Clinical trial NCT05809492: Use of A-STEP Test in Cystic Fibrosis Patients
Official title: Use of A-STEP Test in Cystic Fibrosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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%.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Calculation of the maximum exercise capacity using the step test in cystic fibrosis patients
timeFrame: 18 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Mamara Üniversitesi Tıp Fakültesi
Study officials:
References: