Clinical trial NCT04649736: Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support in Severe COVID-19 Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Respiratory Disease
Mental Health Disorder
Keywords: COVID-19
Mental Health
Respiratory Function Tests
Physical and Rehabilitation Medicine
Quality of Life
Lead sponsor: Universidad Peruana Cayetano Heredia
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: London School of Hygiene and Tropical Medicine
First posted: 2020-12-02
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Six minute walk distance
timeFrame: Change from baseline measure at hospital discharge to week 7 and 12
Secondary outcomes:
measure: Forced expiratory volume in the first second
timeFrame: Change from baseline measure at hospital discharge to week 7 and 12
measure: Forced Vital Capacity
timeFrame: Change from baseline measure at hospital discharge to week 7 and 12
measure: Quality of life assessed by the Short Form Health Survey (SF-36) questionnaire
timeFrame: Change from baseline measure at hospital discharge to week 7 and 12
measure: Quality of life assessed by the Health-Related Quality of Life (EQ-5D) questionnaire
timeFrame: Change from baseline measure at hospital discharge to week 7 and 12
measure: Depressive symptomatology assessed by the Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline measure at hospital discharge to week 7 and 12
measure: Anxious symptoms assessed by the Generalized Anxiety Disorder (GAD-7) questionnaire
timeFrame: Change from baseline measure at hospital discharge to week 7 and 12
measure: Post-traumatic stress disorder symptomatology assessed by the Impact of Event Scale Revised (IES-R) questionnaire.
timeFrame: Change from baseline measure at hospital discharge to week 7 and 12
measure: Impact on overall health by respiratory diseases assessed by the score of the St. George's respiratory questionnaire (SGRQ)
timeFrame: Change from baseline measure at hospital discharge to week 7 and 12
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Hospital Nacional Cayetano Heredia
Study officials:
affiliation: Universidad Peruana Cayetano Heredia
name: Andres G Lescano, PhD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: William Checkley, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Peruana Cayetano Heredia
name: Stella M Hartinger, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.