Cystic FibrosisA-STEPNCT02717650
The Alfred Step Test Exercise Protocol (A-STEP), for Adults With Cystic Fibrosis.
A study testing A-STEP, A-STEP (New Protocol) and Comparator: CPET cycle ergometer (Gold Standard) in people with Cystic Fibrosis and Fibrosis, run by The Alfred at 1 site in Australia.
Trial summary
Exercise testing has become clinically important in the management and ongoing evaluation of patients with Cystic Fibrosis (CF) with higher rates of exercise tolerance and participation previously linked to lower mortality risk (1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Fibrosis, Lung Diseases
- What is being tested?
- A-STEP, A-STEP (New Protocol) and Comparator: CPET cycle ergometer (Gold Standard)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Aug 2016to 4 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed Diagnosis of CF (by genotype or positive sweat test)
- Aged 18yrs and older
- FEV1 ≥20% (Forced expiration in 1 sec)
- Stable baseline state. (Stable baseline state is defined as: clinically stable respiratory status, for at least 30 days, characterized by the absence of hospitalization and no changes in maintenance therapy during this period (Yankaskas et al 2004)).
Who cannot join
- Febrile
- Haemoptysis
- Uncontrolled asthma
- Pneumothorax
- Cardiac issues
- Unreliable readings on pulse oximetry
Show all 15Show fewer
- Pulmonary hypertension
- Unstable CF related diabetes (CFRD)
- Vascular issues
- Renal disease
- Pregnancy
- Body mass index (BMI) <18.0
- Significant musculoskeletal issues
- Unable to safely follow instructions
- (ATS/ACCP 2003; Hebestreit 2015)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development; Feasibility/Safety and Validation of the Alfred Step Test Exercise Protocol (A-STEP) Developed for Adults With Cystic Fibrosis:
Exercise testing has become clinically important in the management and ongoing evaluation of patients with Cystic Fibrosis (CF) with higher rates of exercise tolerance and participation previously linked to lower mortality risk (1).
Lower exercise capacity generally correlates with more severe lung disease (2,3) and landmark studies suggest that low exercise capacity as measured by peak oxygen capacity (VO2peak) and rate of decline in lung function (FEV1) are strong predictors of mortality (1,4). However not all studies have found pulmonary function tests (PFTs) to be reliable predictors of maximal exercise capacity (5), especially in relatively well preserved lung function (6,7).
Read more
The wide distribution in physical capacity between fit individuals and end stage disease adds to complexity of assessment. Independent factors of age, genetics, habitual exercise, nutritional status and musculoskeletal conditions are all known to influence physical capacity in patients with CF (8,9).
Maximal exercise testing places additional stress on cardiovascular, respiratory and peripheral systems providing more information around multiple influences on disease progression including degree of limitation in these major systems (10,11) and is useful for assessment of exercise desaturation, more common (but not always present) in advanced lung disease (5,12).
With prediction of exercise performance and functional capacity from PFTs unreliable and the understanding that health status correlates better with exercise tolerance there has been an increase in maximal exercise testing for patient management (13). Many international centers now regard exercise testing as highly important with many assessing maximal exercise capacity annually to monitor disease progression, identify physical status and drive changes in medical, physiotherapy or nutritional management (14,15).
The main vision is to develop a standardized incremental step test protocol suitable for adults with Cystic Fibrosis (CF), all ages, levels of fitness and disease state that is in line with current exercise testing recommendations (15). To develop a more useful field test to assess exercise tolerance and a more "user friendly" test than the currently available laboratory exercise test to allow for early detection of decline in physical function in the day-to-day clinical setting. To date no studies have been published in adults with CF where an incremental exercise step test has been investigated to assess exercise tolerance or determine maximum oxygen uptake (VO2max).
Read the detailed description
Many international centers now regard exercise testing as highly important with many measuring maximal exercise capacity annually to monitor disease progression, identify physical status and to drive changes in medical, physiotherapy or nutritional management (14,15).
Cardiopulmonary Exercise Testing (CPET):
The current best practice for assessing VO2max in adults with CF is a CPET using the Godfrey Protocol, a progressive and incremental maximal test performed on a cycle ergometer (13,14,15). Exercise testing should aim to achieve a maximal response within a time frame of 8-12 min and incremental protocols with stage duration of 1 minute are considered more efficient in eliciting the desired response within this time frame (14). During CPET, VO2max is determined while breath-by-breath gas analysis allows for a comprehensive assessment of exercise ventilation and circulation. This information can identify reasons for low exercise capacity and whether exercise limitation is due to deconditioning, or primarily within the respiratory, cardiovascular or peripheral systems. CPET is performed using a specialist ergometer, and requires specialist clinical expertise, monitoring and reporting equipment for interpretation of the test. The cost, space and expertise to carry out CPET in CF units around the world may limit its use for the regular assessment of exercise capacity in adults with CF (16).
Field Tests:
Field tests generally cannot determine absolute maximal exercise capacity, but do provide valuable information about the patient's functional abilities and limitations and compared to laboratory tests are inexpensive and easy to administer.
Field tests that use a single step for assessment of exercise tolerance in patients with chronic lung disease include:
3-Minute Step Test (3MST):
The 3MST is a feasible and acceptable measure of sub-maximal exercise performance in children and adults and a useful tool in the assessment of oxygen desaturation (17,18). The test is short in duration, simple to carry out, and has low cost and minimal space and equipment requirements however the sub-maximal nature and ceiling effect of the 3MST limits its usefulness clinically across the age spectrum (18,19).
The Chester Step Test (CST):
The CST is a 10-minute sub-maximal standardized multistage test and like the 3MST has minimal space and equipment requirements. The CST was originally designed for workplace screening and is now widely used for exercise prescription in the UK cardiac population (20). In healthy individuals one study reported a ceiling effect and a positive relationship between predicted VO2max using the CST and measured VO2max (21) however a subsequent study questioned this prediction validity (22). The CST has been found to be highly reproducible in patients with chronic obstructive lung disease (COPD) and reliable in patients with Bronchiectasis, but too challenging for both groups (23,24).
The Modified Incremental Step Test (MIST):
The MIST was designed to be more suitable for COPD patients and modeled from the CST(25). A reduction in work rate was not found to result in a difference in cardiopulmonary stress and exertion effort at peak exercise but did result in a higher exercise tolerance in patients with COPD. The MIST is reliable and better tolerated than the CST in patients with Bronchiectasis (23,24).
The CST and CF:
One study (published in abstract form) has shown the CST to be a useful field test when compared to the 3MST and 6MWT for those with mild to moderate CF. The authors commented this was likely due to the progressive nature being more representative of adult physical activity (26).
The main vision is to develop a standardized incremental step test protocol suitable for adults with Cystic Fibrosis (CF), all ages, levels of fitness and disease state that is in line with current exercise testing recommendations (15). The test should be a more useful than the already available field tests and more "user friendly" test than the currently available laboratory exercise test to assess exercise tolerance and allow for early detection of decline in physical function in the day-to-day clinical setting. To date no studies have been published in adults with CF where an incremental exercise step test has been investigated to assess exercise tolerance or determine VO2max.
- To design a standardized externally paced incremental step test that is portable, easy to administer, simple to perform, time, cost and space efficient (A-STEP). Study A:
- To assess feasibility and reliability of the A-STEP to objectively assess exercise tolerance.
- To determine if the A-STEP is a more useful tool than the 3-Minute Step Test. Study B:
- To develop an alternative tool to determine maximum oxygen uptake (VO2max) to the "gold standard" CPET that is feasible across the whole spectrum of lung disease.
- To determine if the A-STEPmax is a valid tool when compared to the VO2max achieved from a CPET performed on a cycle ergometer using the Godfrey Protocol.
The principle investigator hypothesizes that the A-STEP will be a feasible tool to assess exercise capacity; and the A-STEP max will be a valid tool for the assessment of VO2max across the age range and disease spectrum in adults with CF.
- Conditions
- Cystic Fibrosis, Fibrosis, Lung Diseases, Respiratory Diseases, Genetic Diseases, Pancreatic Diseases
- Being tested
- A-STEP, A-STEP (New Protocol), Comparator: CPET cycle ergometer (Gold Standard)
- Keywords
- Exercise Testing, Maximal Exercise Testing, Maximal Exercise Capacity, Peak Exercise Capacity, Adults, Step Tests
- Medical subject headings
- Cystic Fibrosis, Fibrosis, Lung Diseases, Respiratory Tract Diseases, Genetic Diseases, Inborn, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-STEPOther
Also called Alfred Step Test Exercise Protocol (A-STEP)
Study A) Study A) Development of new exercise test protocol and Observational Feasibility/Safety Study (no comparator).
Feasibility/safety of a newly designed, incremental, maximal, standardised step test in adults with Cystic Fibrosis.
A-STEP (New Protocol)Other
Also called Alfred Step Test Exercise Protocol
Study B) Validation Study (random allocation of test order). Validity of an incremental, maximal, standardised incremental step test with breath-by-breath gas analysis using portable metabolic measurement equipment against CPET.
Comparator: CPET cycle ergometer (Gold Standard)Other
Also called Cardiopulmonary Exercise Test Protocol
Study B) Validation study (random allocation of test order) "Gold standard" CPET. An incremental, maximal standardised cycle ergometer exercise test (performed as per published protocol) using portable metabolic measurement equipment.
| Study group | Role | What they receive |
|---|---|---|
| A-STEP | Experimental | Study A) A-STEP Study Development of new exercise test protocol and Observational Feasibility/Safety Study (no comparator). Receives: Other: A-STEP |
| A-STEP (New Protocol) | Experimental | Study B) A-STEPmax Study Validity Study (random allocation of test order). Receives: Other: A-STEP (New Protocol) |
| CPET cycle ergometer (Gold Standard) | Active comparator | Study B) A-STEPmax Study Validity Study (random allocation of test order). Receives: Other: Comparator: CPET cycle ergometer (Gold Standard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study B) Maximum oxygen uptake (VO2max)
The highest oxygen uptake achieved during the exercise test taken from inspired gas in a given period of time. Body weight is used to calculate this from oxygen consumption during the test. VO2peak may be used as a surrogate if VO2max is not achieved. Criteria for reaching maximum effort is not included in this document.
Measured: Measured during the incremental test for a maximum of 15 minutes.
Study A) Oxygen Saturation
Standard objective outcome measures of field exercise testing. Measured via pulse oximetry.
Measured: Measured for 3 min prior to exercise (recorded at baseline sitting and standing), monitored during the test (recorded at minute intervals) and for at least 2 min of recovery up to a maximum of 10 minutes.
Study A) Heart Rate
Standard objective outcome measures of field exercise testing. Measured via pulse oximetry.
Measured: Measures for 3 min prior to exercise (recorded at baseline sitting and standing), monitored during the test (recorded at minute intervals) and for at least 2 min of recovery up to a maximum of 10 minutes.
Secondary outcomes (11)
Study B) Carbon Dioxide Production
Standard secondary outcome measure of maximal exercise testing using breath- by-breath gas analysis with portable metabolic measurement equipment.
Measured: Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.
Study B) Respiratory Exchange Ratio
Standard secondary outcome measure of maximal exercise testing using breath- by-breath gas analysis. The ratio of carbon dioxide production to oxygen consumption.
Measured: Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.
Study B) Minute Ventilation
Standard secondary outcome measure of maximal exercise testing using breath- by-breath gas analysis. The product of tidal volume and respiratory rate.
Measured: Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.
Study B) Oxygen Pulse
Standard secondary outcome measure of maximal exercise testing using breath- by-breath gas analysis. Calculated by dividing the oxygen consumption by heart rate.
Measured: Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.
Study B) Tidal Volume
Standard secondary outcome measure of maximal exercise testing using breath- by-breath gas analysis. The volume of each breath taken.
Measured: Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.
Study B) Oxygen Saturation
Standard objective outcome measures of exercise testing. Measured via pulse oximetry.
Measured: easures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery
Study B) Heart rate
Standard objective outcome measures of exercise testing. Measured via pulse oximetry.
Measured: easures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery
Study B) Measures from Electrocardiogram
Used to monitor the patient's cardiac rhythm (CPET only)
Measured: easures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery
Study A & B) Breathlessness and Leg Fatigue
Standard subjective outcome measures of exercise testing. Modified Borg 0-10.
Measured: Measures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery
Study A & B) Blood pressure
Standard outcome measure of exercise testing.
Measured: Measures are takenpre/post A-STEP, pre/every 2 mins during/post CPET
Study A & B) Duration of test; Highest level (mins and sec)/stage achieved; Reason for test termination.
Parameters of exercise test.
Measured: Measured during or on completion of the test. Maximum 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start25 Aug 2016
- Primary completion4 Mar 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Principal investigator, Lisa Wilson, The Alfred
- Investigators
- Lisa M Wilson, BHS(Physio), Principal investigator, Alfred Hospital; Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717650
- Sponsor's protocol ID
- 205/16
- Other IDs
- 205/16, 0267
- Acronym
- A-STEP
- Status last verified
- Aug 2025
- First submitted
- 10 Mar 2016
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share individual patient data.
Publications
Nixon PA, Orenstein DM, Kelsey SF, Doershuk CF. The prognostic value of exercise testing in patients with cystic fibrosis. N Engl J Med. 1992 Dec 17;327(25):1785-8. doi: 10.1056/NEJM199212173272504.
PubMed 1435933Godfrey S, Mearns M. Pulmonary function and response to exercise in cystic fibrosis. Arch Dis Child. 1971 Apr;46(246):144-51. doi: 10.1136/adc.46.246.144.
PubMed 5576246Marcotte JE, Grisdale RK, Levison H, Coates AL, Canny GJ. Multiple factors limit exercise capacity in cystic fibrosis. Pediatr Pulmonol. 1986 Sep-Oct;2(5):274-81. doi: 10.1002/ppul.1950020505.
PubMed 3774384Pianosi P, Leblanc J, Almudevar A. Peak oxygen uptake and mortality in children with cystic fibrosis. Thorax. 2005 Jan;60(1):50-4. doi: 10.1136/thx.2003.008102.
PubMed 15618583Henke KG, Orenstein DM. Oxygen saturation during exercise in cystic fibrosis. Am Rev Respir Dis. 1984 May;129(5):708-11. doi: 10.1164/arrd.1984.129.5.708.
PubMed 6426354Moorcroft AJ, Dodd ME, Webb AK. Exercise testing and prognosis in adult cystic fibrosis. Thorax. 1997 Mar;52(3):291-3. doi: 10.1136/thx.52.3.291.
PubMed 9093351Shah AR, Gozal D, Keens TG. Determinants of aerobic and anaerobic exercise performance in cystic fibrosis. Am J Respir Crit Care Med. 1998 Apr;157(4 Pt 1):1145-50. doi: 10.1164/ajrccm.157.4.9705023.
PubMed 9563732Lands LC, Heigenhauser GJ, Jones NL. Respiratory and peripheral muscle function in cystic fibrosis. Am Rev Respir Dis. 1993 Apr;147(4):865-9. doi: 10.1164/ajrccm/147.4.865.
PubMed 8466121Nixon PA, Orenstein DM, Kelsey SF. Habitual physical activity in children and adolescents with cystic fibrosis. Med Sci Sports Exerc. 2001 Jan;33(1):30-5. doi: 10.1097/00005768-200101000-00006.
PubMed 11194108Barry SC, Gallagher CG. Corticosteroids and skeletal muscle function in cystic fibrosis. J Appl Physiol (1985). 2003 Oct;95(4):1379-84. doi: 10.1152/japplphysiol.00506.2002. Epub 2003 Jun 13.
PubMed 12807896Urquhart DS. Exercise testing in cystic fibrosis: why (and how)? J R Soc Med. 2011 Jul;104 Suppl 1(Suppl 1):S6-14. doi: 10.1258/jrsm.2011.s11102. No abstract available.
PubMed 21719895Rogers D, Prasad SA, Doull I. Exercise testing in children with cystic fibrosis. J R Soc Med. 2003;96 Suppl 43(Suppl 43):23-9. No abstract available.
PubMed 12906322American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
PubMed 12524257Balady GJ, Arena R, Sietsema K, Myers J, Coke L, Fletcher GF, Forman D, Franklin B, Guazzi M, Gulati M, Keteyian SJ, Lavie CJ, Macko R, Mancini D, Milani RV; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Interdisciplinary Council on Quality of Care and Outcomes Research. Clinician's Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 13;122(2):191-225. doi: 10.1161/CIR.0b013e3181e52e69. Epub 2010 Jun 28. No abstract available.
PubMed 20585013Hebestreit H, Arets HGM, Aurora P, Boas S, Cerny F, Hulzebos EHJ, Karila C, Lands LC, Lowman JD, Swisher A, Urquhart DS; European Cystic Fibrosis Exercise Working Group. Statement on Exercise Testing in Cystic Fibrosis. Respiration. 2015;90(4):332-351. doi: 10.1159/000439057. Epub 2015 Sep 9.
PubMed 26352941
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development; Feasibility/Safety and Validation of the Alfred Step Test Exercise Protocol (A-STEP) Developed for Adults With Cystic Fibrosis:
- ClinicalTrials.gov ID
- NCT02717650
- Acronym / sponsor ID
- A-STEP / 205/16
- Conditions
- Cystic Fibrosis, Fibrosis, Lung Diseases, Respiratory Diseases, Genetic Diseases, Pancreatic Diseases
- Keywords
- Exercise Testing, Maximal Exercise Testing, Maximal Exercise Capacity, Peak Exercise Capacity, Adults, Step Tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Collaborators
- Monash University
- Study start
- 25 Aug 2016 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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.
Exercise testing has become clinically important in the management and ongoing evaluation of patients with Cystic Fibrosis (CF) with higher rates of exercise tolerance and participation previously linked to lower mortality risk (1).
Lower exercise capacity generally correlates with more severe lung disease (2,3) and landmark studies suggest that low exercise capacity as measured by peak oxygen capacity (VO2peak) and rate of decline in lung function (FEV1) are strong predictors of mortality (1,4). However not all studies have found pulmonary function tests (PFTs) to be reliable predictors of maximal exercise capacity (5), especially in relatively well preserved lung function (6,7).
The wide distribution in physical capacity between fit individuals and end stage disease adds to complexity of assessment. Independent factors of age, genetics, habitual exercise, nutritional status and musculoskeletal conditions are all known to influence physical capacity in patients with CF (8,9).
Maximal exercise testing places additional stress on cardiovascular, respiratory and peripheral systems providing more information around multiple influences on disease progression including degree of limitation in these major systems (10,11) and is useful for assessment of exercise desaturation, more common (but not always present) in advanced lung disease (5,12).
With prediction of exercise performance and functional capacity from PFTs unreliable and the understanding that health status correlates better with exercise tolerance there has been an increase in maximal exercise testing for patient management (13). Many international centers now regard exercise testing as highly important with many assessing maximal exercise capacity annually to monitor disease progression, identify physical status and drive changes in medical, physiotherapy or nutritional management (14,15).
The main vision is to develop a standardized incremental step test protocol suitable for adults with Cystic Fibrosis (CF), all ages, levels of fitness and disease state that is in line with current exercise testing recommendations (15). To develop a more useful field test to assess exercise tolerance and a more "user friendly" test than the currently available laboratory exercise test to allow for early detection of decline in physical function in the day-to-day clinical setting. To date no studies have been published in adults with CF where an incremental exercise step test has been investigated to assess exercise tolerance or determine maximum oxygen uptake (VO2max).
Detailed description
Many international centers now regard exercise testing as highly important with many measuring maximal exercise capacity annually to monitor disease progression, identify physical status and to drive changes in medical, physiotherapy or nutritional management (14,15).
Cardiopulmonary Exercise Testing (CPET):
The current best practice for assessing VO2max in adults with CF is a CPET using the Godfrey Protocol, a progressive and incremental maximal test performed on a cycle ergometer (13,14,15). Exercise testing should aim to achieve a maximal response within a time frame of 8-12 min and incremental protocols with stage duration of 1 minute are considered more efficient in eliciting the desired response within this time frame (14). During CPET, VO2max is determined while breath-by-breath gas analysis allows for a comprehensive assessment of exercise ventilation and circulation. This information can identify reasons for low exercise capacity and whether exercise limitation is due to deconditioning, or primarily within the respiratory, cardiovascular or peripheral systems. CPET is performed using a specialist ergometer, and requires specialist clinical expertise, monitoring and reporting equipment for interpretation of the test. The cost, space and expertise to carry out CPET in CF units around the world may limit its use for the regular assessment of exercise capacity in adults with CF (16).
Field Tests:
Field tests generally cannot determine absolute maximal exercise capacity, but do provide valuable information about the patient's functional abilities and limitations and compared to laboratory tests are inexpensive and easy to administer.
Field tests that use a single step for assessment of exercise tolerance in patients with chronic lung disease include:
3-Minute Step Test (3MST):
The 3MST is a feasible and acceptable measure of sub-maximal exercise performance in children and adults and a useful tool in the assessment of oxygen desaturation (17,18). The test is short in duration, simple to carry out, and has low cost and minimal space and equipment requirements however the sub-maximal nature and ceiling effect of the 3MST limits its usefulness clinically across the age spectrum (18,19).
The Chester Step Test (CST):
The CST is a 10-minute sub-maximal standardized multistage test and like the 3MST has minimal space and equipment requirements. The CST was originally designed for workplace screening and is now widely used for exercise prescription in the UK cardiac population (20). In healthy individuals one study reported a ceiling effect and a positive relationship between predicted VO2max using the CST and measured VO2max (21) however a subsequent study questioned this prediction validity (22). The CST has been found to be highly reproducible in patients with chronic obstructive lung disease (COPD) and reliable in patients with Bronchiectasis, but too challenging for both groups (23,24).
The Modified Incremental Step Test (MIST):
The MIST was designed to be more suitable for COPD patients and modeled from the CST(25). A reduction in work rate was not found to result in a difference in cardiopulmonary stress and exertion effort at peak exercise but did result in a higher exercise tolerance in patients with COPD. The MIST is reliable and better tolerated than the CST in patients with Bronchiectasis (23,24).
The CST and CF:
One study (published in abstract form) has shown the CST to be a useful field test when compared to the 3MST and 6MWT for those with mild to moderate CF. The authors commented this was likely due to the progressive nature being more representative of adult physical activity (26).
The main vision is to develop a standardized incremental step test protocol suitable for adults with Cystic Fibrosis (CF), all ages, levels of fitness and disease state that is in line with current exercise testing recommendations (15). The test should be a more useful than the already available field tests and more "user friendly" test than the currently available laboratory exercise test to assess exercise tolerance and allow for early detection of decline in physical function in the day-to-day clinical setting. To date no studies have been published in adults with CF where an incremental exercise step test has been investigated to assess exercise tolerance or determine VO2max.
- To design a standardized externally paced incremental step test that is portable, easy to administer, simple to perform, time, cost and space efficient (A-STEP). Study A:
- To assess feasibility and reliability of the A-STEP to objectively assess exercise tolerance.
- To determine if the A-STEP is a more useful tool than the 3-Minute Step Test. Study B:
- To develop an alternative tool to determine maximum oxygen uptake (VO2max) to the "gold standard" CPET that is feasible across the whole spectrum of lung disease.
- To determine if the A-STEPmax is a valid tool when compared to the VO2max achieved from a CPET performed on a cycle ergometer using the Godfrey Protocol.
The principle investigator hypothesizes that the A-STEP will be a feasible tool to assess exercise capacity; and the A-STEP max will be a valid tool for the assessment of VO2max across the age range and disease spectrum in adults with CF.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A-STEP | Experimental | Other: A-STEPStudy A) A-STEP Study Development of new exercise test protocol and Observational Feasibility/Safety Study (no comparator). |
| A-STEP (New Protocol) | Experimental | Other: A-STEP (New Protocol)Study B) A-STEPmax Study Validity Study (random allocation of test order). |
| CPET cycle ergometer (Gold Standard) | Active comparator | Other: Comparator: CPET cycle ergometer (Gold Standard)Study B) A-STEPmax Study Validity Study (random allocation of test order). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed Diagnosis of CF (by genotype or positive sweat test)
- Aged 18yrs and older
- FEV1 ≥20% (Forced expiration in 1 sec)
- Stable baseline state. (Stable baseline state is defined as: clinically stable respiratory status, for at least 30 days, characterized by the absence of hospitalization and no changes in maintenance therapy during this period (Yankaskas et al 2004)).
Key exclusion criteria (15 listed)
- Febrile
- Haemoptysis
- Uncontrolled asthma
- Pneumothorax
- Cardiac issues
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 |
|---|---|---|
| A-STEPAlso: Alfred Step Test Exercise Protocol (A-STEP)Study A) Study A) Development of new exercise test protocol and Observational Feasibility/Safety Study (no comparator). Feasibility/safety of a newly designed, incremental, maximal, standardised step test in adults with Cystic Fibrosis. | Other | A-STEP |
| A-STEP (New Protocol)Also: Alfred Step Test Exercise ProtocolStudy B) Validation Study (random allocation of test order). Validity of an incremental, maximal, standardised incremental step test with breath-by-breath gas analysis using portable metabolic measurement equipment against CPET. | Other | A-STEP (New Protocol) |
| Comparator: CPET cycle ergometer (Gold Standard)Also: Cardiopulmonary Exercise Test ProtocolStudy B) Validation study (random allocation of test order) "Gold standard" CPET. An incremental, maximal standardised cycle ergometer exercise test (performed as per published protocol) using portable metabolic measurement equipment. | Other | CPET cycle ergometer (Gold Standard) |
Primary outcome
Study B) Maximum oxygen uptake (VO2max)
Time frame: Measured during the incremental test for a maximum of 15 minutes.
The highest oxygen uptake achieved during the exercise test taken from inspired gas in a given period of time. Body weight is used to calculate this from oxygen consumption during the test. VO2peak may be used as a surrogate if VO2max is not achieved. Criteria for reaching maximum effort is not included in this document.
Study A) Oxygen Saturation
Time frame: Measured for 3 min prior to exercise (recorded at baseline sitting and standing), monitored during the test (recorded at minute intervals) and for at least 2 min of recovery up to a maximum of 10 minutes.
Standard objective outcome measures of field exercise testing. Measured via pulse oximetry.
Study A) Heart Rate
Time frame: Measures for 3 min prior to exercise (recorded at baseline sitting and standing), monitored during the test (recorded at minute intervals) and for at least 2 min of recovery up to a maximum of 10 minutes.
Standard objective outcome measures of field exercise testing. Measured via pulse oximetry.
11 secondary outcomes
Study B) Carbon Dioxide Production
Time frame: Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.
Study B) Respiratory Exchange Ratio
Time frame: Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.
Study B) Minute Ventilation
Time frame: Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.
Study B) Oxygen Pulse
Time frame: Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.
Study B) Tidal Volume
Time frame: Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.
Study B) Oxygen Saturation
Time frame: easures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery
Study B) Heart rate
Time frame: easures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery
Study B) Measures from Electrocardiogram
Time frame: easures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery
Study A & B) Breathlessness and Leg Fatigue
Time frame: Measures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery
Study A & B) Blood pressure
Time frame: Measures are takenpre/post A-STEP, pre/every 2 mins during/post CPET
Study A & B) Duration of test; Highest level (mins and sec)/stage achieved; Reason for test termination.
Time frame: Measured during or on completion of the test. Maximum 15 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 1435933Nixon PA, Orenstein DM, Kelsey SF, Doershuk CF. The prognostic value of exercise testing in patients with cystic fibrosis. N Engl J Med. 1992 Dec 17;327(25):1785-8. doi: 10.1056/NEJM199212173272504.
- Background: PubMed 5576246Godfrey S, Mearns M. Pulmonary function and response to exercise in cystic fibrosis. Arch Dis Child. 1971 Apr;46(246):144-51. doi: 10.1136/adc.46.246.144.
- Background: PubMed 3774384Marcotte JE, Grisdale RK, Levison H, Coates AL, Canny GJ. Multiple factors limit exercise capacity in cystic fibrosis. Pediatr Pulmonol. 1986 Sep-Oct;2(5):274-81. doi: 10.1002/ppul.1950020505.
- Background: PubMed 15618583Pianosi P, Leblanc J, Almudevar A. Peak oxygen uptake and mortality in children with cystic fibrosis. Thorax. 2005 Jan;60(1):50-4. doi: 10.1136/thx.2003.008102.
- Background: PubMed 6426354Henke KG, Orenstein DM. Oxygen saturation during exercise in cystic fibrosis. Am Rev Respir Dis. 1984 May;129(5):708-11. doi: 10.1164/arrd.1984.129.5.708.
- Background: PubMed 9093351Moorcroft AJ, Dodd ME, Webb AK. Exercise testing and prognosis in adult cystic fibrosis. Thorax. 1997 Mar;52(3):291-3. doi: 10.1136/thx.52.3.291.
- Background: PubMed 9563732Shah AR, Gozal D, Keens TG. Determinants of aerobic and anaerobic exercise performance in cystic fibrosis. Am J Respir Crit Care Med. 1998 Apr;157(4 Pt 1):1145-50. doi: 10.1164/ajrccm.157.4.9705023.
- Background: PubMed 8466121Lands LC, Heigenhauser GJ, Jones NL. Respiratory and peripheral muscle function in cystic fibrosis. Am Rev Respir Dis. 1993 Apr;147(4):865-9. doi: 10.1164/ajrccm/147.4.865.
- Background: PubMed 11194108Nixon PA, Orenstein DM, Kelsey SF. Habitual physical activity in children and adolescents with cystic fibrosis. Med Sci Sports Exerc. 2001 Jan;33(1):30-5. doi: 10.1097/00005768-200101000-00006.
- Background: PubMed 12807896Barry SC, Gallagher CG. Corticosteroids and skeletal muscle function in cystic fibrosis. J Appl Physiol (1985). 2003 Oct;95(4):1379-84. doi: 10.1152/japplphysiol.00506.2002. Epub 2003 Jun 13.
- Background: PubMed 21719895Urquhart DS. Exercise testing in cystic fibrosis: why (and how)? J R Soc Med. 2011 Jul;104 Suppl 1(Suppl 1):S6-14. doi: 10.1258/jrsm.2011.s11102. No abstract available.
- Background: PubMed 12906322Rogers D, Prasad SA, Doull I. Exercise testing in children with cystic fibrosis. J R Soc Med. 2003;96 Suppl 43(Suppl 43):23-9. No abstract available.
- Individual participant dataSharing planned: No. No plan to share individual patient data.
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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.
Lisa M Wilson, BHS(Physio) principal investigator
Alfred Hospital; Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-STEP, A-STEP (New Protocol) and Comparator: CPET cycle ergometer (Gold Standard) in people with Cystic Fibrosis and Fibrosis, run by The Alfred at 1 site in Australia.
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 4 inclusion and 15 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: finished, as of the sponsor's last update on 11 Aug 2025. 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 Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study B) Maximum oxygen uptake (VO2max) (time frame: Measured during the incremental test for a maximum of 15 minutes.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02717650, which also lists 27 linked publications.
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 11 Aug 2025.