Rheumatoid Arthritis (RANCT06838884
An Alternative Assessment in Patients with Rheumatoid Arthritis: 6 Minute Step Test
A study testing 6 minutes step test and bicycle ergometer in people with Rheumatoid Arthritis (RA and 6 Minutes Stepper Test, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
Although joint involvement is predominant, RA is a systemic disease that can affect many organs. RA is a disease that includes changes such as inflammation, joint pain, fatigue, increased risk of coronary and heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA, 6 Minutes Stepper Test
- What is being tested?
- 6 minutes step test and bicycle ergometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Feb 2025to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- RA patient
- Over 18 years of age
- 100 kilos or less
- Patients who can walk independently without an assistive device
Who cannot join
- History of serious heart and lung disease
- Presence of severe musculoskeletal and joint disorders that may interfere with the conduct of the test
- Arthroplasty or major operations on knee and hip joints
- Uncontrolled hypertension
- Inability to participate in physical tests involving walking and cycling
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Firat University
Merkez, Elâzığ, 23000
Havvagül Doğan, +904242370000, havvvaguldogan@gmail.com
About this study
Official title: An Alternative Assessment in Patients with Rheumatoid Arthritis: Comparing Bicycle Ergometer and 6 Minute Step Test and Proving the Validity of the 6 Minute Step Test
Although joint involvement is predominant, RA is a systemic disease that can affect many organs. RA is a disease that includes changes such as inflammation, joint pain, fatigue, increased risk of coronary and heart disease. In patients with RA, exercises should be planned for decreased muscle strength, endurance, aerobic capacity and affected normal joint movements. Aerobic exercise capacity should be measured for individualized exercise planning in rehabilitation. Bicycle ergometer, one of the aerobic capacity tests, has been used in rehabilitation for a long time. Although it is frequently used in rehabilitation, it has some disadvantages. Therefore, other tests such as the step test can be used to eliminate these disadvantages of the bicycle ergometer and to assess functional capacity. The 6-minute step test (6MST), which requires less time and space, can be used as an alternative to assess exercise capacity. Patients will be evaluated at Firat University Hospital. Patients diagnosed with RA, older than 18 years of age and with a body weight of 100 kg or less (maximum weight supported by the stepper) will be included in the study.
Read the detailed description
Although joint involvement is predominant, RA is a systemic disease that can affect many organs. RA is a disease that includes changes such as inflammation, joint pain, fatigue, increased risk of coronary and heart disease. In patients with RA, exercises should be planned for decreased muscle strength, endurance, aerobic capacity and affected normal joint movements. Aerobic exercise capacity should be measured for individualized exercise planning in rehabilitation.The bicycle ergometer, which is one of the aerobic capacity tests, has been used in rehabilitation for a long time. Although it is frequently used in rehabilitation, it has some disadvantages. The bicycle ergometer may not always be consistent because it can vary depending on how fast the person is pedaling. It is also expensive equipment and may not be available in rehabilitation centers. In clinical settings, attention has been drawn to functional capacity tests, which can objectively assess exercise capacity, are easier to perform and do not require expensive equipment.Therefore, other tests such as the step test can be used to overcome these disadvantages of the bicycle ergometer and assess functional capacity. The 6-minute step test (6MST), which requires less time and space, can be used as an alternative to assess exercise capacity. Patients will be evaluated at Firat University Hospital. Patients diagnosed with RA, older than 18 years of age and with a body weight of 100 kg or less (maximum weight supported by the stepper) will be included in the study. Cosmed Fitmate Med, bicycle ergometer will be used. Before this test is performed, the patients' information will be entered into the device. Then a device that wraps around the patient's chest to measure HR values, a mask to measure VO2 values and a sphygmomanometer to measure blood pressure will be worn. The test will be done for as long as the patient can do it and will be finished at the patient's request. Post-test values will be recorded.
The patient will then be administered the 6MST test. This test will be performed according to the guidelines published by Borel et al. Before the test starts, the patient's heart rate, oxygen saturation, blood pressure, initial dyspnea and leg fatigue will be recorded. The stepper used can display the duration of the exercise, the number of steps per minute and the total number of steps. These values will be recorded after the test is finished. After the test, the patient's heart rate, oxygen saturation, blood pressure, dyspnea and leg fatigue will be recorded. The reliability of the 6 MST will then be decided by comparing these two test data.
- Conditions
- Rheumatoid Arthritis (RA, 6 Minutes Stepper Test
- Being tested
- 6 minutes step test and bicycle ergometer
- Keywords
- Rheumatoid arthritis, 6 minutes stepper test, Bicycle ergometer
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 minutes step test and bicycle ergometerOther
Evaluation
| Study group | Role | What they receive |
|---|---|---|
| Evaluated Group | Experimental | In this single-group study, two tests will be performed and compared. A 6-minute stepper test and a bicycle ergometer test will be applied. Receives: Other: 6 minutes step test and bicycle ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Borg Scale
The modified Borg scale is a validated scale for the subjective perception of dyspnea, used to verify the degree of respiratory distress. Exercise intensity is determined by individualized measurement. The 2002 guidelines of the American Thoracic Society recommend the modified Borg scale as an aid. This is a vertical scale measured from 0 to 10. Here 0 represents no symptoms and 10 represents maximum symptoms. In this study the modified Borg scale will be used to rate dyspnea and leg fatigue. The Borg scale will be printed out and this printout will be used for patient enumeration. The patient will be told what the numbers from 0 to 10 on the Borg scale mean. Instructions to the patient: "On the paper in your hand you see the numbers from 0 to 10. 0 means none, 10 means very severe. What the other numbers in between mean is written next to them. Now I want you to describe your breathing difficulty and leg fatigue with a number". After these instructions, the patient will be asked to n
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start18 Feb 2025 (estimated)
- Primary completion10 May 2025 (estimated)
- Study completion10 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RAStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Havvagül Doğan, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838884
- Sponsor's protocol ID
- 2024/15-25
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Alternative Assessment in Patients with Rheumatoid Arthritis: Comparing Bicycle Ergometer and 6 Minute Step Test and Proving the Validity of the 6 Minute Step Test
- ClinicalTrials.gov ID
- NCT06838884
- Acronym / sponsor ID
- 2024/15-25
- Conditions
- Rheumatoid Arthritis (RA, 6 Minutes Stepper Test
- Keywords
- Rheumatoid arthritis, 6 minutes stepper test, Bicycle ergometer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 18 Feb 2025 (estimated)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 21 Feb 2025 (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.
Although joint involvement is predominant, RA is a systemic disease that can affect many organs. RA is a disease that includes changes such as inflammation, joint pain, fatigue, increased risk of coronary and heart disease. In patients with RA, exercises should be planned for decreased muscle strength, endurance, aerobic capacity and affected normal joint movements. Aerobic exercise capacity should be measured for individualized exercise planning in rehabilitation. Bicycle ergometer, one of the aerobic capacity tests, has been used in rehabilitation for a long time. Although it is frequently used in rehabilitation, it has some disadvantages. Therefore, other tests such as the step test can be used to eliminate these disadvantages of the bicycle ergometer and to assess functional capacity. The 6-minute step test (6MST), which requires less time and space, can be used as an alternative to assess exercise capacity. Patients will be evaluated at Firat University Hospital. Patients diagnosed with RA, older than 18 years of age and with a body weight of 100 kg or less (maximum weight supported by the stepper) will be included in the study.
Detailed description
Although joint involvement is predominant, RA is a systemic disease that can affect many organs. RA is a disease that includes changes such as inflammation, joint pain, fatigue, increased risk of coronary and heart disease. In patients with RA, exercises should be planned for decreased muscle strength, endurance, aerobic capacity and affected normal joint movements. Aerobic exercise capacity should be measured for individualized exercise planning in rehabilitation.The bicycle ergometer, which is one of the aerobic capacity tests, has been used in rehabilitation for a long time. Although it is frequently used in rehabilitation, it has some disadvantages. The bicycle ergometer may not always be consistent because it can vary depending on how fast the person is pedaling. It is also expensive equipment and may not be available in rehabilitation centers. In clinical settings, attention has been drawn to functional capacity tests, which can objectively assess exercise capacity, are easier to perform and do not require expensive equipment.Therefore, other tests such as the step test can be used to overcome these disadvantages of the bicycle ergometer and assess functional capacity. The 6-minute step test (6MST), which requires less time and space, can be used as an alternative to assess exercise capacity. Patients will be evaluated at Firat University Hospital. Patients diagnosed with RA, older than 18 years of age and with a body weight of 100 kg or less (maximum weight supported by the stepper) will be included in the study. Cosmed Fitmate Med, bicycle ergometer will be used. Before this test is performed, the patients' information will be entered into the device. Then a device that wraps around the patient's chest to measure HR values, a mask to measure VO2 values and a sphygmomanometer to measure blood pressure will be worn. The test will be done for as long as the patient can do it and will be finished at the patient's request. Post-test values will be recorded.
The patient will then be administered the 6MST test. This test will be performed according to the guidelines published by Borel et al. Before the test starts, the patient's heart rate, oxygen saturation, blood pressure, initial dyspnea and leg fatigue will be recorded. The stepper used can display the duration of the exercise, the number of steps per minute and the total number of steps. These values will be recorded after the test is finished. After the test, the patient's heart rate, oxygen saturation, blood pressure, dyspnea and leg fatigue will be recorded. The reliability of the 6 MST will then be decided by comparing these two test data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluated Group | Experimental | Other: 6 minutes step test and bicycle ergometerIn this single-group study, two tests will be performed and compared. A 6-minute stepper test and a bicycle ergometer test will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- RA patient
- Over 18 years of age
- 100 kilos or less
- Patients who can walk independently without an assistive device
Key exclusion criteria (5 listed)
- History of serious heart and lung disease
- Presence of severe musculoskeletal and joint disorders that may interfere with the conduct of the test
- Arthroplasty or major operations on knee and hip joints
- Uncontrolled hypertension
- Inability to participate in physical tests involving walking and cycling
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 |
|---|---|---|
| 6 minutes step test and bicycle ergometerEvaluation | Other | Evaluated Group |
Primary outcome
Modified Borg Scale
Time frame: up to 30 minutes
The modified Borg scale is a validated scale for the subjective perception of dyspnea, used to verify the degree of respiratory distress. Exercise intensity is determined by individualized measurement. The 2002 guidelines of the American Thoracic Society recommend the modified Borg scale as an aid. This is a vertical scale measured from 0 to 10. Here 0 represents no symptoms and 10 represents maximum symptoms. In this study the modified Borg scale will be used to rate dyspnea and leg fatigue. The Borg scale will be printed out and this printout will be used for patient enumeration. The patient will be told what the numbers from 0 to 10 on the Borg scale mean. Instructions to the patient: "On the paper in your hand you see the numbers from 0 to 10. 0 means none, 10 means very severe. What the other numbers in between mean is written next to them. Now I want you to describe your breathing difficulty and leg fatigue with a number". After these instructions, the patient will be asked to n
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 minutes step test and bicycle ergometer in people with Rheumatoid Arthritis (RA and 6 Minutes Stepper Test, run by Firat 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Havvagül Doğan (+904242370000, havvvaguldogan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Borg Scale (time frame: up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2025.