The frailty in elderly patients receiving cardiac interventional procedures (FRASER) program: rational and design of a multicenter prospective study

Campo, Gianluca; Pavasini, Rita; Maietti, Elisa; Tonet, Elisabetta; Cimaglia, Paolo; Scillitani, Giulia; Bugani, Giulia; Serenelli, Matteo; Zaraket, Fátima; Balla, Cristina; Trevisan, Filippo; Biscaglia, Simone; Sassone, Biagio; Galvani, Marcello; Ferrari, Roberto; Volpato, Stefano

doi:10.1007/s40520-016-0662-y

Cited by 19 publications

(37 citation statements)

References 39 publications

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“…Taking into account previous studies and preliminary findings from the FRASER program [ 11 , 16 ], we expect to find in the experimental arm an increase of at least one point in the 6-month SPPB score, as compared to standard of care. Assuming a standard deviation of the SPPB score of 2.5, in order to obtain a statistical power ≥ 80% (alpha 5%), we would require an overall sample size of 226 patients.…”

Section: Methodsmentioning

confidence: 83%

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

Maietti

Chiaranda

et al. 2018

BMC Cardiovasc Disord

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BackgroundReduced 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.DesignHULK 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.ConclusionsThe 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 registrationClinicaltrials.gov, identifier NCT03021044, first posted January, 13th 2017.Electronic supplementary materialThe online version of this article (10.1186/s12872-018-0839-8) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 83%

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

Maietti

Chiaranda

et al. 2018

BMC Cardiovasc Disord

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“…Despite the availability of several standardised measures of physical strength and mobility, only one item of these scores is related to an approximate description of the functional status (eg, severe impairment of mobility secondary to musculoskeletal or neurological dysfunction)27 without a specification of the kind of test to be used. The major drawback for the daily application of the scales assessing physical performance is that they tend to be too long and complex 28. They require a specific preparation and a dedicated staff and are time-consuming.…”

Section: Discussionmentioning

confidence: 99%

“…Thus, grip strength may be an optimal first choice in the attempt to introduce the assessment of physical performance in the clinical decision-making process of patients with cardiac disorders. Obviously, these speculations need confirmation and future randomised controlled clinical trials are clearly in demand 28. Grip strength is a well-characterised measure of weakness and poor muscle performance.…”

Section: Discussionmentioning

confidence: 99%

Grip strength predicts cardiac adverse events in patients with cardiac disorders: an individual patient pooled meta-analysis

Pavasini

Serenelli²,

Celis‐Morales

et al. 2018

Heart

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ObjectiveGrip strength is a well-characterised measure of weakness and of poor muscle performance, but there is a lack of consensus on its prognostic implications in terms of cardiac adverse events in patients with cardiac disorders.MethodsArticles were searched in PubMed, Cochrane Library, BioMed Central and EMBASE. The main inclusion criteria were patients with cardiac disorders (ischaemic heart disease, heart failure (HF), cardiomyopathies, valvulopathies, arrhythmias); evaluation of grip strength by handheld dynamometer; and relation between grip strength and outcomes. The endpoints of the study were cardiac death, all-cause mortality, hospital admission for HF, cerebrovascular accident (CVA) and myocardial infarction (MI). Data of interest were retrieved from the articles and after contact with authors, and then pooled in an individual patient meta-analysis. Univariate and multivariate logistic regression was performed to define predictors of outcomes.ResultsOverall, 23 480 patients were included from 7 studies. The mean age was 62.3±6.9 years and 70% were male. The mean follow-up was 2.82±1.7 years. After multivariate analysis grip strength (difference of 5 kg, 5× kg) emerged as an independent predictor of cardiac death (OR 0.84, 95% CI 0.79 to 0.89, p<0.0001), all-cause death (OR 0.87, 95% CI 0.85 to 0.89, p<0.0001) and hospital admission for HF (OR 0.88, 95% CI 0.84 to 0.92, p<0.0001). On the contrary, we did not find any relationship between grip strength and occurrence of MI or CVA.ConclusionIn patients with cardiac disorders, grip strength predicted cardiac death, all-cause death and hospital admission for HF.Trial registration numberCRD42015025280.

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“…The present analysis was carried out by using the data of the populations of two different studies. The first one was the “Frailty in Elderly Patients Receiving Cardiac Interventional Procedures” (FRASER) study (NCT02386124) [ 14 , 15 , 16 ]. In brief, this multicentre, observational, prospective study analysed the frailty status of 402 adults aged ≥ 70 years admitted to four Italian hospitals, with a diagnosis of ACS [ 14 , 15 , 16 ].…”

Section: Methodsmentioning

confidence: 99%

Contrast Associated Acute Kidney Injury and Mortality in Older Adults with Acute Coronary Syndrome: A Pooled Analysis of the FRASER and HULK Studies

Pavasini

Tebaldi

Bugani

et al. 2021

JCM

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Whether contrast-associated acute kidney injury (CA-AKI) is only a bystander or a risk factor for mortality in older patients undergoing percutaneous coronary intervention (PCI) is not well understood. Data from FRASER (NCT02386124) and HULK (NCT03021044) studies have been analysed. All patients enrolled underwent coronary angiography. The occurrence of CA-AKI was defined based on KDIGO criteria. The primary outcome of the study was to test the relation between CA-AKI and 3-month mortality. Overall, 870 older ACS adults were included in the analysis (mean age 78 ± 5 years; 28% females). CA-AKI occurred in 136 (16%) patients. At 3 months, 13 (9.6%) patients with CA-AKI died as compared with 13 (1.8%) without it (p < 0.001). At multivariable analysis, CA-AKI emerged as independent predictor of 3-month mortality (HR 3.51, 95%CI 1.05–7.01). After 3 months, renal function returned to the baseline value in 78 (63%) with CA-AKI. Those without recovered renal function (n = 45, 37%) showed an increased risk of mortality as compared to recovered renal function and no CA-AKI subgroups (HR 2.01, 95%CI 1.55–2.59, p = 0.009 and HR 2.71, 95%CI 1.45–5.89, p < 0.001, respectively). In conclusion, CA-AKI occurs in a not negligible portion of older MI patients undergoing invasive strategy and it is associated with short-term mortality.

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The frailty in elderly patients receiving cardiac interventional procedures (FRASER) program: rational and design of a multicenter prospective study

Cited by 19 publications

References 39 publications

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

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

Grip strength predicts cardiac adverse events in patients with cardiac disorders: an individual patient pooled meta-analysis

Contrast Associated Acute Kidney Injury and Mortality in Older Adults with Acute Coronary Syndrome: A Pooled Analysis of the FRASER and HULK Studies

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