Home-Based Respiratory Physiotherapy and Telephone-Based Psychological Support for COVID-19 Survivors in Peru: Protocol for a Randomized Controlled Trial
BackgroundBoth 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....
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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JMIR Publications
2022-10-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2022/10/e36001 |
| _version_ | 1797734555407351808 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Anderson N Soriano-Moreno |
| collection | DOAJ |
| description |
BackgroundBoth 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.
ObjectiveThis 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.
MethodsWAYRA (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.
ResultsThis 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.
ConclusionsWAYRA 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 RegistrationClinicalTrials.gov NCT04649736; https://clinicaltrials.gov/ct2/show/NCT04649736
International Registered Report Identifier (IRRID)RR1-10.2196/36001 |
| first_indexed | 2024-03-12T12:46:03Z |
| format | Article |
| id | doaj.art-0935329f941f40ccafe8cb42e9b7dcae |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-12T12:46:03Z |
| publishDate | 2022-10-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-0935329f941f40ccafe8cb42e9b7dcae2023-08-28T23:18:22ZengJMIR PublicationsJMIR Research Protocols1929-07482022-10-011110e3600110.2196/36001Home-Based Respiratory Physiotherapy and Telephone-Based Psychological Support for COVID-19 Survivors in Peru: Protocol for a Randomized Controlled TrialAnderson N Soriano-Morenohttps://orcid.org/0000-0002-5535-811XElaine C Floreshttps://orcid.org/0000-0002-6195-9595Stella M Hartingerhttps://orcid.org/0000-0003-3523-1725Claudia Y Mallmahttps://orcid.org/0000-0003-0495-2300Arnold A Diazhttps://orcid.org/0000-0003-4659-1048Gonzalo E Gianellahttps://orcid.org/0000-0002-9880-7747Juan A Galvez-Buccollinihttps://orcid.org/0000-0003-2473-9881Abdiel H Coico-Lamahttps://orcid.org/0000-0002-1177-2802German Malagahttps://orcid.org/0000-0002-7828-300XEufemia Fajardohttps://orcid.org/0000-0003-3075-5925Rubí Paredes-Angeleshttps://orcid.org/0000-0003-3669-4932Sharlyn Otazú-Alfarohttps://orcid.org/0000-0002-6462-8716Andres G Lescanohttps://orcid.org/0000-0001-9779-633XWilliam Checkleyhttps://orcid.org/0000-0003-1106-8812 BackgroundBoth 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. ObjectiveThis 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. MethodsWAYRA (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. ResultsThis 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. ConclusionsWAYRA 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 RegistrationClinicalTrials.gov NCT04649736; https://clinicaltrials.gov/ct2/show/NCT04649736 International Registered Report Identifier (IRRID)RR1-10.2196/36001https://www.researchprotocols.org/2022/10/e36001 |
| spellingShingle | 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 Home-Based Respiratory Physiotherapy and Telephone-Based Psychological Support for COVID-19 Survivors in Peru: Protocol for a Randomized Controlled Trial JMIR Research Protocols |
| title | Home-Based Respiratory Physiotherapy and Telephone-Based Psychological Support for COVID-19 Survivors in Peru: Protocol for a Randomized Controlled Trial |
| title_full | Home-Based Respiratory Physiotherapy and Telephone-Based Psychological Support for COVID-19 Survivors in Peru: Protocol for a Randomized Controlled Trial |
| title_fullStr | Home-Based Respiratory Physiotherapy and Telephone-Based Psychological Support for COVID-19 Survivors in Peru: Protocol for a Randomized Controlled Trial |
| title_full_unstemmed | Home-Based Respiratory Physiotherapy and Telephone-Based Psychological Support for COVID-19 Survivors in Peru: Protocol for a Randomized Controlled Trial |
| title_short | Home-Based Respiratory Physiotherapy and Telephone-Based Psychological Support for COVID-19 Survivors in Peru: Protocol for a Randomized Controlled Trial |
| title_sort | home based respiratory physiotherapy and telephone based psychological support for covid 19 survivors in peru protocol for a randomized controlled trial |
| url | https://www.researchprotocols.org/2022/10/e36001 |
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