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ISIS: Rehabilitation Program for the Sequelae of COVID 19 Infection

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Recruiting
CT.gov ID
NCT04852718
Collaborator
(none)
120
Enrollment
1
Location

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluate a Rehabilitation Program for the Sequelae of COVID 19 Infection: Description of a Clinical Practice
    Anticipated Study Start Date :
    Apr 13, 2021
    Anticipated Primary Completion Date :
    Apr 13, 2021
    Anticipated Study Completion Date :
    Apr 13, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Muscular function [1 year]

      Short Physical Performance Battery (SPPB) value 0-12

    Secondary Outcome Measures

    1. Health-related Quality of life [1 year]

      SF36 questionnaire, vaule 0-100

    2. Respiratory muscle function [1 year]

      Maximal inspiratory pressure (MIP) Maximal expiratory pressure (MEP)

    3. Exercise capacity [1 year]

      Six-minute walking Test (6MWT): meters,

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08041

    Sponsors and Collaborators

    • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    Investigators

    • Principal Investigator: Maria-Rosa Güel-Rous, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    ClinicalTrials.gov Identifier:
    NCT04852718
    Other Study ID Numbers:
    • IIBSP-COV-2020-155
    First Posted:
    Apr 21, 2021
    Last Update Posted:
    Apr 21, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Apr 21, 2021