical exercise. The chosen primary endpoint is the 6-month SPPB value. Secondary endpoints briefly include quality of life, on-treatment platelet reactivity, some laboratory data and clinical adverse events. To demonstrate an increase of at least one SPPB point in the experimental arm, a sample size of 226 patients is needed. CONCLUSIONS:The HULK study will test the hypothesis that an early, tailored low-cost physical activity intervention improves physical performance, quality of life, frailty status and outcome in elderly ACS patients with reduced physical performance. TRIAL REGISTRATION:Clinicaltrials.gov, identifier NCT03021044 , first posted January, 13th 2017.

SUBMITTER: Tonet E

PROVIDER: S-EPMC5963011 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Physical activity intervention for elderly patients with reduced physical performance after acute coronary syndrome (HULK study): rationale and design of a randomized clinical trial.

Tonet Elisabetta E Maietti Elisa E Chiaranda Giorgio G Vitali Francesco F Serenelli Matteo M Bugani Giulia G Mazzoni Gianni G Ruggiero Rossella R Myers Jonathan J Villani Giovanni Quinto GQ Corvi Ursula U Pasanisi Giovanni G Biscaglia Simone S Pavasini Rita R Lucchi Giulia Ricci GR Sella Gianluigi G Ferrari Roberto R Volpato Stefano S Campo Gianluca G Grazzi Giovanni G

BMC cardiovascular disorders 20180521 1

<h4>Background</h4>Reduced physical performance and impaired mobility are common in elderly patients after acute coronary syndrome (ACS) and they represent independent risk factors for disability, morbidity, hospital readmission and mortality. Regular physical exercise represents a means for improving functional capacity. Nevertheless, its clinical benefit has been less investigated in elderly patients in the early phase after ACS. The HULK trial aims to investigate the clinical benefit of an ea ...[more]

PMID: 29783928

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Project description:BackgroundPositive psychological constructs, such as optimism, are associated with greater participation in cardiac health behaviors and improved cardiac outcomes. Positive psychology interventions, which target psychological well-being, may represent a promising approach to improving health behaviors in high-risk cardiac patients. However, no study has assessed whether a positive psychology intervention can promote physical activity following an acute coronary syndrome.ObjectiveIn this article we will describe the methods of a novel factorial design study to aid the development of a positive psychology-based intervention for acute coronary syndrome patients and aim to provide preliminary feasibility data on study implementation.MethodsThe Positive Emotions after Acute Coronary Events III study is an optimization study (planned N = 128), subsumed within a larger multiphase optimization strategy iterative treatment development project. The goal of Positive Emotions after Acute Coronary Events III is to identify the ideal components of a positive psychology-based intervention to improve post-acute coronary syndrome physical activity. Using a 2 × 2 × 2 factorial design, Positive Emotions after Acute Coronary Events III aims to: (1) evaluate the relative merits of using positive psychology exercises alone or combined with motivational interviewing, (2) assess whether weekly or daily positive psychology exercise completion is optimal, and (3) determine the utility of booster sessions. The study's primary outcome measure is moderate-to-vigorous physical activity at 16 weeks, measured via accelerometer. Secondary outcome measures include psychological, functional, and adherence-related behavioral outcomes, along with metrics of feasibility and acceptability. For the primary study outcome, we will use a mixed-effects model with a random intercept (to account for repeated measures) to assess the main effects of each component (inclusion of motivational interviewing in the exercises, duration of the intervention, and inclusion of booster sessions) from a full factorial model controlling for baseline activity. Similar analyses will be performed on self-report measures and objectively-measured medication adherence over 16 weeks. We hypothesize that the combined positive psychology and motivational interviewing intervention, weekly exercises, and booster sessions will be associated with superior physical activity.ResultsThus far, 78 participants have enrolled, with 72% of all possible exercises fully completed by participants.ConclusionThe Positive Emotions after Acute Coronary Events III study will help to determine the optimal content, intensity, and duration of a positive psychology intervention in post-acute coronary syndrome patients prior to testing in a randomized trial. This study is novel in its use of a factorial design within the multiphase optimization strategy framework to optimize a behavioral intervention and the use of a positive psychology intervention to promote physical activity in high-risk cardiac patients.

Project description:Background and Objectives: Nearly 23% of elderly patients hospitalized due to acute coronary syndrome have reduced muscle strength. It is assumed that these patients would better benefit from a complex training-a combination of endurance, strength, balance, coordination, and flexibility-in order to reduce the loss of muscle strength and mass and improve functional capacity. The aim of this study was to assess the effectiveness and safety of two different complementary resistance and balance training programs during short-term cardiac rehabilitation (CR) in elderly patients after a percutaneous or surgical intervention due to acute coronary syndrome. Materials and Methods: This randomized controlled trial was conducted from January 2020 to February 2021 in one Lithuanian rehabilitation hospital. A total of 63 participants who met the inclusion criteria were randomly assigned to three groups (at the ratio of 1:1:1): control (CG, n = 19), intervention 1 (IG-1, n = 26), and intervention 2 (IG-2, n = 18). All the patients attended a usual inpatient CR program of a mean duration of 18.7 ± 1.7 days, while the patients assigned to the intervention groups (IG-1 and IG-2) additionally received different resistance and balance training programs three days a week. Functional capacity, with 6-minute walk test (6MWT) and cardiopulmonary exercise testing (CPET), as well as physical performance, with the short physical performance battery (SPPB) test and one repetition maximum test (1RM) for leg press, were assessed at baseline and after CR. Results: The mean age of the participants was 72.9 ± 5.5 years; 73% were men. All parameters of functional capacity and physical performance improved significantly after CR (p < 0.05), except for peak VO2 that improved only in the IG-1. Comparison of CR effectiveness among the groups revealed no significant differences. Conclusions: All three rehabilitation programs were safe and well tolerated by elderly patients aged ≥65 years as well as improved functional capacity (6-minute walk distance and peak workload) and physical performance (SPPB and 1RM). Complementary resistance and balance training with traditional physical therapy means and exercises with mechanical devices did not show greater benefits for the results of physical performance compared with the usual CR program.

Project description:IntroductionHigh residual platelet reactivity (RPR) in patients after percutaneous coronary intervention (PCI) receiving antiplatelet agents has been associated with a high risk of developing acute kidney injury (AKI).Study aimThis study aimed at identification of independent prognostic predictors of AKI risk in patients with acute coronary syndrome (ACS) after PCI.Study design, setting and patientsThis was a prospective single-center clinical trial that included 155 patients (n = 119 without AKI, n = 36 with AKI, mean age 64.0±10.6 years, of whom 74.2% were males), who underwent PCI with stenting. We prospectively evaluated RPR using optical aggregometry. Development of AKI was the primary endpoint.ResultsAcute renal dysfunction was observed in 36 patients (23.2%) after PCI, the risk factors of which according to univariate regression analysis were: age (p = 0.040), low diastolic blood pressure (DBP) (p = 0.001), having severe heart failure (HF) according to Killip (p<0.001), low level of hemoglobin (p = 0.026) and erythrocytes (p = 0.005), increased creatinine (p<0.001), low baseline glomerular filtration rate (GFR) (p<0.001), low left ventricular ejection fraction (LV EF) (p = 0.003), high residual platelet reactivity (RPR) (p<0.001) and platelet aggregation area under the curve (AUC) with 10 ?g/mL ADP (p<0.001), as well as dose of X-ray contrast medium (XCM) (p = 0.008). As a result of multivariate regression analysis the following independent predictors of AKI were established with the inclusion of the above factors: baseline creatinine level [OR 1.033 at 95% CI from 1.017 to 1.049; p<0.001], RPR with 10 ?g/mL ADP [OR 1.060 at 95% CI from 1.027 to 1.094; p = 0.001], dose of an XCM [?R 1.005 at 95% CI from 1.001 to 1.008; ? = 0.014], diastolic blood pressure (DBP) [OR 0.926 at 95% CI from 0.888 to 0.965; p<0.001].ConclusionADP-induced high residual platelet reactivity, baseline creatinine level, X-ray contrast medium, low diastolic blood pressure were independent predictors of AKI in patients with ACS after PCI.

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Physical activity intervention for elderly patients with reduced physical performance after acute coronary syndrome (HULK study): rationale and design of a randomized clinical trial.

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Physical activity intervention for elderly patients with reduced physical performance after acute coronary syndrome (HULK study): rationale and design of a randomized clinical trial.

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