NCT07357805

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2019

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

December 23, 2025

Last Update Submit

January 30, 2026

Conditions

Keywords

AsthmaExercise TestingValidity and ReliabilityField Walking Test

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Second day

Secondary Outcomes (8)

  • Pulmonary function (Forced vital capacity (FVC))

    First day

  • Pulmonary function (Forced expiratory volume in the first second (FEV1))

    First day

  • Pulmonary function (FEV1 / FVC)

    First day

  • Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

    First day

  • Pulmonary function (Peak flow rate (PEF))

    First day

  • +3 more secondary outcomes

Study Arms (1)

Patients with asthma

All patients' clinical data, maximal exercise capacity, functional exercise capacity, pulmonary function, dyspnea, and quality of life were evaluated.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Forty-one patients with asthma were included.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Health Sciences Department of Cardiopulmonary Physiotherapy and Rehabilitation, Ankara, Çankaya 06490

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

  • Marinho 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.

  • Arcuri 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.

  • American 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.

  • Borel 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.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • MERAL BOŞNAK GÜÇLÜ

    Gazi University

    STUDY DIRECTOR
  • NİHAN KATAYIFÇI

    Gazi University

    STUDY CHAIR
  • FURKAN ÖZDEMİR

    Çankırı Karatekin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 22, 2026

Study Start

June 24, 2017

Primary Completion

January 24, 2019

Study Completion

January 24, 2019

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations