Clinical trial NCT05709262: Comparison of Different Walk and Performance Test in Detecting Silent Hypoxia
Official title: Comparison of Different Walk and Performance Test in Detecting Silent Hypoxia in SARS-CoV-2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
COVID-19 Pneumonia
Oxygen Saturation
Pulmonary Rehabilitation
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will consist of Covid-19 patients hospitalized in the pandemic wards of Kütahya Health Sciences University Physical Medicine and Rehabilitation Additional Service building.

All volunteer patients who meet our inclusion and exclusion criteria will undergo walking field tests with at least 2 hours between them after their written consent is obtained.

Brief summary: Healthcare systems around the world have been dealing with COVID 19. One of the main manifestations of this infection is lung involvement of varying degrees, causing a spectrum of diseases from mild lower respiratory tract infection to severe Adult Respiratory Distress Syndrome (ARDS). One of the important clinical parameters is to detect hypoxia early in order to initiate a higher level of care at the earliest. The presence of silent or latent hypoxia has made this task difficult in COVID 19. Besides, critical findings such as silent hypoxia that is not at rest but triggered by effort can be revealed by some practical field tests such as the 6-minute walk test or the 1-minute chair sit and stand test. Moreover, these simple tools also help to investigate the patient's readiness for discharge. In this way, it will be useful to evaluate their usability in discharge decisions or in determining the post-discharge cardiopulmonary reserves of the patients and therefore their rehabilitation needs. Although walk and performance tests can be performed naturally, safely and simply, more similarly to movements in daily living activities compared to cardiopulmonary exercise tests, the interest in these tests has increased over the years, especially in subjects such as exercise capacity, mortality and morbidity expectation, or oxygen desaturation in patients with chronic cardiopulmonary pathology. The number of studies in 19 patients is quite limited. For this reason, the necessity of new studies on different field tests to detect the presence of latent hypoxia, which expresses the oxygen desaturation triggered by effort, and to evaluate the exercise tolerance status before discharge, has been emphasized in recent reviews.The aim of this study is to determine the presence of silent hypoxia, which expresses the oxygen desaturation triggered by effort, in Covid-19 patients and to compare the different short-term walk and performance tests, which the investigators consider easier and applicable in the conditions of the pandemic environment, with the classical gold standard test ( Six minute walk test) in order to evaluate the exercise tolerance status of the patients before discharge.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of covid 19 between the ages of 18-80
* Patients with a SaO2 value \> 93 in room air
* Patients who do not have dyspnea symptoms in room air during rest
* Patients whose breathing frequence \< 21 at rest
* Patients who can walk independently and get up from their seat
* Patients who did not receive any rehabilitation
* Patients who can cooperate and who are fully oriented
* Patients who volunteered to participate in the study

Exclusion Criteria:

* Severe pnemonia due to Covid-19
* Exacerbation, severe respiratory failure (resting partial pressure of oxygen in standard ambient conditions of less than 55 mmHg), and inability or unwillingness to understand or comply with the study protocol.
* Unable to walk unaided
* Patients diagnosed with vertigo, Meniere, etc. balance disorder and dizziness
* Patients diagnosed with orthostatic hypotension
* Patients diagnosed with neurologic disease such as: stroke, ms-like neuromotor pathology
* pregnant women and those diagnosed with epilepsy
* Patients with BMI \> 35
* Patients with problems in cooperation

Primary outcomes:
measure: Six minute walk test
timeFrame: 10 minutes
measure: Two minute walk test
timeFrame: Baseline
measure: Fourty step walk test
timeFrame: Baseline
measure: 30 Second Sit to Stand Test
timeFrame: Baseline
measure: 1 Minute Sit to Stand Test
timeFrame: Baseline
Secondary outcomes:
measure: Vital measurements before, during and after walk test
timeFrame: Baseline
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University Evliya Celebi Hospital Physical Therapy and Rehabilitation Department
Study officials:
affiliation: Kutahya Health Sciences University
name: Ismail Saracoglu
role: PRINCIPAL_INVESTIGATOR
References: