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

• ClinicalTrials.gov Identifier: NCT04649736
• Recruitment Status: Recruiting
• First Posted: December 2, 2020
• Last Update Posted: December 2, 2020
• Sponsor: Universidad Peruana Cayetano Heredia
• Collaborators: Johns Hopkins University; London School of Hygiene and Tropical Medicine
• Information provided by (Responsible Party): Universidad Peruana Cayetano Heredia

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Covid19; Respiratory Disease; Mental Health Disorder	Other: Respiratory and psychological rehabilitation	Not Applicable

Detailed Description:

In Peru, almost one million persons have survived to 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 discharged 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 6 sessions of telephone-based psychological support bring by a psychologist.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: October 26, 2020
• Estimated Primary Completion Date: March 30, 2021
• Estimated Study Completion Date: March 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support; Participants will be referred to the medical rehabilitation service with the indication to continue outpatient therapy and additionally will receive home-based respiratory physiotherapy and telephone-based psychological support for 12 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 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 of the World Health Organization.
No Intervention: Control; Participants will be referred to the medical rehabilitation service with the indication to continue outpatient therapy.

Outcome Measures

Primary Outcome Measures :

1. Six minute walk distance [ Time Frame: Change from baseline measure at hospital discharge to week 6 and 12 ]
   Distance walked during 6-minutes (meters)

Secondary Outcome Measures :

1. Impact on overall health by respiratory diseases assessed by the score of the St. George's respiratory questionnaire (SGRQ) [ Time Frame: Change from baseline measure at hospital discharge to week 6 and 12 ]
   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)
2. Depressive symptomatology assessed by the Patient Health Questionnaire (PHQ-9) [ Time Frame: Change from baseline measure at hospital discharge to week 6 and 12 ]
   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.
3. Anxious symptoms assessed by the Generalized Anxiety Disorder (GAD-7) questionnaire [ Time Frame: Change from baseline measure at hospital discharge to week 6 and 12 ]
   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.
4. Quality of life assessed by the Short Form Health Survey (SF-36) questionnaire [ Time Frame: Change from baseline measure at hospital discharge to week 6 and 12 ]
   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
5. Quality of life assessed by the Health-Related Quality of Life (EQ-5D) questionnaire [ Time Frame: Change from baseline measure at hospital discharge to week 6 and 12 ]
   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.
6. Forced expiratory volume in the first second [ Time Frame: Change from baseline measure at hospital discharge to week 6 and 12 ]
   Measured in milliliters by dynamic spirometry
7. Forced Vital Capacity [ Time Frame: Change from baseline measure at hospital discharge to week 6 and 12 ]
   Measured in milliliters by dynamic spirometry
8. Post-traumatic stress disorder symptomatology assessed by the Impact of Event Scale Revised (IES-R) questionnaire. [ Time Frame: Change from baseline measure at hospital discharge to week 6 and 12 ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age between 50 and 75 years.
• To be discharged from hospitalization with a diagnosis of COVID-19
• To have the ability to walk independently
• Able to give informed consent.
• Oxygen flow greater than 6lt/min at any time during hospitalization

Exclusion Criteria:

• To have dementia or cognitive impairment, symptomatic psychiatric illness, hearing or visual impairment that might interfere to follow the instructions
• To have a severe co-morbidity that exercise is contraindicated
• Taking any medication for depression, anxiety, or other medication prescribed by a psychiatrist prior to the onset of a COVID-19 condition.
• Chronic Obstructive Pulmonary Disease or any other previous respiratory disease except COVID-19
• Moderate or severe heart disease (Grade III or IV, New York Heart Association)
• Severe depression or suicidal intention
• Contraindications to spirometry.

Contacts and Locations

Contacts

Contact: Anderson N. Soriano-Moreno, MD; 99911-3385 ext +51; anderson.soriano@upch.pe

Locations

Peru

Hospital Nacional Cayetano Heredia; Recruiting

Lima, Peru, 15102

Contact: Germán Málaga, MD, MSc 99276-8300 ext +51 german.malaga@upch.pe

Sponsors and Collaborators

Universidad Peruana Cayetano Heredia

Johns Hopkins University

London School of Hygiene and Tropical Medicine

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

More Information

Publications:

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.

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.

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). pii: 2001217. doi: 10.1183/13993003.01217-2020. Print 2020 Jun.

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. Review.

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. Review.

• Responsible Party: Universidad Peruana Cayetano Heredia
• ClinicalTrials.gov Identifier: NCT04649736
• Other Study ID Numbers: 202852
• First Posted: December 2, 2020
• Last Update Posted: December 2, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Results will be published in an indexed peer-review journals.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universidad Peruana Cayetano Heredia:

COVID-19; Mental Health; Respiratory Function Tests; Physical and Rehabilitation Medicine; Quality of Life

Additional relevant MeSH terms:

Respiration Disorders; Respiratory Tract Diseases; Mental Disorders