Home-Based Respiratory Physiotherapy and Telephone-Based Psychological Support for COVID-19 Survivors in Peru: Protocol for a Randomized Controlled Trial

Anderson N Soriano-Moreno, Elaine C Flores, Stella M Hartinger, Claudia Y Mallma, Arnold A Diaz, Gonzalo E Gianella, Juan A Galvez-Buccollini, Abdiel H Coico-Lama, German Malaga, Eufemia Fajardo, Rubí Paredes-Angeles, Sharlyn Otazú-Alfaro, Andres G Lescano, William Checkley, WAYRA Trial Investigators, Carolyn Reuland, Alan Quispe-Sancho, Anderson N Soriano-Moreno, Elaine C Flores, Stella M Hartinger, Claudia Y Mallma, Arnold A Diaz, Gonzalo E Gianella, Juan A Galvez-Buccollini, Abdiel H Coico-Lama, German Malaga, Eufemia Fajardo, Rubí Paredes-Angeles, Sharlyn Otazú-Alfaro, Andres G Lescano, William Checkley, WAYRA Trial Investigators, Carolyn Reuland, Alan Quispe-Sancho

Abstract

Background: Both pulmonary and mental health are affected following hospitalization for COVID-19 pneumonia. Pulmonary rehabilitation therapy has demonstrated benefits in improving mental health, but no validated combined programs that include mental health have been proposed.

Objective: This article presents the design of a trial that aimed to assess whether the participation in a combined rehabilitation program that includes home-based respiratory physiotherapy and telephone-based psychological support is associated with a greater improvement of pulmonary and mental health outcomes 7-12 weeks after COVID-19 hospitalization discharge compared with posthospital usual care provided by a public Peruvian hospital.

Methods: WAYRA (the word for air in the Quechua language) was an open-label, unblinded, two-arm randomized controlled trial. We recruited 108 participants aged 18-75 years who were discharged from the hospital after COVID-19 pneumonia that required >6 liters/minute of supplemental oxygen during treatment. Participants were randomly assigned at a 1:1 ratio to receive the combined rehabilitation program or usual posthospital care provided by a public Peruvian hospital. The intervention consisted of 12 at-home respiratory rehabilitation sessions and 6 telephone-based psychological sessions. The primary outcome was the 6-minute walk distance. Secondary outcomes included lung function, mental health status (depression, anxiety, and trauma), and quality of life. Outcomes were assessed at baseline (before randomization) and at 7 and 12 weeks after hospital discharge to assess the difference between arms.

Results: This study was funded by the Peruvian National Council of Science Technology and Technology Innovation in July 2020. Ethics approval was obtained on September 2, 2020. Recruitment and data collection occurred between October 2020 and June 2021. Results are expected to be published by the end of 2022.

Conclusions: WAYRA was the first randomized controlled trial evaluating combined pulmonary-mental health rehabilitation for hospitalized COVID-19 survivors in resource-limited settings, potentially providing a foundation for the cost-effective scale-up of similar multidisciplinary rehabilitation programs.

Trial registration: ClinicalTrials.gov NCT04649736; https://ichgcp.net/clinical-trials-registry/NCT04649736.

International registered report identifier (irrid): RR1-10.2196/36001.

Keywords: COVID-19; clinical trial; mental health; psychiatric rehabilitation; pulmonary rehabilitation.

Conflict of interest statement

Conflicts of Interest: None declared.

©Anderson N Soriano-Moreno, Elaine C Flores, Stella M Hartinger, Claudia Y Mallma, Arnold A Diaz, Gonzalo E Gianella, Juan A Galvez-Buccollini, Abdiel H Coico-Lama, German Malaga, Eufemia Fajardo, Rubí Paredes-Angeles, Sharlyn Otazú-Alfaro, Andres G Lescano, William Checkley, WAYRA Trial Investigators. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 24.10.2022.

Figures

Figure 1
Figure 1
Expected study enrollment and timeline diagram. 6MWT: 6-minute walk test.

References

    1. Chen C, Haupert SR, Zimmermann L, Shi X, Fritsche LG, Mukherjee B. Global prevalence of post COVID-19 condition or long COVID: a meta-analysis and systematic review. J Infect Dis. 2022 Apr 16;:online ahead of print. doi: 10.1093/infdis/jiac136. 6569364
    1. Lopez-Leon S, Wegman-Ostrosky T, Perelman C, Sepulveda R, Rebolledo P, Cuapio A, Villapol S. More than 50 long-term effects of COVID-19: a systematic review and meta-analysis. Sci Rep. 2021 Aug 09;11(1):16144. doi: 10.1038/s41598-021-95565-8.10.1038/s41598-021-95565-8
    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 May 03;4(5):e2111417. doi: 10.1001/jamanetworkopen.2021.11417. 2780376
    1. Michelen M, Manoharan L, Elkheir N, Cheng V, Dagens A, Hastie C, O'Hara M, Suett J, Dahmash D, Bugaeva P, Rigby I, Munblit D, Harriss E, Burls A, Foote C, Scott J, Carson G, Olliaro P, Sigfrid L, Stavropoulou C. Characterising long COVID: a living systematic review. BMJ Glob Health. 2021 Sep 27;6(9):e005427. doi: 10.1136/bmjgh-2021-005427. bmjgh-2021-005427
    1. Almas T, Malik J, Alsubai AK, Jawad Zaidi SM, Iqbal R, Khan K, Ali M, Ishaq U, Alsufyani M, Hadeed S, Alsufyani R, Ahmed R, Thakur T, Huang H, Antony I, Antony I, Bhullar A, Kotait F, Al-Ani L. Post-acute COVID-19 syndrome and its prolonged effects: an updated systematic review. Ann Med Surg. 2022 Aug;80:103995. doi: 10.1016/j.amsu.2022.103995. S2049-0801(22)00755-5
    1. Living guidance for clinical management of COVID-19. World Health Organization. 2021. [2022-09-16]. .
    1. Maley JH, Alba GA, Barry JT, Bartels MN, Fleming TK, Oleson CV, Rydberg L, Sampsel S, Silver JK, Sipes S, Verduzco-Gutierrez M, Wood J, Zibrak JD, Whiteson J. Multi-disciplinary collaborative consensus guidance statement on the assessment and treatment of breathing discomfort and respiratory sequelae in patients with post-acute sequelae of SARS-CoV-2 infection (PASC) PM R. 2022 Jan 22;14(1):77–95. doi: 10.1002/pmrj.12744.
    1. Fine JS, Ambrose AF, Didehbani N, Fleming TK, Glashan L, Longo M, Merlino A, Ng R, Nora GJ, Rolin S, Silver JK, Terzic CM, Verduzco-Gutierrez M, Sampsel S. Multi-disciplinary collaborative consensus guidance statement on the assessment and treatment of cognitive symptoms in patients with post-acute sequelae of SARS-CoV-2 infection (PASC) PM R. 2022 Jan 12;14(1):96–111. doi: 10.1002/pmrj.12745.
    1. Webber SC, Tittlemier BJ, Loewen HJ. Apparent discordance between the epidemiology of COVID-19 and recommended outcomes and treatments: a scoping review. Phys Ther. 2021 Nov 01;101(11):pzab155. doi: 10.1093/ptj/pzab155. 6307339
    1. Yang L, Yang T. Pulmonary rehabilitation for patients with coronavirus disease 2019 (COVID-19) Chronic Dis Transl Med. 2020 Jun;6(2):79–86. doi: 10.1016/j.cdtm.2020.05.002. S2095-882X(20)30041-4
    1. Liu K, Zhang W, Yang Y, Zhang J, Li Y, Chen Y. Respiratory rehabilitation in elderly patients with COVID-19: a randomized controlled study. Complement Ther Clin Pract. 2020 May;39:101166. doi: 10.1016/j.ctcp.2020.101166. S1744-3881(20)30427-8
    1. Fugazzaro S, Contri A, Esseroukh O, Kaleci S, Croci S, Massari M, Facciolongo NC, Besutti G, Iori M, Salvarani C, Costi S, Reggio Emilia COVID-19 Working Group Rehabilitation interventions for post-acute COVID-19 syndrome: a systematic review. Int J Environ Res Public Health. 2022 Apr 24;19(9):5185. doi: 10.3390/ijerph19095185. ijerph19095185
    1. Bickton FM, Shannon H. Barriers and enablers to pulmonary rehabilitation in low- and middle-income countries: a qualitative study of healthcare professionals. Int J Chron Obstruct Pulmon Dis. 2022;17:141–153. doi: 10.2147/COPD.S348663.348663
    1. Mejía F, Medina C, Cornejo E, Morello E, Vásquez S, Alave J, Schwalb A, Málaga G. Oxygen saturation as a predictor of mortality in hospitalized adult patients with COVID-19 in a public hospital in Lima, Peru. PLoS One. 2020 Dec 28;15(12):e0244171. doi: 10.1371/journal.pone.0244171. PONE-D-20-25433
    1. Antiporta DA, Cutipé YL, Mendoza M, Celentano DD, Stuart EA, Bruni A. Depressive symptoms among Peruvian adult residents amidst a National Lockdown during the COVID-19 pandemic. BMC Psychiatry. 2021 Feb 18;21(1):111. doi: 10.1186/s12888-021-03107-3. 10.1186/s12888-021-03107-3
    1. Dawes P, Pye A, Reeves D, Yeung WK, Sheikh S, Thodi C, Charalambous AP, Gallant K, Nasreddine Z, Leroi I. Protocol for the development of versions of the Montreal Cognitive Assessment (MoCA) for people with hearing or vision impairment. BMJ Open. 2019 Mar 30;9(3):e026246. doi: 10.1136/bmjopen-2018-026246. bmjopen-2018-026246
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377–381. doi: 10.1016/j.jbi.2008.08.010. S1532-0464(08)00122-6
    1. IASC Guidelines on mental health and psychosocial support in emergency settings. Inter-Agency Standing Committee. 2007. [2021-09-23]. .
    1. Cuijpers P, de Wit L, Kleiboer A, Karyotaki E, Ebert DD. Problem-solving therapy for adult depression: an updated meta-analysis. Eur Psychiatry. 2018 Feb 01;48(1):27–37. doi: 10.1016/j.eurpsy.2017.11.006.S0924-9338(17)33012-2
    1. Diniz LS, Neves VR, Starke AC, Barbosa MP, Britto RR, Ribeiro AL. Safety of early performance of the six-minute walk test following acute myocardial infarction: a cross-sectional study. Braz J Phys Ther. 2017 May;21(3):167–174. doi: 10.1016/j.bjpt.2017.03.013. S1413-3555(17)30046-1
    1. Veloso-Guedes C, Rosalen S, Thobias C, Andreotti R, Galhardo F, Oliveira da Silva A, Araujo O, Boin I. Validation of 20-meter corridor for the 6-minute walk test in men on liver transplantation waiting list. Transplant Proc. 2011 May;43(4):1322–1324. doi: 10.1016/j.transproceed.2011.03.057. S0041-1345(11)00572-0
    1. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 01;166(1):111–117. doi: 10.1164/ajrccm.166.1.at1102.
    1. Skloot GS, Edwards NT, Enright PL. Four-year calibration stability of the EasyOne portable spirometer. Respir Care. 2010 Jul;55(7):873–877.
    1. Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70–e88. doi: 10.1164/rccm.201908-1590ST.
    1. Villarreal-Zegarra D, Copez-Lonzoy A, Bernabé-Ortiz A, Melendez-Torres GJ, Bazo-Alvarez JC. Valid group comparisons can be made with the Patient Health Questionnaire (PHQ-9): a measurement invariance study across groups by demographic characteristics. PLoS One. 2019 Sep 9;14(9):e0221717. doi: 10.1371/journal.pone.0221717. PONE-D-19-09035
    1. García-Campayo J, Zamorano E, Ruiz MA, Pardo A, Pérez-Páramo M, López-Gómez V, Freire O, Rejas J. Cultural adaptation into Spanish of the generalized anxiety disorder-7 (GAD-7) scale as a screening tool. Health Qual Life Outcomes. 2010 Jan 20;8(1):8. doi: 10.1186/1477-7525-8-8. 1477-7525-8-8
    1. Gargurevich R, Luyten P, Fils J, Corveleyn J. Factor structure of the Impact of Event Scale-Revised in two different Peruvian samples. Depress Anxiety. 2009 Aug;26(8):E91–E98. doi: 10.1002/da.20430.
    1. Alonso J, Prieto L, Antó JM. The Spanish version of the SF-36 Health Survey (the SF-36 health questionnaire): an instrument for measuring clinical results. Med Clin. 1995 May 27;104(20):771–776.
    1. Konerding U, Elkhuizen SG, Faubel R, Forte P, Malmström T, Pavi E, Janssen MB. The validity of the EQ-5D-3L items: an investigation with type 2 diabetes patients from six European countries. Health Qual Life Outcomes. 2014 Dec 05;12(1):181. doi: 10.1186/s12955-014-0181-5. s12955-014-0181-5
    1. Vilagut G, Ferrer M, Rajmil L, Rebollo P, Permanyer-Miralda G, Quintana J, Santed R, Valderas J, Domingo-Salvany A, Alonso J. El Cuestionario de Salud SF-36 español: una década de experiencia y nuevos desarrollos. Gac Sanit. 2005;19(2):135–150.
    1. Jones PW. St. George's Respiratory Questionnaire: MCID. COPD. 2005 Mar 24;2(1):75–79. doi: 10.1081/copd-200050513.
    1. Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol. 2013 Feb;66(2):197–201. doi: 10.1016/j.jclinepi.2012.09.002.S0895-4356(12)00274-0
    1. Wang Q, Guo Y, Iketani S, Nair MS, Li Z, Mohri H, Wang M, Yu J, Bowen AD, Chang JY, Shah JG, Nguyen N, Chen Z, Meyers K, Yin MT, Sobieszczyk ME, Sheng Z, Huang Y, Liu L, Ho DD. Antibody evasion by SARS-CoV-2 Omicron subvariants BA.2.12.1, BA.4 and BA.5. Nature. 2022 Aug 05;608(7923):603–608. doi: 10.1038/s41586-022-05053-w. 10.1038/s41586-022-05053-w
    1. McGregor G, Sandhu H, Bruce J, Sheehan B, McWilliams D, Yeung J, Jones C, Lara B, Smith J, Ji C, Fairbrother E, Ennis S, Heine P, Alleyne S, Guck J, Padfield E, Potter R, Mason J, Lall R, Seers K, Underwood M. Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN' (REGAIN): a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Jan 06;22(1):8. doi: 10.1186/s13063-020-04978-9. 10.1186/s13063-020-04978-9

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren