Clinical trial NCT05886842: Reliability (Test-retest) of 30 Seconds Sit-to-stand and Timed Up and Go in Adults With Long Covid
Official title: Reliability of 30 Seconds Sit-to-stand and Timed Up and Go in Adults With Long Covid
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Long COVID
Keywords: Test-retest
Reliability
30 seconds Sit to Stand
Timed up and Go
Lead sponsor: European University Cyprus
Sponsor class: OTHER
Collaborators: name: Eden Resort Wellness Rehabilitation Center
First posted: 2023-06-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with a diagnosis of long-covid hospitalised in a rehabilitation center

Brief summary: The goal of this study is to test the reliability (with a test-retest process) of 30 seconds Sit to Stand and Timed Up and Go in an adult population with long-covid, hospitalised in a rehabilitation center.

Detailed description: Since December 2019, Covid-19 has affected millions of people worldwide, leaving many of them with symptoms such as fatigue, (muscle) weakness and dyspnoea, even months after their infection (long covid). Rehabilitation centers were established to aid this new group of patients. This study's aim is to test the reliability of 2 outcome measures for patients with long covid. 30 seconds Sit-To-Stand and Timed Up And Go tests are not specific to a disease but they evaluate functionality, mobility and endurance. They are easy to perform in a clinical setting as they do not require specific equipment. The reliability of the above tests has yet to be established in people with long covid.

A sample size of 19 people will be used. A difference in reliability of 0.9 and 0.7 at 80% power and a 5% level of significance using two ratings was set. Based on two testing sessions, an x value of 0.05, and a power of 0.80, a minimal sample size of 19 patients was identified (Karagiannis et al., 2020).

19 patients with long covid from the rehabilitation center will take both tests in a single day and 3 days later they will take the tests again with no physical therapy intervention in between the measurements.

For the statistical analysis, ICC (Intra-class correlation coefficients), SEM (standard error of measurement) and Bland-Altman plot will be used. These tests evaluate test-retest reliability, through the identification of the agreement of patient's scores between the 2 measurements and they evaluate the measurement precision (Savva et al, 2014).

Eligibility criteria: Inclusion Criteria:

* Adults who were infected with COVID-19 virus in the last 6 months and were diagnosed with long-covid
* Patients must be willing to give written consent for participation in the study
* Negative rapid test for COVID-19

Exclusion Criteria:

* People under 18 years of age
* Significant cognitive and psychiatric impairments (inability to follow simple commands or give consent)
* Refuse to give consent

Primary outcomes:
measure: Reliability of 30 seconds Sit to stand
timeFrame: Two occasions within approximately three days to establish intra rater reliability
measure: Reliability of Timed Up and Go
timeFrame: Two occasions within approximately three days to establish intra rater reliability
Secondary outcomes:
Other outcomes:
Locations:
city: Larnaca
country: Cyprus
facility: Eden resort wellness rehabilitation
Study officials:
affiliation: European University Cyprus
name: Marina E Kloni
role: PRINCIPAL_INVESTIGATOR
References:
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