- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05422950
Relationship of Physical Condition and Functionality in Post-covid Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Bogota, Colombia
- Universidad Nacional
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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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.
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one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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