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

Sponsor
European University Cyprus (Other)
Overall Status
Recruiting
CT.gov ID
NCT05886842
Collaborator
Eden Resort Wellness Rehabilitation Center (Other)
19
1
12
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Test-retest

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 Design

Study Type:
Observational
Anticipated Enrollment :
19 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Reliability of 30 Seconds Sit-to-stand and Timed Up and Go in Adults With Long Covid
Actual Study Start Date :
Dec 21, 2022
Anticipated Primary Completion Date :
Aug 21, 2023
Anticipated Study Completion Date :
Dec 21, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Other: Test-retest
Test-retest
Other Names:
  • Reliability
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eden resort wellness rehabilitation Larnaca Cyprus 7562

    Sponsors and Collaborators

    • European University Cyprus
    • Eden Resort Wellness Rehabilitation Center

    Investigators

    • Principal Investigator: Marina E Kloni, European University Cyprus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Marina Kloni, Marina Eleni Kloni, BSc, MSc, MA, European University Cyprus
    ClinicalTrials.gov Identifier:
    NCT05886842
    Other Study ID Numbers:
    • Test-Retest
    First Posted:
    Jun 2, 2023
    Last Update Posted:
    Jun 2, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Marina Kloni, Marina Eleni Kloni, BSc, MSc, MA, European University Cyprus
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 2, 2023