Effect of a home-based inspiratory muscular training programme on functional capacity in patients with chronic COVID-19 after a hospital discharge: protocol for a randomised control trial (InsCOVID trial)

Patricia Palau, Eloy Domínguez, Clara Sastre, M Luz Martínez, Cruz Gonzalez, Elvira Bondía, Crtstina Albiach, Julio Núñez, Laura López, Patricia Palau, Eloy Domínguez, Clara Sastre, M Luz Martínez, Cruz Gonzalez, Elvira Bondía, Crtstina Albiach, Julio Núñez, Laura López

Abstract

Introduction: Exercise intolerance and fatigue are the most common symptoms in patients with chronic COVID-19 after hospital discharge. Supervised exercise training programmes improve symptoms, but scarce research has been done on home-based exercise programmes on the maximal functional capacity for discharged symptomatic COVID-19 patients. This study evaluates whether a home-based inspiratory muscle training (IMT) programme improves maximal functional capacity in chronic COVID-19 after hospital admission.

Methods and analysis: This single-centre, assessor-blinded randomised controlled trial, powered for superiority, seeks to evaluate maximal functional capacity as the primary endpoint. A total of 26 eligible patients with a previous admission for acute respiratory syndrome coronavirus 2 pneumonia (>3 months after hospital discharge) will be randomised (1:1) to receive a 12-week programme of IMT versus usual care alone. A blinded assessor will measure outcomes at baseline and after the intervention (12 weeks). An analysis of variance will be used to compare continuous outcomes among the two-intervention groups. As of 21 March 2022, eight patients have been enrolled.

Ethics and dissemination: The research ethics committee (Comité Ético de Investigación con Medicamentos de l'Hospital Clínic Universitari de València) approved the protocol following the principles of the Declaration of Helsinki and national regulations (Approval Number: 021/226). Findings will be published in peer-reviewed journals and conference publications.

Trial registration number: NCT05279430.

Keywords: COVID-19; exercise; pneumonia; pulmonary rehabilitation; respiratory muscles.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart for patient inclusion and follow-up. CPET, cardiopulmonary exercise testing; IMT, inspiratory muscle training; peakVO2, peak oxygen consumption at maximal exercise.

References

    1. Pérez-González A, Araújo-Ameijeiras A, Fernández-Villar A, et al. . Long COVID in hospitalized and non-hospitalized patients in a large cohort in northwest Spain, a prospective cohort study. Sci Rep 2022;12:3369. 10.1038/s41598-022-07414-x
    1. Goërtz YMJ, Van Herck M, Delbressine JM, et al. . Persistent symptoms 3 months after a SARS-CoV-2 infection: the post-COVID-19 syndrome? ERJ Open Res 2020;6:00542-2020. 10.1183/23120541.00542-2020
    1. Carfì A, Bernabei R, Landi F, et al. . Persistent symptoms in patients after acute COVID-19. JAMA 2020;324:603–5. 10.1001/jama.2020.12603
    1. Huang C, Huang L, Wang Y, et al. . 6-Month consequences of COVID-19 in patients discharged from Hospital: a cohort study. Lancet 2021;397:220–32. 10.1016/S0140-6736(20)32656-8
    1. Froidure A, Mahsouli A, Liistro G, et al. . Integrative respiratory follow-up of severe COVID-19 reveals common functional and lung imaging sequelae. Respir Med 2021;181:106383. 10.1016/j.rmed.2021.106383
    1. Raman B, Cassar MP, Tunnicliffe EM, et al. . Medium-Term effects of SARS-CoV-2 infection on multiple vital organs, exercise capacity, cognition, quality of life and mental health, post-hospital discharge. EClinicalMedicine 2021;31:100683. 10.1016/j.eclinm.2020.100683
    1. Wu X, Liu X, Zhou Y, et al. . 3-Month, 6-month, 9-month, and 12-month respiratory outcomes in patients following COVID-19-related hospitalisation: a prospective study. Lancet Respir Med 2021;9:747–54. 10.1016/S2213-2600(21)00174-0
    1. Nopp S, Moik F, Klok FA, et al. . Outpatient pulmonary rehabilitation in patients with long COVID improves exercise capacity, functional status, dyspnea, fatigue, and quality of life. Respiration 2022;101:593–601. 10.1159/000522118
    1. Barbara C, Clavario P, De Marzo V, et al. . Effects of exercise rehabilitation in patients with long coronavirus disease 2019. Eur J Prev Cardiol 2022;29:e258–60. 10.1093/eurjpc/zwac019
    1. McNarry MA, Berg RMG, Shelley J, et al. . Inspiratory muscle training enhances recovery post COVID-19: a randomised controlled trial. Eur Respir J 2022;2:2103101. 10.1183/13993003.03101-2021
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Paulus WJ, Tschöpe C, Sanderson JE, et al. . How to diagnose diastolic heart failure: a consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the heart failure and echocardiography associations of the European Society of cardiology. Eur Heart J 2007;28:2539–50. 10.1093/eurheartj/ehm037
    1. Buchholz I, Thielker K, Feng Y-S, et al. . Measuring changes in health over time using the EQ-5D 3L and 5L: a head-to-head comparison of measurement properties and sensitivity to change in a German inpatient rehabilitation sample. Qual Life Res 2015;24:829–35. 10.1007/s11136-014-0838-x
    1. Moawd SA, Azab AR, Alrawaili SM, et al. . Inspiratory muscle training in obstructive sleep apnea associating diabetic peripheral neuropathy: a randomized control study. Biomed Res Int 2020;2020:1–8. 10.1155/2020/5036585
    1. Palau P, Domínguez E, Núñez E, et al. . Effects of inspiratory muscle training in patients with heart failure with preserved ejection fraction. Eur J Prev Cardiol 2014;21:1465–73. 10.1177/2047487313498832
    1. Mancini DM, Brunjes DL, Lala A, et al. . Use of cardiopulmonary stress testing for patients with unexplained dyspnea Post-Coronavirus disease. JACC Heart Fail 2021;9:927–37. 10.1016/j.jchf.2021.10.002
    1. MacIntosh BJ, Ji X, Chen JJ, et al. . Brain structure and function in people recovering from COVID-19 after hospital discharge or self-isolation: a longitudinal observational study protocol. CMAJ Open 2021;9:E1114–9. 10.9778/cmajo.20210023
    1. Rinaldo RF, Mondoni M, Parazzini EM, et al. . Deconditioning as main mechanism of impaired exercise response in COVID-19 survivors. Eur Respir J 2021;58:2100870. 10.1183/13993003.00870-2021
    1. Skjørten I, Ankerstjerne OAW, Trebinjac D, et al. . Cardiopulmonary exercise capacity and limitations 3 months after COVID-19 hospitalisation. Eur Respir J 2021;58:2100996. 10.1183/13993003.00996-2021
    1. Motiejunaite J, Balagny P, Arnoult F, et al. . Hyperventilation as one of the mechanisms of persistent dyspnoea in SARS-CoV-2 survivors. Eur Respir J 2021;58:2101578. 10.1183/13993003.01578-2021
    1. Freire APCF, Lira FS, Morano AEvonA, et al. . Role of body mass and physical activity in autonomic function modulation on Post-COVID-19 condition: an observational subanalysis of Fit-COVID study. Int J Environ Res Public Health 2022;19:2457. 10.3390/ijerph19042457
    1. Szekely Y, Lichter Y, Sadon S, et al. . Cardiorespiratory abnormalities in patients recovering from coronavirus disease 2019. J Am Soc Echocardiogr 2021;34:1273–84. 10.1016/j.echo.2021.08.022
    1. Nasserie T, Hittle M, Goodman SN. Assessment of the frequency and variety of persistent symptoms among patients with COVID-19: a systematic review. JAMA Netw Open 2021;4:e2111417. 10.1001/jamanetworkopen.2021.11417
    1. Shei R-J, Paris HL, Sogard AS, et al. . Time to Move Beyond a "One-Size Fits All" Approach to Inspiratory Muscle Training. Front Physiol 2021;12:766346. 10.3389/fphys.2021.766346
    1. Ramsook AH, Molgat-Seon Y, Schaeffer MR, et al. . Effects of inspiratory muscle training on respiratory muscle electromyography and dyspnea during exercise in healthy men. J Appl Physiol 2017;122:1267–75. 10.1152/japplphysiol.00046.2017
    1. Turner LA, Tecklenburg-Lund SL, Chapman RF, et al. . Inspiratory muscle training lowers the oxygen cost of voluntary hyperpnea. J Appl Physiol 2012;112:127–34. 10.1152/japplphysiol.00954.2011
    1. Witt JD, Guenette JA, Rupert JL, et al. . Inspiratory muscle training attenuates the human respiratory muscle metaboreflex. J Physiol 2007;584:1019–28. 10.1113/jphysiol.2007.140855

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj