Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support in Severe COVID-19 Patients (WAYRA)
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|ClinicalTrials.gov Identifier: NCT04649736|
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : December 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Respiratory Disease Mental Health Disorder||Other: Respiratory and psychological rehabilitation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- Six minute walk distance [ Time Frame: Change from baseline measure at hospital discharge to week 6 and 12 ]Distance walked during 6-minutes (meters)
- 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)
- 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.
- 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.
- 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
- 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.
- 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
- Forced Vital Capacity [ Time Frame: Change from baseline measure at hospital discharge to week 6 and 12 ]Measured in milliliters by dynamic spirometry
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649736
|Contact: Anderson N. Soriano-Moreno, MD||99911-3385 ext +firstname.lastname@example.org|
|Hospital Nacional Cayetano Heredia||Recruiting|
|Lima, Peru, 15102|
|Contact: Germán Málaga, MD, MSc 99276-8300 ext +51 email@example.com|
|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|