Adjunctive inspiratory muscle training for patients with COVID-19 (COVIDIMT): protocol for randomised controlled double-blind trial

Abstract

IntroductionA significant number of patients with COVID-19 may experience dyspnoea, anxiety, depression, pain, fatigue and physical impairment symptoms, raising the need for a multidisciplinary rehabilitation approach, especially for those with advanced age, obesity, comorbidities and organ failure. Traditional pulmonary rehabilitation (PR), including exercise training, psychosocial counselling and education, has been employed to improve pulmonary function, exercise capacity and quality of life in patients with COVID-19. However, the effects of inspiratory muscle training (IMT) in PR programmes remain unclear. This study aimed to determine whether the addition of a supervised IMT in a PR is more effective than PR itself in improving dyspnoea, health-related quality of life and exercise capacity in symptomatic patients with post-COVID-19.Methods and analysisThis parallel-group, assessor-blinded randomised controlled trial, powered for superiority, aimed to assess exercise capacity as the primary outcome. A total of 138 are being recruited at two PR centres in Brazil. Following baseline testing, participants will be randomised using concealed allocation, to receive either (1) standard PR with sham IMT or (2) standard PR added to IMT. Treatment effects or differences between the outcomes (at baseline, after 8 and 16 weeks, and after 6 months) of the study groups will be analysed using an ordinary two-way analysis of variance.Ethics and disseminationThis trial was approved by the Brazilian National Ethics Committee and obtained approval on 7 October 2020 (document number 4324069). The findings will be disseminated through publications in peer-reviewed journals and conference presentations.Trial registration numberNCT04595097.

Inspiratory muscle training enhances recovery post-COVID-19: a randomised controlled trial

“…Our higher proportion of females also reflects the suggested distribution of long COVID in the general population [ 38 ], but it precludes gender comparisons. Whilst we had an 8-week waitlist control group, a learning effect may have been evident in the IMT group as no sham IMT protocol was utilised, converse to other ongoing trials [ 39 ]. It is, however, pertinent to note that even low-intensity IMT may elicit a beneficial response, thereby confounding interpretation of the intervention effect.…”

Effects of a cardiopulmonary rehabilitation protocol on functional capacity, dyspnea, fatigue, and body composition in individuals with post‐COVID‐19 syndrome: A randomized controlled trial

“…In this sense, IMT is a viable therapy for PCS. Maldaner et al (2021) et al, 2021). Corroborating this study, individuals in the CPRG submitted to strengthening exercises for the upper limbs (initially with 50% of the maximum load from the incremental test) increased the muscle mass in these limbs compared with CG.…”

Atuação do fisioterapeuta na reabilitação pulmonar de pacientes pós-Covid-19: uma revisão sistemática

“…A prescrição da RP é individualizada, e realizada com exercícios supervisionados, aconselhamento psicossocial e sessões educacionais. Nesse sentido, a adição do treinamento muscular inspiratório (TMI) no programa de RP pode contribuir na redução de dispneia, especialmente em pacientes com fraqueza muscular inspiratória (MALDANER et al, 2021).…”