Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05422950 |
| Other study ID # |
013-116 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
December 10, 2021 |
Study information
| Verified date |
June 2022 |
| Source |
Universidad Nacional de Colombia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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
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.
