NCT05422950

Brief Summary

Cross-sectional, correlational cohort study where the variables Aerobic endurance (6-minute walk test), Muscle endurance (Medical research council MRC), Flexibility (Sit-and-reach test), Functionality (WHODAS 2.0), Number of days were analyzed hospitalized in the ICU, in post Covid-19 patients after one month of being discharged from the Intensive Care Unit. Users who met the criteria to be part of the research. For the analysis of variables and statistical significance of the results, the SPSS Statistics 22.0 program was used

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

June 15, 2022

Last Update Submit

June 15, 2022

Conditions

Keywords

Covid-19; ICU; Physical deconditioning; Quality of life.

Outcome Measures

Primary Outcomes (1)

  • RELATIONSHIP BETWEEN THE PHYSICAL CONDITION AND FUNCTIONALITY OF PATIENTS POST INTUBATION BY COVID-19 WITH THE TIME OF STAY IN ICU AND STAGE OF THE DISEASE.

    To evaluate the relationship between the days of stay in the ICU with the functionality and physical condition of the post-covid patients after hospital discharge.

    one year

Interventions

Correlation study between the physical condition and functionality of patients after intubation due to covid 19

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study participants will be male and female patients of Colombian nationality, between the ages of 18 to 60 years post-intubated, who have been discharged between June and July 2021 in the intensive care units of the city of Pasto in the department of Nariño, diagnosed with Covid-19 by means of the C-reactive Protein test (CRP).

You may qualify if:

  • Informed consent signature. Patients who have been in the ICU with a diagnosis of Covid-19. Post intubation patients due to Covid-19. Minimum 48 hours of stay in ICU. Maximum 2 months in ICU stay. Men and women between 18 and 60 years of age. Score according to Minmetal Test between 24 and 30. Patients who have undergone physical therapy during their hospitalization.

You may not qualify if:

  • Cognitive impairment that does not allow order tracking. Patients with amputations. Present symptoms of SIRS. Being on supplemental oxygen. Those who die before the evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Nacional

Bogotá, Colombia

Location

MeSH Terms

Conditions

Motor ActivityCOVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 21, 2022

Study Start

February 1, 2021

Primary Completion

July 10, 2021

Study Completion

December 10, 2021

Last Updated

June 21, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations