PHYSICAL ACTIVITYNCT05422950
Relationship of Physical Condition and Functionality in Post-covid Patients
An observational study of PHYSICAL ACTIVITY, run by Universidad Nacional de Colombia at 1 site in Colombia.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- PHYSICAL ACTIVITY
- What is being tested?
- Relationship between physical condition and functionality in post-covid patients
- How many people
- 50 participants
- Where
- 1 siteColombia
- Study dates
- 1 Feb 2021to 10 Dec 2021
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- PHYSICAL ACTIVITY
- Being tested
- Relationship between physical condition and functionality in post-covid patients
- Keywords
- Covid-19; ICU; Physical deconditioning; Quality of life.
- Medical subject headings
- Motor Activity, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relationship between physical condition and functionality in post-covid patientsOther
Correlation study between the physical condition and functionality of patients after intubation due to covid 19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Feb 2021
- Primary completion10 Jul 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PHYSICAL ACTIVITYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422950
- Sponsor's protocol ID
- 013-116
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05422950
- Acronym / sponsor ID
- 013-116
- Conditions
- PHYSICAL ACTIVITY
- Keywords
- Covid-19; ICU; Physical deconditioning; Quality of life.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 10 Jul 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relationship between physical condition and functionality in post-covid patientsCorrelation study between the physical condition and functionality of patients after intubation due to covid 19 | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PHYSICAL ACTIVITY, run by Universidad Nacional de Colombia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.