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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| London School of Hygiene and Tropical Medicine | OTHER |
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Some COVID-19 survivors may have respiratory and mental health sequelae, especially those who required hospitalization. The investigators hypothesize that the participation of a rehabilitation program composite by home-based respiratory physiotherapy and telephone-based psychological support will improve respiratory function, quality of life, and psychological status in severe COVID-19 patients.
In Peru, almost one million persons have survived COVID-19 and initial reports indicate that could exist long-term health damage. This study aims to assess the efficacy of a 6-week rehabilitation program following hospital discharge for patients who had severe COVID-19. The program includes 12 sessions of home-based respiratory therapy that the patient will carry out with a physiotherapist and 7 sessions of telephone-based psychological support bring by a psychologist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support | Experimental | Participants in the intervention arm will receive the conventional care given by the hospital that consists of discharged recommendations and a follow-up plan through telephone calls to verify treatment compliance. Discharged recommendations include performing respiratory exercises at home and medication. There is no plan for diagnosing mental illness or a strategy for respiratory o psychological rehabilitation at the hospital. Additionally, these participants will receive the intervention program that involves home-based respiratory physiotherapy and telephone-based psychological support for 6 weeks. |
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| Control | No Intervention | Participants in the control arm will only receive the conventional care given by the hospital that consists of discharged recommendations and a follow-up plan through telephone calls to verify treatment compliance. Discharged recommendations include performing respiratory exercises at home and medication. There is no plan for diagnosing mental illness or a strategy for respiratory o psychological rehabilitation at the hospital. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory and psychological rehabilitation | Other | Respiratory rehabilitation consists of 12 sessions of respiratory and physical exercises that patients perform at home with the help of a physiotherapist. Sessions have 1 hour of duration and are performing twice a week. Exercises include (1) Training of the respiratory muscles through pursed-lip breaths. (2) Effective cough exercises. (3) Diaphragmatic contractions in a supine position with a lightweight placed on the anterior abdominal wall. (4) Stretching exercise of extremities and the back. The psychological support consists of 1 session to make the psychological history of the participant, and 6 sessions of emotion-centered problem-solving therapy, with cognitive-behavioral components and psychological management of emergencies and crises. These sessions have a 1-hour duration and are telephone-provided once a week by psychologists following the guidelines of the Inter-Agency Standing Committee on Mental Health and Psychosocial Support in Humanitarian and Disaster Emergencies. |
| Measure | Description | Time Frame |
|---|---|---|
| Six minute walk distance | Distance walked during 6-minutes (meters) | Change from baseline measure at hospital discharge to week 7 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in the first second | Measured in milliliters by dynamic spirometry | Change from baseline measure at hospital discharge to week 7 and 12 |
| Forced Vital Capacity | Measured in milliliters by dynamic spirometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andres G Lescano, PhD, MHS | Universidad Peruana Cayetano Heredia | Principal Investigator |
| William Checkley, MD, PhD | Johns Hopkins University | Principal Investigator |
| Stella M Hartinger, MSc, PhD | Universidad Peruana Cayetano Heredia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nacional Cayetano Heredia | Lima | 15102 | Peru |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32422177 | Background | Spagnolo P, Balestro E, Aliberti S, Cocconcelli E, Biondini D, Casa GD, Sverzellati N, Maher TM. Pulmonary fibrosis secondary to COVID-19: a call to arms? Lancet Respir Med. 2020 Aug;8(8):750-752. doi: 10.1016/S2213-2600(20)30222-8. Epub 2020 May 15. No abstract available. | |
| 15947329 | Background | Xie L, Liu Y, Xiao Y, Tian Q, Fan B, Zhao H, Chen W. Follow-up study on pulmonary function and lung radiographic changes in rehabilitating severe acute respiratory syndrome patients after discharge. Chest. 2005 Jun;127(6):2119-24. doi: 10.1378/chest.127.6.2119. |
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Results will be published in an indexed peer-review journals.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012120 | Respiration Disorders |
| D001523 | Mental Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D056152 | Respiratory Rate |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Change from baseline measure at hospital discharge to week 7 and 12 |
| Quality of life assessed by the Short Form Health Survey (SF-36) questionnaire | The SF-36 questionnaire consists of 36 items, which are used to calculate eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The first four scores can be summed to create the physical composite score (PCS), while the last four can be summed to create the mental composite score (MCS). Scores for the SF-36 scales range between 0 and 100, with higher scores indicating a better health-related quality of life | Change from baseline measure at hospital discharge to week 7 and 12 |
| Quality of life assessed by the Health-Related Quality of Life (EQ-5D) questionnaire | EQ-5D is a standardized tool for the assessment of quality of life in 5 different dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Possible scores range from 1 (No problem) to 3 (Extreme problems) and each dimension are evaluated individually. | Change from baseline measure at hospital discharge to week 7 and 12 |
| Depressive symptomatology assessed by the Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire-9 (PHQ-9) consists of nine items covering the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for major depression scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 27. A greater score means worse depressive symptoms. | Change from baseline measure at hospital discharge to week 7 and 12 |
| Anxious symptoms assessed by the Generalized Anxiety Disorder (GAD-7) questionnaire | The Generalized Anxiety Disorder-7 (GAD-7) consists of seven items covering the DSM-IV criteria for GAD scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 21. A higher score means worse anxiety symptoms. | Change from baseline measure at hospital discharge to week 7 and 12 |
| Post-traumatic stress disorder symptomatology assessed by the Impact of Event Scale Revised (IES-R) questionnaire. | IES-R consists of 21 items covering the DSM-IV criteria for PTSD. Score varying from 0 (no risk of post traumatic stress) to 88 (highest risk of post traumatic stress). | Change from baseline measure at hospital discharge to week 7 and 12 |
| Impact on overall health by respiratory diseases assessed by the score of the St. George's respiratory questionnaire (SGRQ) | The SGRQ scores from 0 (no impairment of quality of life by respiratory diseases/symptoms) to 100 (highest impairment of quality of life by respiratory diseases/symptoms) | Change from baseline measure at hospital discharge to week 7 and 12 |
| 29089687 | Background | Das KM, Lee EY, Singh R, Enani MA, Al Dossari K, Van Gorkom K, Larsson SG, Langer RD. Follow-up chest radiographic findings in patients with MERS-CoV after recovery. Indian J Radiol Imaging. 2017 Jul-Sep;27(3):342-349. doi: 10.4103/ijri.IJRI_469_16. |
| 32381497 | Background | Mo X, Jian W, Su Z, Chen M, Peng H, Peng P, Lei C, Chen R, Zhong N, Li S. Abnormal pulmonary function in COVID-19 patients at time of hospital discharge. Eur Respir J. 2020 Jun 18;55(6):2001217. doi: 10.1183/13993003.01217-2020. Print 2020 Jun. |
| 32411496 | Background | Yang LL, Yang T. Pulmonary rehabilitation for patients with coronavirus disease 2019 (COVID-19). Chronic Dis Transl Med. 2020 May 14;6(2):79-86. doi: 10.1016/j.cdtm.2020.05.002. eCollection 2020 Jun. |
| 32379637 | Background | 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. Epub 2020 Apr 1. |
| 31723900 | Background | Jang MH, Shin MJ, Shin YB. Pulmonary and Physical Rehabilitation in Critically Ill Patients. Acute Crit Care. 2019 Feb;34(1):1-13. doi: 10.4266/acc.2019.00444. Epub 2019 Feb 28. |
| 36108135 | Derived | Soriano-Moreno AN, Flores EC, Hartinger SM, Mallma CY, Diaz AA, Gianella GE, Galvez-Buccollini JA, Coico-Lama AH, Malaga G, Fajardo E, Paredes-Angeles R, Otazu-Alfaro S, Lescano AG, Checkley W; WAYRA Trial Investigators. Home-Based Respiratory Physiotherapy and Telephone-Based Psychological Support for COVID-19 Survivors in Peru: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 24;11(10):e36001. doi: 10.2196/36001. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D012119 |
| Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |