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NCT04852718 Clinical Trial

Rehabilitation Program for the Sequelae of COVID 19 Infection

Covid19 Clinical Trial

— ISIS  

Official title:
Evaluate a Rehabilitation Program for the Sequelae of COVID 19 Infection: Description of a Clinical Practice

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04852718
Other study ID # IIBSP-COV-2020-155
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 13, 2021
Est. completion date April 13, 2021

Study information
Verified date April 2021
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact Maria-Rosa Güel-Rous, PhD
Phone 34935565972
Email mguellr@santpau.cat
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

SUBPROJECT 1: Describe the situation of post-Covid patients in terms of muscle (skeletal and respiratory), cognitive, emotional and health-related quality of life in the 1st visit of the multidisciplinary post-covid rehabilitation consultation at the Hospital. Retrospective observational study. The data collected in clinical records during the first visit in the post-covid Rehabilitation consultation will be analysed. SUBPROJECT 2: Evaluate the response to a personalized rehabilitation program in patients with post-covid sequelae in terms of muscle (skeletal and respiratory), and health-related quality of life. Prospective observational study of a single cohort of patients. The data will be collected from successive clinical visits.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date April 13, 2021
Est. primary completion date April 13, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - • Patients who were diagnosed with Covid-19 pneumonia, confirmed by serological tests or molecular biology test (PCR), and who were at home at the time of the 1st visit. - PCR or serological negative test or more than 28 days after diagnosis. - Dyspnoea in activities of daily living (mMRC = 2), (Annex 5 of the clinical protocol). - Patients who had muscle weakness (Clinical Frailty Scale = 3), (Annex 1 of the clinical protocol). Exclusion Criteria: - Patients with disease activity. - Live outside the reference area of the Hospital de la Santa Creu i Sant Pau. - Patients with cognitive impairment that makes it difficult to carry out the rehabilitation program.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Hospital de la Santa Creu i Sant Pau Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Muscular function Short Physical Performance Battery (SPPB) value 0-12 1 year
Secondary Health-related Quality of life SF36 questionnaire, vaule 0-100 1 year
Secondary Respiratory muscle function Maximal inspiratory pressure (MIP) Maximal expiratory pressure (MEP) 1 year
Secondary Exercise capacity Six-minute walking Test (6MWT): meters, 1 year
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