Previously submitted to: JMIR Research Protocols (no longer under consideration since Dec 28, 2021)
Date Submitted: Oct 31, 2019
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Cardiac rehabilitation in patients with refractory angina trial: rationale and design
ABSTRACT
Background:
Refractory angina is a chronic condition that implies significant impairment in quality of life; its management is a challenge. Current therapies are limited, and new approaches to treatment are needed that target symptoms and quality of life. Evidence is lacking regarding exercise-based cardiac rehabilitation safety and beneficial effects in patients with refractory angina.
Objective:
The aim of the present study is to evaluate the safety and feasibility of exercise-based cardiac rehabilitation in patients with refractory angina, and its effects on angina symptoms, functional capacity, and ischemic burden.
Methods:
This study is an ongoing prospective randomized controlled trial enrolling 52 patients with refractory angina randomized into 2 groups: optimal medical treatment (MT) or MT + exercise-based cardiac rehabilitation (CR) over 12 weeks (36 exercise sessions). Clinical evaluation, cardiopulmonary exercise testing, laboratory tests, and exercise echocardiography are performed before and after intervention. The CR group performs in-hospital exercise sessions. The aerobic training protocol is based on CPT parameters or ischemia/angina threshold. Each cardiac rehabilitation session is 60 minutes long (5 minutes of warm-up, 30 minutes of continuous aerobic exercise based on target heart rate corresponding to anaerobic threshold (AT) obtained in the cardiopulmonary exercise testing OR angina/ischemia threshold if it occurs before the AT, 5 minutes of cooling-down, 15 minutes of resistance training, and 5 minutes of stretching).
Results:
This research study is in progress, with 42 patients recruited as of August 2019. Data collection is expected to be finished before December 2020. No clinical adverse events related to CR have occurred.
Conclusions:
The findings of this study will have important clinical implications in the treatment of refractory angina patients. Clinical Trial: NCT03218891
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.