NCT04852718

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

Same day

First QC Date

April 15, 2021

Last Update Submit

April 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscular function

    Short Physical Performance Battery (SPPB) value 0-12

    1 year

Secondary Outcomes (3)

  • Health-related Quality of life

    1 year

  • Respiratory muscle function

    1 year

  • Exercise capacity

    1 year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Related Publications (1)

  • Perrot JC, Segura M, Beranuy M, Gich I, Nadal MJ, Pintor A, Terra J, Ramirez E, Paz LD, Bascunana H, Plaza V, Guell-Rous MR. Comparison of post-COVID symptoms in patients with different severity profiles of the acute disease visited at a rehabilitation unit. PLoS One. 2022 Sep 16;17(9):e0274520. doi: 10.1371/journal.pone.0274520. eCollection 2022.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Maria-Rosa Güel-Rous, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria-Rosa Güel-Rous, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2021

First Posted

April 21, 2021

Study Start

April 13, 2021

Primary Completion

April 13, 2021

Study Completion

April 13, 2021

Last Updated

April 21, 2021

Record last verified: 2021-04

Locations