Clinical trial NCT05064943: Reliability and Validity of the 2-Minute Step Test in Patients With Knee Arthroplasty
Official title: Reliability and Validity of the 2-Minute Step Test in Patients With Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Replacement
Reliability and Validity
Keywords: Total Knee Replacement
Step Test
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have undergone total knee replacement surgery with age of older than 18.

Brief summary: Total knee arthroplasty (TKA) is a cost-effective treatment for end-stage knee osteoarthritis. It has demonstrable benefits such as reducing pain and improving activity and quality of life. Despite the decrease in pain after surgery, the expectations of patients regarding their physical functions are not fully realized. Physical performance tests and reporting tests are used to objectively evaluate physical function and reveal the patient's condition. It is known that physical performance tests better reflect post-surgical changes. In addition, it has been stated that there may be serious differences between the results of the reports based tests and the actual functional capacities of the patients. The 2-minute walk test and the 6-minute walk test are tests that are used in the evaluation of lower extremity physical performance and have been shown to be valid and reliable in different populations. However, a certain length of corridor is needed in order to carry out these timed walking tests. As an alternative to these, another test used in the evaluation of physical performance is the 2-minute step test. This test, which was developed in 1999, does not require much equipment and space, so the test can be easily applied in any environment. In this test, a height specific to each individual is determined (as high from the ground as the distance between the Spina iliaca anterior superior and the midpoint of the patella), and the participant is asked to raise and lower both knees, respectively, to this height for 2 minutes. These tests used in the evaluation of patients should be valid, reliable and sensitive. In clinical studies, reliability is an important psychometric property. Because stable data are necessary to provide accurate data on treatment effects or the amount of change observed over time. Another important psychometric property is validity. Validity is defined as the degree to which a concept is accurately measured in a quantitative study. Reliability studies of the 2-minute step test in active and sedentary lean adults have been conducted, but the psychometric evaluations necessary for its routine use in patients with TDP have not been performed.

Detailed description: This study is a non-experimental, descriptive methodological study. Forty-nine patients who applied to the outpatient clinic of Kütahya Health Sciences University, Evliya Çelebi Training and Research Hospital due to knee osteoarthritis, will included in the study. Pre-study power analysis was performed and the power to detect clinically significant difference was calculated as 90% (5% Type I error level). The smallest sample size to be taken was determined by using the sample size creation section in the G-Power (version 3.0.10) program.

Eligibility criteria: Inclusion Criteria:

* Being 18 years or older
* Having been diagnosed with knee OA by an orthopedic specialist and having a knee prosthesis applied.

Exclusion Criteria:

* Those who do not understand verbal and written information in Turkish
* Patients who underwent complex surgery requiring bone grafting
* Those with orthopedic or neurological disease causing gait disturbance
* Those with pain of 5 or more on the numerical pain scale
* Those with a history of Myocardial Infarction
* Those who have undergone surgery in the last 6 months
* Those with concomitant heart failure
* Those with unstable angina
* Those with uncontrolled hypertension
* Those with severe COPD, Asthma and Interstitial Lung Disease

Primary outcomes:
measure: Hospital for Special Surgery Knee-Rating Scale
timeFrame: Baseline
measure: Numerical Pain Scale
timeFrame: Baseline
measure: 2-Minute Step Test
timeFrame: Baseline
measure: 6-Minute Walking Test
timeFrame: Baseline
measure: 2-Minute Walk Test
timeFrame: Baseline
measure: 2-Minute Step Test
timeFrame: Within same day after the baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
affiliation: Kutahya Health Sciences University
name: Hakan Akkan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nogueira MA, Almeida TDN, Andrade GS, Ribeiro AS, Rego AS, Dias RDS, Ferreira PR, Penha LRLN, Pires FO, Dibai-Filho AV, Bassi-Dibai D. Reliability and Accuracy of 2-Minute Step Test in Active and Sedentary Lean Adults. J Manipulative Physiol Ther. 2021 Feb;44(2):120-127. doi: 10.1016/j.jmpt.2020.07.013. Epub 2021 Jan 9.
citation: Ricci PA, Cabiddu R, Jurgensen SP, Andre LD, Oliveira CR, Di Thommazo-Luporini L, Ortega FP, Borghi-Silva A. Validation of the two-minute step test in obese with comorbibities and morbidly obese patients. Braz J Med Biol Res. 2019;52(9):e8402. doi: 10.1590/1414-431X20198402. Epub 2019 Aug 29.
citation: Braghieri HA, Kanegusuku H, Corso SD, Cucato GG, Monteiro F, Wolosker N, Correia MA, Ritti-Dias RM. Validity and reliability of 2-min step test in patients with symptomatic peripheral artery disease. J Vasc Nurs. 2021 Jun;39(2):33-38. doi: 10.1016/j.jvn.2021.02.004. Epub 2021 Mar 19.
citation: Akkan H, Kaya Mutlu E, Kuyubasi SN. Reliability and validity of the two-minute step test in patients with total knee arthroplasty. Disabil Rehabil. 2024 Jul;46(14):3128-3132. doi: 10.1080/09638288.2023.2239141. Epub 2023 Jul 24.