Pulmonary HypertensionNCT07193173
Is the Two-minute Step Test an Alternative to the Six-minute Walk Test in Pulmonary Hypertension?
An observational study of Pulmonary Hypertension, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to evaluate the validity of the 2-minute step test in assessing functional capacity in pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- 2 minute step test
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 25 Jun 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
Study population: Patients being diagnosed with pulmonary hypertension (PH)
Who may be able to join
- Being diagnosed with pulmonary hypertension (PH)
- Being 18 years of age or older
- Agreeing to participate in the study
Who cannot join
- Acute decompensated heart failure
- Orthopedic or neurological disorders that prevent the test from being performed
- Patients who have difficulty understanding the instructions given
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Two-minute Step Test an Alternative to the Six-minute Walk Test in Pulmonary Hypertension?: Validation of 2 Minute Step Test
The aim of this observational study is to evaluate the validity of the 2-minute step test in assessing functional capacity in pulmonary hypertension.
Read the detailed description
Pulmonary hypertension (PH) is a progressive cardiopulmonary disorder characterized by elevated pulmonary artery pressure, which can lead to right ventricular dysfunction and ultimately heart failure. Right heart catheterization is used to diagnose the disease, and individuals are diagnosed with PH when the mean pulmonary artery pressure is 20 mmHg or higher. Exercise intolerance is one of the key features of PH. The 6-minute walk test (6MWT) is the most commonly used test method in PH centers for assessing functional exercise capacity and plays a key role in the evaluation and management of PH. However, it has significant limitations in this context. Although the 6MWT is currently recommended for assessing functional exercise capacity independently of the environment, it is not feasible in most clinics, homes, and medical offices due to the requirement for a 30-meter-long corridor. The long-standing need for a practical and effective exercise assessment tool that is independent of physical space highlights the need for new methods to assess functional capacity. The 2-minute walk test was developed by Rikli and Jones in 1999.
The test requires individuals to stand and step in place as quickly as possible for 2 minutes while raising their knees to a height between the patella and iliac crest. Performance in the test is defined as the number of steps taken on the right side within 2 minutes, reaching the criterion height. The validity and reliability of the 2-minute step test have previously been investigated in patients with back pain, cardiopulmonary rehabilitation patients, and hypertensive geriatric patients.
The aim of this study is to evaluate the validity of the 2-minute step test in assessing functional capacity in PH.
- Conditions
- Pulmonary Hypertension
- Being tested
- 2 minute step test
- Keywords
- Pulmonary Hypertension, 2 minute step test, 6 minute walk test, validation
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 minute step testOther
The 2-Minute Step Test (2MST) is a simple, validated field test used to assess aerobic endurance and functional fitness, especially in older adults or people with chronic conditions (e.g., cardiopulmonary disease, neurological disorders).
What is being measured
The primary outcome is the main question the study is designed to answer.
2 Minute Step Test
The 2-minute step test (2MST) is a test used to assess functional capacity. The maximum number of knee lifts the individual can perform within 2 minutes will be counted, with the minimum height occurring at the midpoint between the patella and the anterior superior iliac spine (during steady walking, without changing position). The test will be performed with a mobile ergospirometer (K5, Cosmed, Italy). Oxygen consumption, task-based heart rate, and ventilation obtained during the 2MST will be recorded. In addition, the Borg dyspnea and fatigue scale will also be included in the assessment.
Measured: 2 minutes
Secondary outcomes (2)
Functional capacity
The 6-minute walk test will be performed.
Measured: 6 minutes
mMRC Dyspnea Scale
This scale is a five-item scale (0: no dyspnea, 4 severe dyspnea) based on various physical activities that cause the feeling of dyspnea. Here, patients are asked to mark the level of activity that causes dyspnea.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start15 Sep 2025
- Primary completion15 Jun 2026 (estimated)
- Study completion25 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar BASTURK MERC, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193173
- Sponsor's protocol ID
- 2460
- Status last verified
- May 2026
- First submitted
- 17 Sep 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sharing of this information is restricted by the ethics committee and informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Two-minute Step Test an Alternative to the Six-minute Walk Test in Pulmonary Hypertension?: Validation of 2 Minute Step Test
- ClinicalTrials.gov ID
- NCT07193173
- Acronym / sponsor ID
- 2460
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, 2 minute step test, 6 minute walk test, validation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 25 Jun 2026 (estimated)
- First posted
- 25 Sep 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.
The aim of this observational study is to evaluate the validity of the 2-minute step test in assessing functional capacity in pulmonary hypertension.
Detailed description
Pulmonary hypertension (PH) is a progressive cardiopulmonary disorder characterized by elevated pulmonary artery pressure, which can lead to right ventricular dysfunction and ultimately heart failure. Right heart catheterization is used to diagnose the disease, and individuals are diagnosed with PH when the mean pulmonary artery pressure is 20 mmHg or higher. Exercise intolerance is one of the key features of PH. The 6-minute walk test (6MWT) is the most commonly used test method in PH centers for assessing functional exercise capacity and plays a key role in the evaluation and management of PH. However, it has significant limitations in this context. Although the 6MWT is currently recommended for assessing functional exercise capacity independently of the environment, it is not feasible in most clinics, homes, and medical offices due to the requirement for a 30-meter-long corridor. The long-standing need for a practical and effective exercise assessment tool that is independent of physical space highlights the need for new methods to assess functional capacity. The 2-minute walk test was developed by Rikli and Jones in 1999.
The test requires individuals to stand and step in place as quickly as possible for 2 minutes while raising their knees to a height between the patella and iliac crest. Performance in the test is defined as the number of steps taken on the right side within 2 minutes, reaching the criterion height. The validity and reliability of the 2-minute step test have previously been investigated in patients with back pain, cardiopulmonary rehabilitation patients, and hypertensive geriatric patients.
The aim of this study is to evaluate the validity of the 2-minute step test in assessing functional capacity in PH.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being diagnosed with pulmonary hypertension (PH)
Key inclusion criteria (3 listed)
- Being diagnosed with pulmonary hypertension (PH)
- Being 18 years of age or older
- Agreeing to participate in the study
Key exclusion criteria (3 listed)
- Acute decompensated heart failure
- Orthopedic or neurological disorders that prevent the test from being performed
- Patients who have difficulty understanding the instructions given
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 2-Minute Step Test (2MST) is a simple, validated field test used to assess aerobic endurance and functional fitness, especially in older adults or people with chronic conditions (e.g., cardiopulmonary disease, neurological disorders). | Other | – |
Primary outcome
2 Minute Step Test
Time frame: 2 minutes
The 2-minute step test (2MST) is a test used to assess functional capacity. The maximum number of knee lifts the individual can perform within 2 minutes will be counted, with the minimum height occurring at the midpoint between the patella and the anterior superior iliac spine (during steady walking, without changing position). The test will be performed with a mobile ergospirometer (K5, Cosmed, Italy). Oxygen consumption, task-based heart rate, and ventilation obtained during the 2MST will be recorded. In addition, the Borg dyspnea and fatigue scale will also be included in the assessment.
2 secondary outcomes
Functional capacity
Time frame: 6 minutes
mMRC Dyspnea Scale
Time frame: 5 minutes
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 7 May 2026.
- Individual participant dataSharing planned: No. The sharing of this information is restricted by the ethics committee and informed consent form.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pulmonary Hypertension, run by Saglik Bilimleri Universitesi 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. 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?
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?
2 Minute Step Test (time frame: 2 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 7 May 2026.