Resistance training and clinical status in patients with postdischarge symptoms after COVID-19: protocol for a randomized controlled crossover trial "The EXER-COVID Crossover Study"

Robinson Ramírez-Vélez, Julio Oteiza, Juan Manuel Casas Fernández de Tejerina, Nora García-Alonso, Gaizka Legarra-Gorgoñon, Sergio Oscoz-Ochandorena, Hugo Arasanz, Yesenia García-Alonso, María Correa-Rodríguez, Mikel Izquierdo, Robinson Ramírez-Vélez, Julio Oteiza, Juan Manuel Casas Fernández de Tejerina, Nora García-Alonso, Gaizka Legarra-Gorgoñon, Sergio Oscoz-Ochandorena, Hugo Arasanz, Yesenia García-Alonso, María Correa-Rodríguez, Mikel Izquierdo

Abstract

Background: Physical exercise induces a coordinated response of multiple organ systems, including the immune system. In fact, it has been proposed that physical exercise may modulate the immune system. However, the potential effect of an exercise program on COVID-19 survivors has not been investigated. Thus, the aim of this study is to evaluate the modifications in immunological parameters, physical condition, inflammatory profile, and perceived persistent symptoms after 6 weeks of supervised resistance training (RT), in addition to the standard care on the clinical status of patients with persistent COVID-19 symptoms. The objective of this protocol is to describe the scientific rationale in detail and to provide information about the study procedures.

Methods/design: A total of 100 patients with postdischarge symptoms after COVID-19 will be randomly allocated into either a group receiving standard care (control group) or a group performing a multicomponent exercise program two times a week over a period of 6 weeks. The main hypothesis is that a 6-week multicomponent exercise program (EXER-COVID Crossover Study) will improve the immunological and inflammatory profile, physical condition, and persistent perceived symptoms (fatigue/tiredness, musculoskeletal pain, and shortness of breath) in patients with postdischarge symptoms after COVID-19.

Discussion: Our results will provide insights into the effects of a multicomponent exercise program on immunological parameters, physical condition, inflammatory profile, and persistent perceived symptoms in patients with postdischarge symptoms after COVID-19. Information obtained by this study will inform future guidelines on the exercise training rehabilitation of patients with postdischarge symptoms after COVID-19.

Trial registration: NCT04797871 , Version 2. Registered on March 15, 2021.

Keywords: COVID-19; Immunology; Inflammation; Multicomponent exercise.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Schedule illustrating enrolment and interventions (SPIRIT figure) of the “EXER-COVID Crossover Study”. T: time-point; *According to SPIRIT 2013 statement. ** A random subsample of participants (20 subjects in each group, n=40)
Fig. 2
Fig. 2
Flow of subjects through the “EXER-COVID Crossover Study”. Participants will be first randomly assigned to a 6-week period of no-exercise training (Sequence 1, n=50) or exercise training (Sequence 2, n=50) after which full crossover occurred. T: time-point; PROMs: patient-reported outcome measures; REE: resting energy expenditure; HRV: heart rate variability; BP: blood pressure

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