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Use of A-STEP Test in Cystic Fibrosis Patients

Primary Purpose

Cystic Fibrosis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
step test
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cystic Fibrosis

Eligibility Criteria

10 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mamara Üniversitesi Tıp FakültesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)< 40%

Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)< 40-70%

Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)> 70%

Arm Description

calculation of the maximum exercise capacity using the a-step test

calculation of the maximum exercise capacity using the a-step test

calculation of the maximum exercise capacity using the a-step test

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 30, 2023
Last Updated
March 30, 2023
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05809492
Brief Title
Use of A-STEP Test in Cystic Fibrosis Patients
Official Title
Use of A-STEP Test in Cystic Fibrosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients between the ages of 18-50 with a diagnosis of cystic fibrosis FEV1 >70%, FEV1 40-70% and FEV1 <40% who are clinically stable are patients with cystic fibrosis Deciency FEV1 >70%, FEV1 <40%.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)< 40%
Arm Type
Experimental
Arm Description
calculation of the maximum exercise capacity using the a-step test
Arm Title
Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)< 40-70%
Arm Type
Experimental
Arm Description
calculation of the maximum exercise capacity using the a-step test
Arm Title
Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)> 70%
Arm Type
Experimental
Arm Description
calculation of the maximum exercise capacity using the a-step test
Intervention Type
Other
Intervention Name(s)
step test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Calculation of the maximum exercise capacity using the step test in cystic fibrosis patients
Description
Calculation of the maximum exercise capacity using the step test in cystic fibrosis patients
Time Frame
18 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Özge Keniş Coşkun, MD
Phone
05058294947
Email
Ozgekenis@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Burak Yıldız, Dr.
Phone
05546797417
Email
adaletli_26@hotmail.com
Facility Information:
Facility Name
Mamara Üniversitesi Tıp Fakültesi
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of A-STEP Test in Cystic Fibrosis Patients

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