Use of A-STEP Test in Cystic Fibrosis Patients
- Conditions
- Cystic Fibrosis
- Interventions
- Other: step test
- Registration Number
- NCT05809492
- Lead Sponsor
- Marmara University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)< 40% step test calculation of the maximum exercise capacity using the a-step test Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)> 70% step test calculation of the maximum exercise capacity using the a-step test Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)< 40-70% step test calculation of the maximum exercise capacity using the a-step test
- Primary Outcome Measures
Name Time Method Calculation of the maximum exercise capacity using the step test in cystic fibrosis patients 18 minute Calculation of the maximum exercise capacity using the step test in cystic fibrosis patients
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mamara Üniversitesi Tıp Fakültesi
🇹🇷Istanbul, Turkey