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NCT Number: NCT07193173

Is the Two-minute Step Test an Alternative to the Six-minute Walk Test in Pulmonary Hypertension?

The aim of this observational study is to evaluate the validity of the 2-minute step test in assessing functional capacity in pulmonary hypertension.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University - Cerrahpasa

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being diagnosed with pulmonary hypertension (PH)
  • Being 18 years of age or older
  • Agreeing to participate in the study

Exclusion criteria

  • Acute decompensated heart failure
  • Orthopedic or neurological disorders that prevent the test from being performed
  • Patients who have difficulty understanding the instructions given

Treatment and study plan

2 minute step test

Other

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Functional capacity

    Time frame: 6 minutes

    The 6-minute walk test will be performed.

  2. mMRC Dyspnea Scale

    Time frame: 5 minutes

    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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Is the Two-minute Step Test an Alternative to the Six-minute Walk Test in Pulmonary Hypertension?: Validation of 2 Minute Step Test

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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