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
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Covid19
• Infection

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