Total Knee ReplacementNCT05064943
Reliability and Validity of the 2-Minute Step Test in Patients With Knee Arthroplasty
An observational study of Total Knee Replacement and Reliability and Validity, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement, Reliability and Validity
- What is being tested?
- 2-minute step test
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2021to 16 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone total knee replacement surgery with age of older than 18.
Who may be able to join
- Being 18 years or older
- Having been diagnosed with knee OA by an orthopedic specialist and having a knee prosthesis applied.
Who cannot join
- 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
Show all 10Show fewer
- Those with concomitant heart failure
- Those with unstable angina
- Those with uncontrolled hypertension
- Those with severe COPD, Asthma and Interstitial Lung Disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Total Knee Replacement, Reliability and Validity
- Being tested
- 2-minute step test
- Keywords
- Total Knee Replacement, Step Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-minute step testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Replacement | Patients who have undergone total knee replacement Receives: Diagnostic Test: 2-minute step test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital for Special Surgery Knee-Rating Scale
The Hospital for Special Surgery knee-rating scale was developed to be used as a standardized tool to measure outcomes in patients with osteoarthritis and knee arthroplasty. The scale can be used to evaluate the patient before surgery and to monitor knee function after surgery. Hospital for Special Surgery knee rating scale is widely used in the clinic by physiotherapists and orthopaedic surgeons.
Measured: Baseline
Numerical Pain Scale
The pain levels of the patients will be determined using the Numerical Pain Scale (NPS). This scale is a score containing values between 0-10 on a 10 cm horizontal line. In scoring, 0 points indicates the absence of pain, while 10 points means unbearable pain. Patients are asked to mark the part that is equivalent to their own pain on the 10 cm line. Thus, the pain level of the patients is determined.
Measured: Baseline
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.
Measured: Baseline
6-Minute Walking Test
The participant is asked to walk as far as possible along a 30-meter straight corridor in a 6-minute period. Running is not allowed. The evaluator gives the standard incentive "you are doing well, keep going" every minute during the test. The distance traveled in 6 minutes is recorded in meters.
Measured: Baseline
2-Minute Walk Test
Participants are asked to walk within 2 minutes along a 30 m indoor corridor. They are not allowed to talk while walking. The distance walked is recorded in meters.
Measured: Baseline
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.
Measured: Within same day after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start25 Nov 2021
- Primary completion16 Aug 2022
- Study completion16 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan AKKAN, Kutahya Health Sciences University
- Investigators
- Hakan Akkan, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064943
- Sponsor's protocol ID
- KutahyaHSU-AKKAN001
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33431278Ricci 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.
PubMed 31482976Braghieri 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.
PubMed 34120695Akkan 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.
PubMed 37486184
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the 2-Minute Step Test in Patients With Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05064943
- Acronym / sponsor ID
- KutahyaHSU-AKKAN001
- Conditions
- Total Knee Replacement, Reliability and Validity
- Keywords
- Total Knee Replacement, Step Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Knee Replacement | – | Diagnostic Test: 2-minute step testPatients who have undergone total knee replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone total knee replacement surgery with age of older than 18.
Key inclusion criteria (2 listed)
- Being 18 years or older
- Having been diagnosed with knee OA by an orthopedic specialist and having a knee prosthesis applied.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-minute step testThe 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. | Diagnostic test | Total Knee Replacement |
Primary outcome
Hospital for Special Surgery Knee-Rating Scale
Time frame: Baseline
The Hospital for Special Surgery knee-rating scale was developed to be used as a standardized tool to measure outcomes in patients with osteoarthritis and knee arthroplasty. The scale can be used to evaluate the patient before surgery and to monitor knee function after surgery. Hospital for Special Surgery knee rating scale is widely used in the clinic by physiotherapists and orthopaedic surgeons.
Numerical Pain Scale
Time frame: Baseline
The pain levels of the patients will be determined using the Numerical Pain Scale (NPS). This scale is a score containing values between 0-10 on a 10 cm horizontal line. In scoring, 0 points indicates the absence of pain, while 10 points means unbearable pain. Patients are asked to mark the part that is equivalent to their own pain on the 10 cm line. Thus, the pain level of the patients is determined.
2-Minute Step Test
Time frame: Baseline
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.
6-Minute Walking Test
Time frame: Baseline
The participant is asked to walk as far as possible along a 30-meter straight corridor in a 6-minute period. Running is not allowed. The evaluator gives the standard incentive "you are doing well, keep going" every minute during the test. The distance traveled in 6 minutes is recorded in meters.
2-Minute Walk Test
Time frame: Baseline
Participants are asked to walk within 2 minutes along a 30 m indoor corridor. They are not allowed to talk while walking. The distance walked is recorded in meters.
2-Minute Step Test
Time frame: Within same day after the baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 33431278Nogueira 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.
- Background: PubMed 31482976Ricci 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.
- Background: PubMed 34120695Braghieri 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.
- Results publication: PubMed 37486184Akkan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Akkan principal investigator
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Replacement and Reliability and Validity, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital for Special Surgery Knee-Rating Scale (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05064943, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.