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

NCT04649736 | Completed DMC

• 1 other identifier: 202852
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Respiratory Disease; Mental Health Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Six minute walk distance

  Distance walked during 6-minutes (meters)

  Change from baseline measure at hospital discharge to week 7 and 12

Secondary Outcomes (8)

• Forced expiratory volume in the first second

  Change from baseline measure at hospital discharge to week 7 and 12

• Forced Vital Capacity

  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

  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

  Change from baseline measure at hospital discharge to week 7 and 12

• Depressive symptomatology assessed by the Patient Health Questionnaire (PHQ-9)

  Change from baseline measure at hospital discharge to week 7 and 12

Study Arms (2)

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.

Other: Respiratory and psychological rehabilitation

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.

Interventions

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.

Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead
• Johns Hopkins University: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Hospital Nacional Cayetano Heredia

Lima, 15102, Peru

Location

Related Publications (8)

• 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.

  PMID: 32422177 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.

  PMID: 15947329 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.

  PMID: 29089687 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.

  PMID: 32381497 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.

  PMID: 32411496 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.

  PMID: 32379637 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.

  PMID: 31723900 BACKGROUND

• 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.

  PMID: 36108135 DERIVED

MeSH Terms

Conditions

COVID-19; Respiration Disorders; Mental Disorders; Psychological Well-Being

Interventions

Respiratory Rate; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 2, 2020
• Study Start: October 26, 2020
• Primary Completion: June 19, 2021
• Study Completion: June 19, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)