AsthmaNCT07357805
Validity and Reliability of the 6-minute Stepper Test in Patients With Asthma
An observational study of Asthma, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Asthma is a chronic respiratory disease that can negatively affect exercise tolerance and functional capacity due to airway inflammation, variable airflow limitation, and symptom-related activity avoidance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jun 2017to 24 Jan 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Forty-one patients with asthma were included.
Who may be able to join
- Age > 18 years
- Diagnosis of asthma established according to the Global Initiative for Asthma (GINA) guidelines
- Use of standard asthma pharmacological treatment, including: inhaled corticosteroids (ICS), low-dose ICS in combination with long-acting β₂-agonists (LABA), or mild to high doses of ICS in combination with LABA
- Asthma Control Test (ACT) score ≥ 20
- Smoking history of ≤ 10 pack-years
Who cannot join
- Presence of a recent respiratory tract infection
- Use of systemic corticosteroids within the past year
- History of smoking
- Previous or current malignancy
- Presence of any medical condition that could affect functional exercise capacity
- Presence of any psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Sciences Department of Cardiopulmonary Physiotherapy and Rehabilitation, Ankara, Çankaya 06490
Ankara, Çankaya, 06490
About this study
Asthma is a chronic respiratory disease that can negatively affect exercise tolerance and functional capacity due to airway inflammation, variable airflow limitation, and symptom-related activity avoidance. Reduced physical activity levels and exercise-induced symptoms often lead to physical deconditioning, which may further impair cardiorespiratory fitness and daily functional performance in individuals with asthma. There is substantial evidence supporting the use of cardiopulmonary exercise testing (CPET) for the evaluation of exercise capacity in patients with respiratory diseases. However, it is not known whether the use of the 6-minute stepper test (6-MST) is a valid and reliable test for the assessment of functional exercise capacity in patients with asthma. The aim of this study is to investigate the reliability and validity of the 6-MST for evaluating functional exercise capacity in individuals with asthma.
Read the detailed description
Asthma is a chronic inflammatory disorder of the airways, characterized by variable airflow obstruction, bronchial hyperresponsiveness, and respiratory symptoms including wheezing, dyspnea, and chest tightness. Although pharmacological treatment remains the cornerstone of asthma management, the evaluation of functional capacity and exercise tolerance has become increasingly important, particularly in individuals with moderate to severe asthma.Cardiopulmonary exercise testing (CPET) is regarded as the gold standard for the comprehensive assessment of cardiovascular, ventilatory, and musculoskeletal system performance through a multidimensional approach. It provides detailed measurements of oxygen uptake (VO₂), carbon dioxide production (VCO₂), ventilatory thresholds, heart rate responses, and subjective symptoms such as dyspnea and fatigue related to musculoskeletal performance. Nevertheless, CPET requires specialized equipment and trained personnel and may not be feasible in all clinical settings, particularly for routine follow-up or in environments with limited technical resources. In contrast, the 6-minute stepper test (6-MST) has gained attention as a practical, low-cost alternative that requires minimal equipment for the assessment of functional capacity. The 6-MST consists of stepping up and down on a fixed-height platform for six minutes, with the total number of steps used as an indicator of endurance. Owing to its minimal space and equipment requirements, the test is well suited for outpatient settings, home-based rehabilitation programs, and telerehabilitation applications. However, it is not known whether the 6 MST is valid and reliable in assessing functional exercise capacity in patients with asthma. Therefore, the aim is to examine the validity and reliability of the 6 MST in patients with asthma. The study was planned as a retrospective study. All patients' clinical data, maximal exercise capacity, functional exercise capacity pulmonary function, dyspnea, and quality of life were assessed.The results will be analysed and interpreted using appropriate statistical analysis methods.
- Conditions
- Asthma
- Keywords
- Asthma, Exercise Testing, Validity and Reliability, Field Walking Test
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with asthma | All patients' clinical data, maximal exercise capacity, functional exercise capacity, pulmonary function, dyspnea, and quality of life were evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute Stepper Test
The test was performed with a stepper device positioned 20 cm above the ground. Participants were instructed to perform stepping movements as rapidly and rhythmically as possible at a self-selected pace. Standardized verbal encouragement was provided at one-minute intervals throughout the test. Participants were advised that they were permitted to pause and rest during the test if they experienced symptoms severe enough to prevent continued stepping, and that all rest periods would be included in the total test duration. Total number of step were recorded.
Measured: First day
Oxygen consumption (Cardiopulmonary Exercise Test)
Oxygen consumption was measured with Cardiopulmonary Exercise Test. The CPET was performed using a gradually increasing workload protocol with breath-by-breath measurement on a treadmill.
Measured: Second day
Secondary outcomes (8)
Pulmonary function (Forced vital capacity (FVC))
Pulmonary function testing was conducted in the upright seated position using a spirometer in accordance with the standards established by the American Thoracic Society (ATS) and the European Respiratory Society (ERS). With the device, forced vital capacity (FVC) was assessed.
Measured: First day
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Pulmonary function testing was conducted in the upright seated position using a spirometer in accordance with the standards established by the American Thoracic Society (ATS) and the European Respiratory Society (ERS). With the device, forced expiratory volume in the first second (FEV1) was assessed.
Measured: First day
Pulmonary function (FEV1 / FVC)
Pulmonary function testing was conducted in the upright seated position using a spirometer in accordance with the standards established by the American Thoracic Society (ATS) and the European Respiratory Society (ERS). With the device, FEV1 / FVC was assessed.
Measured: First day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Pulmonary function testing was conducted in the upright seated position using a spirometer in accordance with the standards established by the American Thoracic Society (ATS) and the European Respiratory Society (ERS). With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) was assessed.
Measured: First day
Pulmonary function (Peak flow rate (PEF))
Pulmonary function testing was conducted in the upright seated position using a spirometer in accordance with the standards established by the American Thoracic Society (ATS) and the European Respiratory Society (ERS). With the device, peak flow rate (PEF)) was assessed.
Measured: First day
Dyspnea (Modified Borg Scale)
The assessment of dyspnea was conducted using the Modified Borg Scale (MBS).This scale was graded between 0 (nothing at all) and 10 (very very hard). Higher score mean worse dyspnea.
Measured: First day
Dyspnea (Modified Medical Research Council Dyspnea Scale)
The assessment of dyspnea was conducted using the Modified Medical Research Council Dyspnea Scale (MMRC). The scale was graded from 0 to 4. Higher score mean worse dyspnea.
Measured: First day
Disease-specific Quality of Life
Disease-specific quality of life was assessed using the Asthma Quality of Life Questionnaire (AQLQ), which consists of 32 items across 8 sections and is scored on a 7-point Likert scale ranging from 1 to 7. The AQLQ evaluates quality of life in four disease-related domains: symptoms (12 items), activity limitations (11 items), emotional functioning (5 items), and environmental stimuli (4 items). Higher scores in each domain, as well as higher total AQLQ scores, reflect better disease-specific quality of life.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start24 Jun 2017
- Primary completion24 Jan 2019
- Study completion24 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- MERAL BOŞNAK GÜÇLÜ, Study director, Gazi UniversityNİHAN KATAYIFÇI, Study chair, Gazi UniversityFURKAN ÖZDEMİR, Principal investigator, Çankırı Karatekin UniversityUMUT ÇAĞIN ÖZCAN, Principal investigator, Bilkent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357805
- Sponsor's protocol ID
- 2025 - 1169
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grosbois JM, Riquier C, Chehere B, Coquart J, Behal H, Bart F, Wallaert B, Chenivesse C. Six-minute stepper test: a valid clinical exercise tolerance test for COPD patients. Int J Chron Obstruct Pulmon Dis. 2016 Mar 29;11:657-63. doi: 10.2147/COPD.S98635. eCollection 2016.
PubMed 27099483Marinho RS, Jurgensen SP, Arcuri JF, Goulart CL, Santos PBD, Roscani MG, Mendes RG, Oliveira CR, Caruso FR, Borghi-Silva A. Reliability and validity of six-minute step test in patients with heart failure. Braz J Med Biol Res. 2021 Jul 16;54(10):e10514. doi: 10.1590/1414-431X2020e10514. eCollection 2021.
PubMed 34287574Arcuri JF, Borghi-Silva A, Labadessa IG, Sentanin AC, Candolo C, Pires Di Lorenzo VA. Validity and Reliability of the 6-Minute Step Test in Healthy Individuals: A Cross-sectional Study. Clin J Sport Med. 2016 Jan;26(1):69-75. doi: 10.1097/JSM.0000000000000190.
PubMed 25706661American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
PubMed 12524257Borel B, Fabre C, Saison S, Bart F, Grosbois JM. An original field evaluation test for chronic obstructive pulmonary disease population: the six-minute stepper test. Clin Rehabil. 2010 Jan;24(1):82-93. doi: 10.1177/0269215509343848.
PubMed 20053721
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the 6-minute Stepper Test in Patients With Asthma
- ClinicalTrials.gov ID
- NCT07357805
- Acronym / sponsor ID
- 2025 - 1169
- Conditions
- Asthma
- Keywords
- Asthma, Exercise Testing, Validity and Reliability, Field Walking Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 24 Jun 2017 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 22 Jan 2026 (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.
Asthma is a chronic respiratory disease that can negatively affect exercise tolerance and functional capacity due to airway inflammation, variable airflow limitation, and symptom-related activity avoidance. Reduced physical activity levels and exercise-induced symptoms often lead to physical deconditioning, which may further impair cardiorespiratory fitness and daily functional performance in individuals with asthma. There is substantial evidence supporting the use of cardiopulmonary exercise testing (CPET) for the evaluation of exercise capacity in patients with respiratory diseases. However, it is not known whether the use of the 6-minute stepper test (6-MST) is a valid and reliable test for the assessment of functional exercise capacity in patients with asthma. The aim of this study is to investigate the reliability and validity of the 6-MST for evaluating functional exercise capacity in individuals with asthma.
Detailed description
Asthma is a chronic inflammatory disorder of the airways, characterized by variable airflow obstruction, bronchial hyperresponsiveness, and respiratory symptoms including wheezing, dyspnea, and chest tightness. Although pharmacological treatment remains the cornerstone of asthma management, the evaluation of functional capacity and exercise tolerance has become increasingly important, particularly in individuals with moderate to severe asthma.Cardiopulmonary exercise testing (CPET) is regarded as the gold standard for the comprehensive assessment of cardiovascular, ventilatory, and musculoskeletal system performance through a multidimensional approach. It provides detailed measurements of oxygen uptake (VO₂), carbon dioxide production (VCO₂), ventilatory thresholds, heart rate responses, and subjective symptoms such as dyspnea and fatigue related to musculoskeletal performance. Nevertheless, CPET requires specialized equipment and trained personnel and may not be feasible in all clinical settings, particularly for routine follow-up or in environments with limited technical resources. In contrast, the 6-minute stepper test (6-MST) has gained attention as a practical, low-cost alternative that requires minimal equipment for the assessment of functional capacity. The 6-MST consists of stepping up and down on a fixed-height platform for six minutes, with the total number of steps used as an indicator of endurance. Owing to its minimal space and equipment requirements, the test is well suited for outpatient settings, home-based rehabilitation programs, and telerehabilitation applications. However, it is not known whether the 6 MST is valid and reliable in assessing functional exercise capacity in patients with asthma. Therefore, the aim is to examine the validity and reliability of the 6 MST in patients with asthma. The study was planned as a retrospective study. All patients' clinical data, maximal exercise capacity, functional exercise capacity pulmonary function, dyspnea, and quality of life were assessed.The results will be analysed and interpreted using appropriate statistical analysis methods.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with asthma | – | –All patients' clinical data, maximal exercise capacity, functional exercise capacity, pulmonary function, dyspnea, and quality of life were evaluated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Forty-one patients with asthma were included.
Key inclusion criteria (5 listed)
- Age > 18 years
- Diagnosis of asthma established according to the Global Initiative for Asthma (GINA) guidelines
- Use of standard asthma pharmacological treatment, including: inhaled corticosteroids (ICS), low-dose ICS in combination with long-acting β₂-agonists (LABA), or mild to high doses of ICS in combination with LABA
- Asthma Control Test (ACT) score ≥ 20
- Smoking history of ≤ 10 pack-years
Key exclusion criteria (6 listed)
- Presence of a recent respiratory tract infection
- Use of systemic corticosteroids within the past year
- History of smoking
- Previous or current malignancy
- Presence of any medical condition that could affect functional exercise capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
6-minute Stepper Test
Time frame: First day
The test was performed with a stepper device positioned 20 cm above the ground. Participants were instructed to perform stepping movements as rapidly and rhythmically as possible at a self-selected pace. Standardized verbal encouragement was provided at one-minute intervals throughout the test. Participants were advised that they were permitted to pause and rest during the test if they experienced symptoms severe enough to prevent continued stepping, and that all rest periods would be included in the total test duration. Total number of step were recorded.
Oxygen consumption (Cardiopulmonary Exercise Test)
Time frame: Second day
Oxygen consumption was measured with Cardiopulmonary Exercise Test. The CPET was performed using a gradually increasing workload protocol with breath-by-breath measurement on a treadmill.
8 secondary outcomes
Pulmonary function (Forced vital capacity (FVC))
Time frame: First day
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Time frame: First day
Pulmonary function (FEV1 / FVC)
Time frame: First day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time frame: First day
Pulmonary function (Peak flow rate (PEF))
Time frame: First day
Dyspnea (Modified Borg Scale)
Time frame: First day
Dyspnea (Modified Medical Research Council Dyspnea Scale)
Time frame: First day
Disease-specific Quality of Life
Time frame: First day
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 23 Oct 2026.
- Results publication: PubMed 27099483Grosbois JM, Riquier C, Chehere B, Coquart J, Behal H, Bart F, Wallaert B, Chenivesse C. Six-minute stepper test: a valid clinical exercise tolerance test for COPD patients. Int J Chron Obstruct Pulmon Dis. 2016 Mar 29;11:657-63. doi: 10.2147/COPD.S98635. eCollection 2016.
- Results publication: PubMed 34287574Marinho RS, Jurgensen SP, Arcuri JF, Goulart CL, Santos PBD, Roscani MG, Mendes RG, Oliveira CR, Caruso FR, Borghi-Silva A. Reliability and validity of six-minute step test in patients with heart failure. Braz J Med Biol Res. 2021 Jul 16;54(10):e10514. doi: 10.1590/1414-431X2020e10514. eCollection 2021.
- Results publication: PubMed 25706661Arcuri JF, Borghi-Silva A, Labadessa IG, Sentanin AC, Candolo C, Pires Di Lorenzo VA. Validity and Reliability of the 6-Minute Step Test in Healthy Individuals: A Cross-sectional Study. Clin J Sport Med. 2016 Jan;26(1):69-75. doi: 10.1097/JSM.0000000000000190.
- Results publication: PubMed 12524257American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
- Results publication: PubMed 20053721Borel B, Fabre C, Saison S, Bart F, Grosbois JM. An original field evaluation test for chronic obstructive pulmonary disease population: the six-minute stepper test. Clin Rehabil. 2010 Jan;24(1):82-93. doi: 10.1177/0269215509343848.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Asthma
RecruitingObservational study
A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Asthma
RecruitingPhase 3
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
Asthma
Not yet recruitingPhase 4
Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
Asthma
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.
MERAL BOŞNAK GÜÇLÜ study director
Gazi University
NİHAN KATAYIFÇI study chair
Gazi University
FURKAN ÖZDEMİR principal investigator
Çankırı Karatekin 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 Asthma, run by Gazi 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 5 inclusion and 6 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 23 Oct 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?
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?
6-minute Stepper Test (time frame: First day). The study lists 2 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 NCT07357805, which also lists 5 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 23 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.