Personalized remotely guided preventive exercise therapy for a healthy heart (PRIORITY): protocol for an assessor-blinded, multicenter randomized controlled trial

Frontiers in Cardiovascular Medicine

Cardiovascular Medicine

Emeline M. Van Craenenbroeck¹  Tatiana Kuznetsova²  Guido Claessen³  Youri Bekhuis⁴  Delphine De Smedt⁵  Nick Verhaeghe⁶  Karin Coninx⁷  Matthias Lannoo⁸  Dominique Hansen⁹  Camille De Wilde^1,10  Elise Decorte^1,10  Véronique A. Cornelissen^1,10  Jomme Claes^1,11 

[1] Department of Cardiology, Antwerp University Hospital, Antwerp, Belgium;Department of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium;Department of Cardiovascular Sciences, Faculty of Medicine, KU Leuven, Leuven, Belgium;Department of Cardiovascular Sciences, Faculty of Medicine, KU Leuven, Leuven, Belgium;Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium;Department of Cardiovascular Sciences, Faculty of Medicine, KU Leuven, Leuven, Belgium;REVAL—Rehabilitation Research Centre, Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium;Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium;Department of Public Health and Primary Care, Interuniversity Centre for Health Economics Research, Ghent University, Ghent, Belgium;Department of Public Health and Primary Care, Interuniversity Centre for Health Economics Research, Ghent University, Ghent, Belgium;Department of Public Health, Interuniversity Centre for Health Economics Research, Vrije Universiteit Brussel, Brussels, Belgium;HCI And eHealth, Faculty of Sciences, Hasselt University, Diepenbeek, Belgium;Nutrition & Obesity Unit, Clinical and Experimental Endocrinology, Department of Chronic Diseases, Metabolism and Aging, KU Leuven, Leuven, Belgium;REVAL—Rehabilitation Research Centre, Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium;Research Group of Rehabilitation of Internal Disorders, Department of Rehabilitation Sciences, Faculty of Movement and Rehabilitation Sciences, KU Leuven, Leuven, Belgium;Research Group of Rehabilitation of Internal Disorders, Department of Rehabilitation Sciences, Faculty of Movement and Rehabilitation Sciences, KU Leuven, Leuven, Belgium;Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium;

关键词: exercise;    personalized;    heart failure;    prevention;    obesity;    diabetes;    cost-effectiveness (economics);    randomized controlled trial;   

DOI  :  10.3389/fcvm.2023.1194693

 received in 2023-03-27, accepted in 2023-06-14,  发布年份 2023

来源: Frontiers

【 摘 要 】

AimsA key treatment for patients with varying stages of heart failure with preserved ejection fraction (HFpEF) is exercise. Yet, despite a Class 1A recommendation, only one-third of patients exercise sufficiently. A huge treatment gap exists between guidelines and clinical practice. PRIORITY aims to establish the feasibility, clinical effectiveness and cost-effectiveness of a hybrid centre and home-based personalized exercise and physical activity intervention for patients along the HFpEF continuum.MethodsAn assessor-blinded, multicenter randomized controlled trial will be conducted among 312 patients along the HFpEF continuum. Participants will be randomized (1:1) to the PRIORITY intervention or a comparator group receiving only a written exercise prescription. Participants in the PRIORITY group will receive 18 supervised centre-based exercise sessions during one year, supplemented with a remotely guided home-based physical activity program. Outcomes will be assessed at baseline, 4 months, one and two years. The primary outcome is the peak oxygen uptake (pVO2) at 1-year. Secondary outcomes include physical activity, other physical fitness parameters, cardiovascular health, echocardiographic parameters, health-related quality of life and costs at 1-year FU. Machine learning algorithms will analyse big data on physical activity collected during the 1-year intervention to develop models that can predict physical activity uptake and adherence as well as changes in fitness and health. A cost-utility analysis will be performed to evaluate the cost-effectiveness of the PRIORITY intervention compared to the control condition.DiscussionWe anticipate that participants in the supervised home-based exercise intervention group will have a greater increase in pVO2 compared to those receiving a written exercise prescription.Trial registration numberThis trial is registered at ClinicalTrials.gov (NCT04745013) and is currently in the recruitment stage.

【 授权许可】

Unknown   
© 2023 De Wilde, Bekhuis, Kuznetsova, Claes, Claessen, Coninx, Decorte, De Smedt, Hansen, Lannoo, Van Craenenbroeck, Verhaeghe and Cornelissen.