BMJ open · 2019
Effectiveness of combined eccentric and concentric exercise over traditional cardiac exercise rehabilitation programme in patients with chronic heart failure: protocol for a randomised controlled study.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Plaquevent-Hostache Guillaume, Touron Julianne, Costes Frédéric, Perrault Hélène, Clerfond Guillaume, Cuenin Christine, Moisa Andreea, Pereira Bruno, Boiteux Marie-Claire, Eschalier Romain, Richard Ruddy
Аннотация
INTRODUCTION: Exercise-based rehabilitation is a standard feature of chronic heart failure management. The effectiveness of eccentric exercise could offer new opportunities for better tailoring rehabilitation programme to patients' limitations. The goal of the study is to contrast the impact of a mixed eccentric and concentric cycling training programme, to that of conventional concentric cycling rehabilitation in patients with chronic heart failure (peak oxygen consumption (VO2Peak) < 15 mL⋅kg-1⋅min-1, ejection fraction <40%).
METHODS AND ANALYSIS: It is a prospective, open, controlled and randomised study (2×25 subjects) carried out in a single centre. Subjects will perform five exercise sessions per week per the randomisation outcome, with the intervention group performing eccentric in three of the five weekly sessions while the control group will perform the five sessions of concentric exercise. Cycling intensity will be the same in both groups and fixed to the power associated with the first ventilatory threshold. Self-management education programme, callisthenics sessions and muscle strength trainings will also be carried out as for any heart failure patient normally included in the rehabilitation programme. The primary outcome will be the change in distance covered during the 6 min walk test. Secondary outcomes will include other physical mobility parameters, functional exercise capacities, quality of life and body composition as well as skeletal muscle properties including mitochondrial function parameters.
ETHICS AND DISSEMINATION: The study has been approved by the institutional ethics review board (17.079) and the French regulatory authority for research (2017-A00969-44). Adverse events that could occur during the protocol will be reported to the principal investigator. The results will be published in an international peer-reviewed journal.
TRIAL REGISTRATION NUMBER: NCT03716778.
METHODS AND ANALYSIS: It is a prospective, open, controlled and randomised study (2×25 subjects) carried out in a single centre. Subjects will perform five exercise sessions per week per the randomisation outcome, with the intervention group performing eccentric in three of the five weekly sessions while the control group will perform the five sessions of concentric exercise. Cycling intensity will be the same in both groups and fixed to the power associated with the first ventilatory threshold. Self-management education programme, callisthenics sessions and muscle strength trainings will also be carried out as for any heart failure patient normally included in the rehabilitation programme. The primary outcome will be the change in distance covered during the 6 min walk test. Secondary outcomes will include other physical mobility parameters, functional exercise capacities, quality of life and body composition as well as skeletal muscle properties including mitochondrial function parameters.
ETHICS AND DISSEMINATION: The study has been approved by the institutional ethics review board (17.079) and the French regulatory authority for research (2017-A00969-44). Adverse events that could occur during the protocol will be reported to the principal investigator. The results will be published in an international peer-reviewed journal.
TRIAL REGISTRATION NUMBER: NCT03716778.