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

Covid19 Clinical Trial

— WAYRA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04649736
• Other study ID #: 202852
• Status: Completed
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: June 19, 2021

Study information

• Verified date: May 2021
• Source: Universidad Peruana Cayetano Heredia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 19, 2021
• Est. primary completion date: June 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Mental Disorders
• Mental Health Disorder
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

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.

Locations

Country	Name	City	State
Peru	Hospital Nacional Cayetano Heredia	Lima

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Peruana Cayetano Heredia	Johns Hopkins University, London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Peru, 

References & Publications (7)

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. — View 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. Review. — View 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. — View 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). pii: 2001217. doi: 10.1183/13993003.01217-2020. Print 2020 Jun. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six minute walk distance	Distance walked during 6-minutes (meters)	Change from baseline measure at hospital discharge to week 7 and 12
Secondary	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
Secondary	Forced Vital Capacity	Measured in milliliters by dynamic spirometry	Change from baseline measure at hospital discharge to week 7 and 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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