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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Universidad Peruana Cayetano Heredia
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Six minute walk distance
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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
- Forced expiratory volume in the first second(Change from baseline measure at hospital discharge to week 7 and 12)
- Forced Vital Capacity(Change from baseline measure at hospital discharge to week 7 and 12)
- Quality of life assessed by the Short Form Health Survey (SF-36) questionnaire(Change from baseline measure at hospital discharge to week 7 and 12)
- Quality of life assessed by the Health-Related Quality of Life (EQ-5D) questionnaire(Change from baseline measure at hospital discharge to week 7 and 12)
- Depressive symptomatology assessed by the Patient Health Questionnaire (PHQ-9)(Change from baseline measure at hospital discharge to week 7 and 12)
- Anxious symptoms assessed by the Generalized Anxiety Disorder (GAD-7) questionnaire(Change from baseline measure at hospital discharge to week 7 and 12)
- Post-traumatic stress disorder symptomatology assessed by the Impact of Event Scale Revised (IES-R) questionnaire.(Change from baseline measure at hospital discharge to week 7 and 12)
- Impact on overall health by respiratory diseases assessed by the score of the St. George's respiratory questionnaire (SGRQ)(Change from baseline measure at hospital discharge to week 7 and 12)