NCT05809492

Use of A-STEP Test in Cystic Fibrosis Patients

Status unknown NA Last updated 12 April 2023

What this trial tests

NA trial testing step test in Cystic Fibrosis in 10 participants. Status unknown.

Timeline

1 January 2023

Primary endpoint
1 February 2023

1 February 2024

Quick facts

Lead sponsor	Marmara University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	10
Start date	1 January 2023
Primary completion	1 February 2023
Estimated completion	1 February 2024
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• step test

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

Marmara University

Who can join

Adults 10 to 65, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The exercise test provides prognostic information about clinical outcomes and quality of life to optimize care for cystic fibrosis patients (pwCF). The exercise test identifies the causes of exercise restriction, adverse exercise reactions, and exercise-related symptoms. The results help to determine and evaluate the impact of exercise programs at PWCF. Peak oxygen uptake (VO2peak) is a prognostic measure of maximum exercise capacity that usually worsens as CF lung disease progresses.

The recommended gold standard exercise test at PWCF is a cardiopulmonary exercise test (CPET) performed on a loop ergometer to assess VO2peak and cardiopulmonary responses to exercise. the recommended incremental protocol, consisting of 1-minute phases, should reach VO2peak within 8-12 minutes. Trained operators perform cpets with complex and expensive laboratory equipment, and it is inaccessible and little used by many people internationally.

Step tests are low-cost, portable, easily standardized and require minimal space to perform. The 3-Minute Step Test (3MST) is an externally paced test for the assessment of exercise tolerance set at 30 steps/minute for 3 minutes. In adults with CF, 3MST is useful for assessing oxygen desaturation and predicting future increased use of healthcare services. Limitations include the ceiling effect in less severe CF lung disease, and it is very difficult for some with more advanced lung disease.

An incremental maximum A-STEP step test has been developed to assess exercise capacity in the CF lung disease December, without floor or ceiling effects, within clinical space constraints and the need for strict infection prevention.

A-STEP is a new incremental maximum step test to assess exercise capacity in PWCF without floor or ceiling effects, as an alternative field test to CPET.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Validity and Reliability of the Turkish Version of the AWESCORE Test.
   Yıldız B, Keniş-Coşkun Ö, Kızıltepe T, Karadağ-Saygı E, et al · · 2025 · PMID 40091631 · DOI 10.5152/turkarchpediatr.2025.24199