Cystic FibrosisNCT05809492
Use of A-STEP Test in Cystic Fibrosis Patients
A study testing step test in people with Cystic Fibrosis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- step test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Having evidence of febrile illness
- Hemoptysis
- Uncontrolled asthma
- Pneumothorax
- Cardiac, vascular and renal comorbidities
- Pulmonary hypertension
Show all 10Show fewer
- CF-related diabetes
- Body mass index <18 kg/m2
- Pregnancy
- Inability to follow instructions safely
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mamara Üniversitesi Tıp Fakültesi
Istanbul
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- step test
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
step testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)< 40% | Experimental | calculation of the maximum exercise capacity using the a-step test Receives: Other: step test |
| Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)< 40-70% | Experimental | calculation of the maximum exercise capacity using the a-step test Receives: Other: step test |
| Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)> 70% | Experimental | calculation of the maximum exercise capacity using the a-step test Receives: Other: step test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Jan 2023
- Primary completion1 Feb 2023
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809492
- Sponsor's protocol ID
- MAR.FTR.AD2
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of A-STEP Test in Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT05809492
- Acronym / sponsor ID
- MAR.FTR.AD2
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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%.
| Arm | Type | Receives |
|---|---|---|
| Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)< 40% | Experimental | Other: step testcalculation of the maximum exercise capacity using the a-step test |
| Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)< 40-70% | Experimental | Other: step testcalculation of the maximum exercise capacity using the a-step test |
| Patients with a diagnosis of cystic fibrosis, FEV1(functional expiratory volume)> 70% | Experimental | Other: step testcalculation of the maximum exercise capacity using the a-step test |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- Having evidence of febrile illness
- Hemoptysis
- Uncontrolled asthma
- Pneumothorax
- Cardiac, vascular and renal comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| step testThe 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. | Other | 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% |
Primary outcome
Calculation of the maximum exercise capacity using the step test in cystic fibrosis patients
Time frame: 18 minute
Calculation of the maximum exercise capacity using the step test in cystic fibrosis patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing step test in people with Cystic Fibrosis, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özge Keniş Coşkun, MD (05058294947, Ozgekenis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of the maximum exercise capacity using the step test in cystic fibrosis patients (time frame: 18 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.