Reliability (Test-retest) of 30 Seconds Sit-to-stand and Timed Up and Go in Adults With Long Covid

Long COVID Clinical Trial

Official title:

Reliability of 30 Seconds Sit-to-stand and Timed Up and Go in Adults With Long Covid

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05886842
• Other study ID #: Test-Retest
• Status: Recruiting
• Start date: December 21, 2022
• Est. completion date: August 21, 2025

Study information

• Verified date: February 2024
• Source: European University Cyprus
• Contact: Marina E Kloni
• Phone: 00357 99007245
• Email: marina.eleni[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: August 21, 2025
• Est. primary completion date: December 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Long COVID

Intervention

Other:
• Test-retest
Test-retest

Locations

Country	Name	City	State
Cyprus	Eden resort wellness rehabilitation	Larnaca

Sponsors (2)

Lead Sponsor	Collaborator
European University Cyprus	Eden Resort Wellness Rehabilitation Center

Country where clinical trial is conducted

Cyprus, 

References & Publications (12)

Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. — View Citation

Donner A, Eliasziw M. Sample size requirements for reliability studies. Stat Med. 1987 Jun;6(4):441-8. doi: 10.1002/sim.4780060404. — View Citation

Figueiredo PHS, Veloso LRS, Lima MMO, Vieira CFD, Alves FL, Lacerda ACR, Lima VP, Rodrigues VGB, Maciel EHB, Costa HS. The reliability and validity of the 30-seconds sit-to-stand test and its capacity for assessment of the functional status of hemodialysis patients. J Bodyw Mov Ther. 2021 Jul;27:157-164. doi: 10.1016/j.jbmt.2021.02.020. Epub 2021 Mar 4. — View Citation

Hansen H, Beyer N, Frolich A, Godtfredsen N, Bieler T. Intra- and inter-rater reproducibility of the 6-minute walk test and the 30-second sit-to-stand test in patients with severe and very severe COPD. Int J Chron Obstruct Pulmon Dis. 2018 Oct 18;13:3447-3457. doi: 10.2147/COPD.S174248. eCollection 2018. — View Citation

Karagiannis C, Savva C, Korakakis V, Matheou I, Adamide T, Georgiou A, Xanthos T. Test-Retest Reliability of Handgrip Strength in Patients with Chronic Obstructive Pulmonary Disease. COPD. 2020 Oct;17(5):568-574. doi: 10.1080/15412555.2020.1808604. Epub 2020 Aug 19. — View Citation

Myles PS, Cui J. Using the Bland-Altman method to measure agreement with repeated measures. Br J Anaesth. 2007 Sep;99(3):309-11. doi: 10.1093/bja/aem214. No abstract available. — View Citation

Ozcan Kahraman B, Ozsoy I, Akdeniz B, Ozpelit E, Sevinc C, Acar S, Savci S. Test-retest reliability and validity of the timed up and go test and 30-second sit to stand test in patients with pulmonary hypertension. Int J Cardiol. 2020 Apr 1;304:159-163. doi: 10.1016/j.ijcard.2020.01.028. Epub 2020 Jan 15. — View Citation

Savva C, Giakas G, Efstathiou M, Karagiannis C. Test-retest reliability of handgrip strength measurement using a hydraulic hand dynamometer in patients with cervical radiculopathy. J Manipulative Physiol Ther. 2014 Mar-Apr;37(3):206-10. doi: 10.1016/j.jmpt.2014.02.001. Epub 2014 Mar 11. — View Citation

Shechtman O, Gestewitz L, Kimble C. Reliability and validity of the DynEx dynamometer. J Hand Ther. 2005 Jul-Sep;18(3):339-47. doi: 10.1197/j.jht.2005.04.002. — View Citation

Shrout PE. Measurement reliability and agreement in psychiatry. Stat Methods Med Res. 1998 Sep;7(3):301-17. doi: 10.1177/096228029800700306. — View Citation

Steffen TM, Hacker TA, Mollinger L. Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Phys Ther. 2002 Feb;82(2):128-37. doi: 10.1093/ptj/82.2.128. — View Citation

Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998 Jan 15;17(1):101-10. doi: 10.1002/(sici)1097-0258(19980115)17:13.0.co;2-e. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability of 30 seconds Sit to stand	Test-retest that assess the reliability of 30 seconds Sit to Stand	Two occasions within approximately three days to establish intra rater reliability
Primary	Reliability of Timed Up and Go	Test-retest that assess the reliability of Timed Up and Go	Two occasions within approximately three days to establish intra rater reliability