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Personalized remotely guided preventive exercise therapy for a healthy heart (PRIORITY): protocol for an assessor-blinded, multicenter randomized controlled trial.
De Wilde, Camille; Bekhuis, Youri; Kuznetsova, Tatiana; Claes, Jomme; Claessen, Guido; Coninx, Karin; Decorte, Elise; De Smedt, Delphine; Hansen, Dominique; Lannoo, Matthias; Van Craenenbroeck, Emeline M; Verhaeghe, Nick; Cornelissen, Véronique A.
Afiliação
  • De Wilde C; Research Group of Rehabilitation of Internal Disorders, Department of Rehabilitation Sciences, Faculty of Movement and Rehabilitation Sciences, KU Leuven, Leuven, Belgium.
  • Bekhuis Y; Department of Cardiovascular Sciences, Faculty of Medicine, KU Leuven, Leuven, Belgium.
  • Kuznetsova T; REVAL-Rehabilitation Research Centre, Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium.
  • Claes J; Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.
  • Claessen G; Department of Cardiovascular Sciences, Faculty of Medicine, KU Leuven, Leuven, Belgium.
  • Coninx K; Research Group of Rehabilitation of Internal Disorders, Department of Rehabilitation Sciences, Faculty of Movement and Rehabilitation Sciences, KU Leuven, Leuven, Belgium.
  • Decorte E; Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.
  • De Smedt D; Department of Cardiovascular Sciences, Faculty of Medicine, KU Leuven, Leuven, Belgium.
  • Hansen D; Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.
  • Lannoo M; HCI And eHealth, Faculty of Sciences, Hasselt University, Diepenbeek, Belgium.
  • Van Craenenbroeck EM; Research Group of Rehabilitation of Internal Disorders, Department of Rehabilitation Sciences, Faculty of Movement and Rehabilitation Sciences, KU Leuven, Leuven, Belgium.
  • Verhaeghe N; Department of Public Health and Primary Care, Interuniversity Centre for Health Economics Research, Ghent University, Ghent, Belgium.
  • Cornelissen VA; REVAL-Rehabilitation Research Centre, Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium.
Front Cardiovasc Med ; 10: 1194693, 2023.
Article em En | MEDLINE | ID: mdl-37456813
ABSTRACT

Aims:

A 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.

Methods:

An assessor-blinded, multicenter randomized controlled trial will be conducted among 312 patients along the HFpEF continuum. Participants will be randomized (11) 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.

Discussion:

We 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 number This trial is registered at ClinicalTrials.gov (NCT04745013) and is currently in the recruitment stage.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies / Qualitative_research Idioma: En Revista: Front Cardiovasc Med Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Bélgica

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies / Qualitative_research Idioma: En Revista: Front Cardiovasc Med Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Bélgica