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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04649736
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : December 2, 2020
Sponsor:
Collaborators:
Johns Hopkins University
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia

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.

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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

Resource links provided by the National Library of Medicine


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.



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).



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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.

Information from the National Library of Medicine

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


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

Locations
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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
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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
Publications:

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Responsible Party: Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT04649736    
Other Study ID Numbers: 202852
First Posted: December 2, 2020    Key Record Dates
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.

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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:
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Respiration Disorders
Respiratory Tract Diseases
Mental Disorders