Systemic Sclerosis (SSc)NCT06859567
Chester Step Test: is It Effective in Scleroderma Patients?
A study testing Evaluation in people with Systemic Sclerosis (SSc) and Chester Step Test, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
Systemic sclerosis (SSC) is a chronic autoimmune disease in which autoimmune features are associated with vascular manifestations. Patients with SSC experience many problems such as interstitial lung disease (ILD), pulmonary arterial hypertension (PAH), heart failure, severe gastrointestinal tract (GIT) involvement… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis (SSc), Chester Step Test, 6 Minutes Walk Test
- What is being tested?
- Evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2025to 15 Jul 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
- Over 18 years old
- Patients who can walk independently without an assistive device
Who cannot join
- Chronic obstructive pulmonary disease
- Myocardial infarction history
- Congestive heart failure
- Serious or unstable illness that may limit exercise tolerance
- Presence of severe musculoskeletal and joint disorders that may interfere with the conduct of the test
- Inability to perform the simplest level of the Chester step test
Show all 9Show fewer
- Arthroplasty or major operations on knee and hip joints
- Uncontrolled hypertension
- Lack of ability to understand and implement all recommended procedures
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
Firat University
Merkez, Elâzığ, 23000
Havvagül Doğan, +90 424 2370000, havvvaguldogan@gmail.com
About this study
Official title: Proving the Efficacy of the Chester Step Test in Scleroderma Patients Compared with the 6-Minute Walk Test
Systemic sclerosis (SSC) is a chronic autoimmune disease in which autoimmune features are associated with vascular manifestations. Patients with SSC experience many problems such as interstitial lung disease (ILD), pulmonary arterial hypertension (PAH), heart failure, severe gastrointestinal tract (GIT) involvement and scleroderma renal crisis (SRC). Because of these problems, SSC patients may develop an abnormal pulmonary hemodynamic response during exercise. In this situation, measuring the aerobic capacity of SSC patients can be a useful tool for health promotion. There are many different methods for measuring aerobic capacity tests. The most commonly used aerobic capacity test in SSC patients is the 6-minute walk test (6 MWT). However, although the 6 MWT is a commonly used test, it has some disadvantages. Because SSC affects multiple organs, there are doubts about the 6 MWT's ability to accurately assess these diseases. These disadvantages of the 6MWT have led to the search for new tests. The Chester step test (CST) is a submaximal test and a good option to assess aerobic capacity. An adapted version of the CST for non-healthy individuals can be used to assess aerobic capacity. There are some studies conducted with CST. As a result of my research, no study evaluating CST in individuals with SSC was found.
Read the detailed description
Systemic sclerosis (SSC) is a chronic autoimmune disease with autoimmune features combined with vascular manifestations. Systemic sclerosis (SSC), the main symptom of which is skin sclerosis, is a marker that can detect the activity of the disease. Apart from skin involvement, SSC affects many internal organs such as the musculoskeletal system, gastrointestinal system, lungs, heart and kidneys. Because of these problems, SSC patients may develop an abnormal pulmonary hemodynamic response during exercise. This can lead to symptoms of dyspnea, fatigue and decreased exercise tolerance. In this situation, measuring the aerobic capacity of SSC patients can be a useful tool in health promotion. There are many different methods for measuring aerobic capacity tests. The most commonly used aerobic capacity test in SSC patients is the 6-minute walk test (6 MWT). However, although the 6 MWT is a commonly used test, it has some disadvantages. Because SSC affects multiple organs, there are doubts about the 6 MWT's ability to accurately assess these diseases. For an accurate 6MWT assessment, a 30 meter corridor is needed. This length of corridor is impossible to access in some clinics. These disadvantages of the 6MWT have led to the search for new tests. The Chester step test (CST) is a submaximal test and a good option for assessing aerobic capacity. Compared to 6 MWT, CST has the advantage of requiring portable equipment. It is a cost-effective option to assess exercise tolerance, fatigue and dyspnea. Because of these advantages of the CST, it can be used to assess aerobic capacity when adapted to non-healthy individuals. There are some studies conducted with CST. As a result of my research, no study evaluating CST in individuals with SSC was found. The study will be conducted at Firat University Hospital and 45 patients will be evaluated. After the demographic data of the patients included in the study are recorded, 6MWT will be performed and the results will be recorded. Then CST will be performed and the results will be recorded.6 Dyspnea, fatigue and leg fatigue will be evaluated with the Modified Borg Scale before and after MWT and CST. The patient's heart rate, oxygen saturation and blood pressure will be recorded before and after the tests. In addition, the patient's heart rate and oxygen saturation will be recorded after each level passed in CST.
- Being tested
- Evaluation
- Keywords
- Chester step test, Systemic Sclerosis, 6 minutes walk test, Modified Borg Scale
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
Comparison of the 6-minute walk test and Chester step test, one of the aerobic capacity tests
| Study group | Role | What they receive |
|---|---|---|
| Evaluated Group | Active comparator | 6 minute walk test, Chester step test Receives: Other: Evaluation |
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 subjective perception of dyspnea used with the 6MWT to confirm 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 adjunct to the 6MWT. This scale 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. After instructions have been given, the patient will be asked to rate dyspnea and leg fatigue before and after the test and the numbers will be recorded.
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 posted5 Mar 2025
- Study start11 Mar 2025 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies 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
- 45 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
- NCT06859567
- Sponsor's protocol ID
- 2025/03-16
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proving the Efficacy of the Chester Step Test in Scleroderma Patients Compared with the 6-Minute Walk Test
- ClinicalTrials.gov ID
- NCT06859567
- Acronym / sponsor ID
- 2025/03-16
- Keywords
- Chester step test, Systemic Sclerosis, 6 minutes walk test, Modified Borg Scale
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 11 Mar 2025 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 5 Mar 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.
Systemic sclerosis (SSC) is a chronic autoimmune disease in which autoimmune features are associated with vascular manifestations. Patients with SSC experience many problems such as interstitial lung disease (ILD), pulmonary arterial hypertension (PAH), heart failure, severe gastrointestinal tract (GIT) involvement and scleroderma renal crisis (SRC). Because of these problems, SSC patients may develop an abnormal pulmonary hemodynamic response during exercise. In this situation, measuring the aerobic capacity of SSC patients can be a useful tool for health promotion. There are many different methods for measuring aerobic capacity tests. The most commonly used aerobic capacity test in SSC patients is the 6-minute walk test (6 MWT). However, although the 6 MWT is a commonly used test, it has some disadvantages. Because SSC affects multiple organs, there are doubts about the 6 MWT's ability to accurately assess these diseases. These disadvantages of the 6MWT have led to the search for new tests. The Chester step test (CST) is a submaximal test and a good option to assess aerobic capacity. An adapted version of the CST for non-healthy individuals can be used to assess aerobic capacity. There are some studies conducted with CST. As a result of my research, no study evaluating CST in individuals with SSC was found.
Detailed description
Systemic sclerosis (SSC) is a chronic autoimmune disease with autoimmune features combined with vascular manifestations. Systemic sclerosis (SSC), the main symptom of which is skin sclerosis, is a marker that can detect the activity of the disease. Apart from skin involvement, SSC affects many internal organs such as the musculoskeletal system, gastrointestinal system, lungs, heart and kidneys. Because of these problems, SSC patients may develop an abnormal pulmonary hemodynamic response during exercise. This can lead to symptoms of dyspnea, fatigue and decreased exercise tolerance. In this situation, measuring the aerobic capacity of SSC patients can be a useful tool in health promotion. There are many different methods for measuring aerobic capacity tests. The most commonly used aerobic capacity test in SSC patients is the 6-minute walk test (6 MWT). However, although the 6 MWT is a commonly used test, it has some disadvantages. Because SSC affects multiple organs, there are doubts about the 6 MWT's ability to accurately assess these diseases. For an accurate 6MWT assessment, a 30 meter corridor is needed. This length of corridor is impossible to access in some clinics. These disadvantages of the 6MWT have led to the search for new tests. The Chester step test (CST) is a submaximal test and a good option for assessing aerobic capacity. Compared to 6 MWT, CST has the advantage of requiring portable equipment. It is a cost-effective option to assess exercise tolerance, fatigue and dyspnea. Because of these advantages of the CST, it can be used to assess aerobic capacity when adapted to non-healthy individuals. There are some studies conducted with CST. As a result of my research, no study evaluating CST in individuals with SSC was found. The study will be conducted at Firat University Hospital and 45 patients will be evaluated. After the demographic data of the patients included in the study are recorded, 6MWT will be performed and the results will be recorded. Then CST will be performed and the results will be recorded.6 Dyspnea, fatigue and leg fatigue will be evaluated with the Modified Borg Scale before and after MWT and CST. The patient's heart rate, oxygen saturation and blood pressure will be recorded before and after the tests. In addition, the patient's heart rate and oxygen saturation will be recorded after each level passed in CST.
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 | Active comparator | Other: Evaluation6 minute walk test, Chester step test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 years old
- Patients who can walk independently without an assistive device
Key exclusion criteria (9 listed)
- Chronic obstructive pulmonary disease
- Myocardial infarction history
- Congestive heart failure
- Serious or unstable illness that may limit exercise tolerance
- Presence of severe musculoskeletal and joint disorders that may interfere with the conduct of the test
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 |
|---|---|---|
| EvaluationComparison of the 6-minute walk test and Chester step test, one of the aerobic capacity tests | Other | Evaluated Group |
Primary outcome
Modified Borg Scale
Time frame: up to 30 minutes
The modified Borg scale is a validated scale for subjective perception of dyspnea used with the 6MWT to confirm 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 adjunct to the 6MWT. This scale 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. After instructions have been given, the patient will be asked to rate dyspnea and leg fatigue before and after the test and the numbers will be recorded.
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 5 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation in people with Systemic Sclerosis (SSc) and Chester Step 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 2 inclusion and 9 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: opening soon, as of the sponsor's last update on 5 Mar 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 (+90 4242370000, 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 5 Mar 2025.