Relationship of Physical Condition and Functionality in Post-covid Patients

June 15, 2022 updated by: Universidad Nacional de Colombia

Relationship Between the Physical Condition and Functionality of Patients Post Intubation by Covid-19 With the Time of Stay in ICU an Stageof the Disease.

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

Study Overview

Detailed Description

This research was developed in four phases:

Phase 1. Population selection The selection of post-intubated patients, who were discharged from the ICUs of Pasto in the months of June and July 2021, was made contact with patients and relatives two or three days before they are discharged from the ICU. One month after hospital discharge, the inclusion and non-inclusion criteria were contacted and verified, the study objectives were explained to patients and family members, then the informed consent was sent and completed. carried out the programming of the users for the respective data collection, the tests were carried out during the following month after being discharged from the ICU. The tests were carried out in person at the residence of each participant or that of the researcher. For the purposes of carrying out the tests, the patient had a companion in order to minimize the risks and ensure the correct application of the tests. Management and preparation guidelines for the tests were indicated to patients and family members.

Phase 2: Evaluation and data collection The population was assessed one month after being discharged. The researcher brought the necessary utensils to the agreed place for the execution of the tests. The study participants were verbally explained the objectives of the research, the procedure that was carried out and the signing of the informed consent was verified. Subsequently, the tests chosen by the researcher were evaluated and applied, taking into account aspects such as order, space and time.

Phase 3: Data tabulation and analysis Once the population data had been collected, the respective tabulation and analysis was carried out.

Phase 4: Results, discussion and conclusions Data analysis was performed to carry out the writing and analysis of the results, discussion, conclusions and limitations of the study.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

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

Study Locations

      • Bogota, Colombia
        • Universidad Nacional

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 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability 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).

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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
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.
Time Frame: one year
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

Collaborators and Investigators

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

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 (ACTUAL)

February 1, 2021

Primary Completion (ACTUAL)

July 10, 2021

Study Completion (ACTUAL)

December 10, 2021

Study Registration Dates

First Submitted

June 15, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (ACTUAL)

June 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 15, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 013-116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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