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NCT Number: NCT04649736

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

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.

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Key information

Conditions

Covid19 Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Mental Health Disorder Nidovirales Infections Personal Satisfaction Pneumonia Pneumonia, Viral Psychological Well-Being RNA Virus Infections Respiration Disorders Respiratory Disease Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Nacional Cayetano Heredia

Lima, 15102, Peru

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Six minute walk distance

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

    Distance walked during 6-minutes (meters)

Secondary outcomes

  1. Forced expiratory volume in the first second

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

    Measured in milliliters by dynamic spirometry

  2. Forced Vital Capacity

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

    Measured in milliliters by dynamic spirometry

  3. Quality of life assessed by the Short Form Health Survey (SF-36) questionnaire

    Time frame: Change from baseline measure at hospital discharge to week 7 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

  4. 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 7 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.

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

    Time frame: Change from baseline measure at hospital discharge to week 7 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.

  6. Anxious symptoms assessed by the Generalized Anxiety Disorder (GAD-7) questionnaire

    Time frame: Change from baseline measure at hospital discharge to week 7 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.

  7. 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 7 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).

  8. 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 7 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)

Sponsors and collaborators

Lead sponsor

Universidad Peruana Cayetano Heredia

Other

Collaborators

  • Johns Hopkins University
  • London School of Hygiene and Tropical Medicine

Registry information

Official study 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

Acronym: WAYRA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2020
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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