Rehabilitation Program for the Sequelae of COVID 19 Infection (ISIS)

April 20, 2021 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

• 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscular function
Time Frame: 1 year
Short Physical Performance Battery (SPPB) value 0-12
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of life
Time Frame: 1 year
SF36 questionnaire, vaule 0-100
1 year
Respiratory muscle function
Time Frame: 1 year
Maximal inspiratory pressure (MIP) Maximal expiratory pressure (MEP)
1 year
Exercise capacity
Time Frame: 1 year
Six-minute walking Test (6MWT): meters,
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 13, 2021

Primary Completion (Anticipated)

April 13, 2021

Study Completion (Anticipated)

April 13, 2021

Study Registration Dates

First Submitted

April 15, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 21, 2021

Last Update Submitted That Met QC Criteria

April 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-COV-2020-155

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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