NCT07193173

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
0mo left

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Sep 2025Jun 2026

Study Start

First participant enrolled

September 15, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2026

Expected
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

September 17, 2025

Last Update Submit

May 6, 2026

Conditions

Keywords

Pulmonary Hypertension2 minute step test6 minute walk testvalidation

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 minutes

Secondary Outcomes (2)

  • Functional capacity

    6 minutes

  • mMRC Dyspnea Scale

    5 minutes

Interventions

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).

Eligibility Criteria

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

Patients being diagnosed with pulmonary hypertension (PH)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Physiotherapist, PhD

Study Record Dates

First Submitted

September 17, 2025

First Posted

September 25, 2025

Study Start

September 15, 2025

Primary Completion

June 15, 2026

Study Completion (Estimated)

June 25, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

The sharing of this information is restricted by the ethics committee and informed consent form.

Locations