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

Recruiting

• Conditions: Long COVID
• Interventions: Other: Test-retest

• Registration Number: NCT05886842
• Lead Sponsor: European University Cyprus

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).

Study Timeline

• Study Start: 2022-12-21
• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-12-21
• Study Completion: 2025-08-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Test-retest	Test-retest	A group of 19 patients will be tested using the 30 seconds Sit-to-stand and Timed up and go tests. Each test will be repeated 3 times and the best score will be used. There is going to be 3 days waiting period before the re-tests.

Primary Outcome Measures

Name	Time	Method
Reliability of 30 seconds Sit to stand	Two occasions within approximately three days to establish intra rater reliability	Test-retest that assess the reliability of 30 seconds Sit to Stand
Reliability of Timed Up and Go	Two occasions within approximately three days to establish intra rater reliability	Test-retest that assess the reliability of Timed Up and Go

Trial Locations

Locations (1)

Eden resort wellness rehabilitation; 🇨🇾 Larnaca, Cyprus