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. 2018 May 21;18(1):98.
doi: 10.1186/s12872-018-0839-8.

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

Elisabetta Tonet  1 , Elisa Maietti  2 , Giorgio Chiaranda  3 , Francesco Vitali  1 , Matteo Serenelli  1 , Giulia Bugani  1 , Gianni Mazzoni  4 , Rossella Ruggiero  1 , Jonathan Myers  5 , Giovanni Quinto Villani  6 , Ursula Corvi  6 , Giovanni Pasanisi  7 , Simone Biscaglia  1 , Rita Pavasini  1 , Giulia Ricci Lucchi  8 , Gianluigi Sella  9 , Roberto Ferrari  1   10 , Stefano Volpato  2 , Gianluca Campo  11   12 , Giovanni Grazzi  4
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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

Elisabetta Tonet et al. BMC Cardiovasc Disord. .

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.

Keywords: Acute coronary syndrome; Handgrip; Physical activity; Short physical performance battery.

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Conflict of interest statement

Ethics approval and consent to participate

The study protocol has been approved by the hospitals’ ethics committee prior to the study beginning (November 2016, study ID 161098). An approved written informed consent is obtained from all patients at the time of enrolment.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of the study. The figure shows the study flow chart for patients admitted to hospital with acute coronary syndrome diagnosis. SPPB: short physical performance battery. ACS: acute coronary syndrome
See this image and copyright information in PMC

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