Rehabilitation Program for the Sequelae of COVID 19 Infection

• Conditions: Covid19

• Registration Number: NCT04852718
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-13
• Primary Completion: 2021-04-13
• Study Completion: 2021-04-13
• Study First Submitted: 2021-04-15
• Study First Submitted QC: 2021-04-20
• Last Update Submitted: 2021-04-20
• Study First Posted: 2021-04-21
• Last Update Posted: 2021-04-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Muscular function	1 year	Short Physical Performance Battery (SPPB) value 0-12

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain