Use of A-STEP Test in Cystic Fibrosis Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: step test

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Özge Keniş Coşkun, MD; Phone Number: 05058294947; Email: Ozgekenis@gmail.com
• Study Contact Backup: Name: Burak Yıldız, Dr.; Phone Number: 05546797417; Email: adaletli_26@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Mamara Üniversitesi Tıp Fakültesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• having been diagnosed with cystic fibrosis between the ages of 18 and 50 Dec
• FEV 1 value must be at least 20%
• Being clinically stable (no hospitalization for at least 30 days, no history of acute exacerbations, no changes in maintenance therapy)

Exclusion Criteria:

• Having evidence of febrile illness
• Hemoptysis
• Uncontrolled asthma
• Pneumothorax
• Cardiac, vascular and renal comorbidities
• Pulmonary hypertension
• CF-related diabetes
• Body mass index <18 kg/m2
• Pregnancy
• Inability to follow instructions safely

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)< 40%; calculation of the maximum exercise capacity using the a-step test	Other: step test; The step speed of 18 steps/min was chosen for the first level because it is suitable for all subjects and prevents them from being too fast at the end of the test. the slow standardized initial tempo at Level 1 of 72 beats/min allowed familiarity with the coordinated cascading technology of the tests (step up and down in time with the metronome beat). Regular replacement of the leading leg was encouraged to prevent unilateral leg fatigue and November muscle pain. pwCF selected 1-minute stage times for each level in accordance with the maximum exercise test (CPET) recommendations in 18; at each new level, the test speed was increased by two steps / minute to ensure a progressive change in exercise parameters; a suitable end test time of 16 minutes was achieved along with an initial speed of 18 steps/min. The fast pace of 194 beats/min (48 steps/min at Level 16), which was eventually reached, it was physically possible to perform safely.
Experimental: Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)< 40-70%; calculation of the maximum exercise capacity using the a-step test	Other: step test; The step speed of 18 steps/min was chosen for the first level because it is suitable for all subjects and prevents them from being too fast at the end of the test. the slow standardized initial tempo at Level 1 of 72 beats/min allowed familiarity with the coordinated cascading technology of the tests (step up and down in time with the metronome beat). Regular replacement of the leading leg was encouraged to prevent unilateral leg fatigue and November muscle pain. pwCF selected 1-minute stage times for each level in accordance with the maximum exercise test (CPET) recommendations in 18; at each new level, the test speed was increased by two steps / minute to ensure a progressive change in exercise parameters; a suitable end test time of 16 minutes was achieved along with an initial speed of 18 steps/min. The fast pace of 194 beats/min (48 steps/min at Level 16), which was eventually reached, it was physically possible to perform safely.
Experimental: Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)> 70%; calculation of the maximum exercise capacity using the a-step test	Other: step test; The step speed of 18 steps/min was chosen for the first level because it is suitable for all subjects and prevents them from being too fast at the end of the test. the slow standardized initial tempo at Level 1 of 72 beats/min allowed familiarity with the coordinated cascading technology of the tests (step up and down in time with the metronome beat). Regular replacement of the leading leg was encouraged to prevent unilateral leg fatigue and November muscle pain. pwCF selected 1-minute stage times for each level in accordance with the maximum exercise test (CPET) recommendations in 18; at each new level, the test speed was increased by two steps / minute to ensure a progressive change in exercise parameters; a suitable end test time of 16 minutes was achieved along with an initial speed of 18 steps/min. The fast pace of 194 beats/min (48 steps/min at Level 16), which was eventually reached, it was physically possible to perform safely.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculation of the maximum exercise capacity using the step test in cystic fibrosis patients	Calculation of the maximum exercise capacity using the step test in cystic fibrosis patients	18 minute

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): February 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: MAR.FTR.AD2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No