Reliability and Validity of the 2-Minute Step Test in Patients With Knee Arthroplasty

NCT ID: NCT05064943

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-25

Study Completion Date

2022-08-16

Brief Summary

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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

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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.

Conditions

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Total Knee Replacement Reliability and Validity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Total Knee Replacement

Patients who have undergone total knee replacement

2-minute step test

Intervention Type DIAGNOSTIC_TEST

The participant stands and counts for 2 minutes. The minimum height to raise the knee is determined for each participant by calculating the midpoint between the patella and the anterior superior iliac spine. They are instructed to complete as many steps as possible during the 2-minute period. A verbal command is given every 30 seconds to encourage performance: "You're doing great, keep it up." If the claudication symptom becomes unbearable, the patient can stop during the test, but the time is not stopped. Patients who discontinue testing due to symptoms of claudication are encouraged to return to testing as soon as possible. An evaluator records the number of steps in the right leg.

Interventions

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2-minute step test

The participant stands and counts for 2 minutes. The minimum height to raise the knee is determined for each participant by calculating the midpoint between the patella and the anterior superior iliac spine. They are instructed to complete as many steps as possible during the 2-minute period. A verbal command is given every 30 seconds to encourage performance: "You're doing great, keep it up." If the claudication symptom becomes unbearable, the patient can stop during the test, but the time is not stopped. Patients who discontinue testing due to symptoms of claudication are encouraged to return to testing as soon as possible. An evaluator records the number of steps in the right leg.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kutahya Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Hakan AKKAN

Assistant professor (Principal Investigator)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hakan Akkan

Role: PRINCIPAL_INVESTIGATOR

Kutahya Health Sciences University

Locations

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Kutahya Health Sciences University

Kütahya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 33431278 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31482976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34120695 (View on PubMed)

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.

Reference Type RESULT
PMID: 37486184 (View on PubMed)

Other Identifiers

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KutahyaHSU-AKKAN001

Identifier Type: -

Identifier Source: org_study_id

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