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

Recruiting

• Conditions: Pulmonary Hypertension

• Registration Number: NCT07193173
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief 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.

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 Timeline

• Study Start: 2025-09-15
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-17
• Study First Posted: 2025-09-25
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-01
• Last Update Posted: 2025-10-02
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2 Minute Step Test	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 Outcome Measures

Name	Time	Method
Functional capacity	6 minutes	The 6-minute walk test will be performed.
mMRC Dyspnea Scale	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.

Trial Locations

Locations (1)

Istanbul University - Cerrahpasa; Istanbul, Turkey (Türkiye)