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

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.

Exercise intervention improves quality of life in older adults after myocardial infarction: randomised clinical trial

“…The HULK study was a multicentre, investigator-driven, randomised clinical trial conducted at three sites across the Emilia-Romagna region (Italy) 5. A detailed study outline, a list of the criteria used for inclusion or exclusion in the study and definitions of end points have been previously published 5…”

“…Screening of eligible patients, as well as baseline data collection, was performed during index hospitalisation for ACS, before hospital discharge 5. One-month later (inclusion visit), after re-assessment of inclusion/exclusion criteria and eligibility, patients were randomised either to health education (control group) or exercise intervention (experimental group) 5.…”

“…Screening of eligible patients, as well as baseline data collection, was performed during index hospitalisation for ACS, before hospital discharge 5. One-month later (inclusion visit), after re-assessment of inclusion/exclusion criteria and eligibility, patients were randomised either to health education (control group) or exercise intervention (experimental group) 5. Randomisation was stratified using the following variables: sex (male vs female), clinical presentation (presence or absence of ST-segment elevation), SPPB value (4–6 vs 7–9 points) 5.…”

“…Therefore, the implementation and maintenance of physical activity in this high-risk subgroup of patients is still an unmet clinical need 4. To fill this gap, we designed the Physical Activity Intervention for Elderly Patients with Reduced Physical Performance after ACS (HULK) trial 5. In this study, an early, individualised and progressive, low-cost exercise intervention including few supervised sessions and home-based exercises was assessed and compared with a health education strategy 5.…”

“…To fill this gap, we designed the Physical Activity Intervention for Elderly Patients with Reduced Physical Performance after ACS (HULK) trial 5. In this study, an early, individualised and progressive, low-cost exercise intervention including few supervised sessions and home-based exercises was assessed and compared with a health education strategy 5. We found that the proposed exercise intervention was associated with a high attendance rate and with significant increase in the time engaged in PA and the values of short physical performance battery (SPPB) 6…”