Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2023-01-01
2024-02-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)< 40%
calculation of the maximum exercise capacity using the a-step test
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.
Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)< 40-70%
calculation of the maximum exercise capacity using the a-step test
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.
Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)> 70%
calculation of the maximum exercise capacity using the a-step test
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
65 Years
ALL
No
Sponsors
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Marmara University
OTHER
Responsible Party
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Locations
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Mamara Üniversitesi Tıp Fakültesi
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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MAR.FTR.AD2
Identifier Type: -
Identifier Source: org_study_id
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