Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support in Severe COVID-19 Patients (WAYRA)

Prevalence of Altered Pulmonary Function Post-infection by COVID-19 and Impact of Participation in a Pilot Program of Comprehensive Rehabilitation in the Short and Medium-term

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Mental Health Disorder; Respiratory Disease
• Intervention / Treatment: Other: Respiratory and psychological rehabilitation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Peru
  • Lima, Peru, 15102
    • Hospital Nacional Cayetano Heredia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 75 years
• Be discharged from hospitalization with a COVID-19 confirmed diagnosis
• Be able of understanding study procedures
• Be able to give informed consent
• Required oxygen flow greater than 6lt/min or through a high flow device at any time during hospitalization
• Have been evaluated by the rehabilitation service at least once during the hospitalization

Exclusion Criteria:

• Contraindications to six-minute walk test
• Contraindications to spirometry
• Complications during the baseline six-minute walk test
• Have neurological pathology, neuropathy, limb dysfunction, or other underlying physical disability that makes physical exercise impossible
• Be pregnant or breastfeeding
• Do not have access to the Internet or a telephone line
• Have previous lung diseases like asthma, COPD, fibrosis, or tuberculosis
• Moderate or severe heart disease (Grade III or IV, New York Heart Association)
• Have had another severe disease in the last six months
• Severe depression or suicidal intention
• Be taking any medication for depression, anxiety, or other medication prescribed by a psychiatrist prior to the onset of a COVID-19 condition
• Have cognitive impairment or sensory disturbance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support; 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.	Other: Respiratory and psychological rehabilitation; 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.
NO_INTERVENTION: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Universidad Peruana Cayetano Heredia
• Collaborators: London School of Hygiene and Tropical Medicine; Johns Hopkins University
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 26, 2020
• Primary Completion (ACTUAL): June 19, 2021
• Study Completion (ACTUAL): June 19, 2021

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (ACTUAL): December 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 3, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Mental Health; Quality of Life; COVID-19; Respiratory Function Tests; Physical and Rehabilitation Medicine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 202852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results will be published in an indexed peer-review journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No