Cystic FibrosisNCT02199340
The iStep Study: Development and Validation of an Incremental Exercise Step Test for Children With Cystic Fibrosis
A study testing iStep exercise test and CPET exercise test in people with Cystic Fibrosis, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The progression of lung disease in cystic fibrosis (CF) results inevitably in a reduction in exercise capacity. The assessment of fitness and exercise capacity in CF is an important measure of the impact of the disease process, particularly if it is repeated over time. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- iStep exercise test and CPET exercise test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Oct 2014
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical population inclusion
- Parental/guardian consent
- Participant assent
- Male or female
- Confirmed Cystic fibrosis diagnosis (by genetic genotype or positive sweat test)
- Receiving physiotherapy as part of their usual care
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- Height >125cm to allow cycle ergometer use
- 6-16 years
- Healthy control population inclusion
- Parental/guardian consent
- Participant assent
- Male or female
- 6-16 years
Who cannot join
- Clinical population exclusion
- <6 years and >16 years
- No consent / assent
- Frank haemoptysis in the last 48 hours
- Acute infective exacerbation (defined as increased temperature, additional antibiotics)
- Poor dietary intake/hydration
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- Oxygen dependent at rest
- Arterial oxygen saturation (SaO2) <90% at rest
- Burkholderia cepacia
- Coexisting insulin dependent diabetes mellitus
- Methicillin-resistant Staphylococcus aureus (MRSA) positive
- Healthy control population exclusion
- <6 years and >16 years
- No consent / assent
- Acute infection (defined as increased temperature and antibiotics)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 1EH
About this study
The progression of lung disease in cystic fibrosis (CF) results inevitably in a reduction in exercise capacity. The assessment of fitness and exercise capacity in CF is an important measure of the impact of the disease process, particularly if it is repeated over time. With recent advances in clinical management, CF lung disease in children can be relatively mild and exercise tolerance good. The currently available field tests e.g. 3 minute step test, are often completed too easily. These tests provide limited information relating to maximal exercise performance. By contrast, the maximal CardioPulmonary Exercise Test (CPET), a progressive, incremental, gold standard exercise test with breath by breath analysis of expired gas, has proved to be a valuable means of assessing exercise response in patients with CF. Its only limitation is the requirement for specialist laboratory facilities, equipment and staff.
A new field test for evaluating exercise capacity in children is needed. This should be portable, easy to administer and simple to perform by young children, while providing a higher intensity of exercise which correlates with day to day activity patterns of children, and clinically relevant information in the short term and longitudinally. This test needs to be a good surrogate measure of exercise capacity when formal CPET is unable to be undertaken. By providing accurate and useful information the results can be used to prescribe and train individuals with CF safely and effectively and can also be used in the short and long term for guidance of the medical management of these complex patients.
Read more
The aim of this study is to develop and validate the use of a new incremental step test to assess exercise tolerance/capacity in children with CF, compare this with the gold standard CPET and to provide normative healthy control comparison data The main objectives of the study are
- To develop an incremental step test to assess exercise tolerance / capacity in children with CF.
- To compare the incremental step test with the gold standard CPET
- To assess the level of exercise response produced by the incremental step test
- To assess the correlation between independent variables of lung function measurements, age, weight and height with VO2peak and other exercise test outcomes
- To assess the repeatability and evaluate the normal variability of the new incremental step test
- To provide healthy control normative data for comparison
- Conditions
- Cystic Fibrosis
- Being tested
- iStep exercise test, CPET exercise test
- Keywords
- Exercise testing, Children, Exercise capacity
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStep exercise testOther
newly developed submaximal exercise test
CPET exercise testOther
maximal gold standard exercise test
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis | Experimental | * iStep exercise test
* CPET exercise test Receives: Other: iStep exercise test; Other: CPET exercise test |
| Healthy control | Active comparator | - iStep exercise test Receives: Other: iStep exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake (VO2peak)
Gold standard exercise test to determine peak oxygen uptake during exercise
Measured: Measured during the exercise test, day 1, maximum of 20 minutes
Secondary outcomes (4)
Secondary breath by breath analysis outcome measures
Measured: Measured during the exercise test, day 1, maximum of 20 minutes
Newly developed iStep exercise test outcome variables
Standard field exercise test outcomes of heart rate, oxygen saturations, time, level achieved, rate of perceived exertion, perceived breathlessness
Measured: Measured during the exercise test, day 1, maximum of 20 minutes
Height, weight and body mass index measures
Height, weight and body mass index will be measured for descriptive purposes only
Measured: Measured at baseline on the day of testing, day 1, maximum of 5 minutes
Reasons for termination of the incremental step test
Measured: Measured at the end of the exercise test, day 1, maximum of 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startJul 2011
- Primary completionOct 2014
- Study completionOct 2014
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.
- 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
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Rand, BA, BSc, MSc, Principal investigator, UCL Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199340
- Sponsor's protocol ID
- 11AR14
- Status last verified
- Apr 2016
- First submitted
- 12 Jun 2014
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The iStep Study: Development and Validation of an Incremental Exercise Step Test for Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02199340
- Acronym / sponsor ID
- 11AR14
- Conditions
- Cystic Fibrosis
- Keywords
- Exercise testing, Children, Exercise capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Jul 2014 (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.
The progression of lung disease in cystic fibrosis (CF) results inevitably in a reduction in exercise capacity. The assessment of fitness and exercise capacity in CF is an important measure of the impact of the disease process, particularly if it is repeated over time. With recent advances in clinical management, CF lung disease in children can be relatively mild and exercise tolerance good. The currently available field tests e.g. 3 minute step test, are often completed too easily. These tests provide limited information relating to maximal exercise performance. By contrast, the maximal CardioPulmonary Exercise Test (CPET), a progressive, incremental, gold standard exercise test with breath by breath analysis of expired gas, has proved to be a valuable means of assessing exercise response in patients with CF. Its only limitation is the requirement for specialist laboratory facilities, equipment and staff.
A new field test for evaluating exercise capacity in children is needed. This should be portable, easy to administer and simple to perform by young children, while providing a higher intensity of exercise which correlates with day to day activity patterns of children, and clinically relevant information in the short term and longitudinally. This test needs to be a good surrogate measure of exercise capacity when formal CPET is unable to be undertaken. By providing accurate and useful information the results can be used to prescribe and train individuals with CF safely and effectively and can also be used in the short and long term for guidance of the medical management of these complex patients.
The aim of this study is to develop and validate the use of a new incremental step test to assess exercise tolerance/capacity in children with CF, compare this with the gold standard CPET and to provide normative healthy control comparison data The main objectives of the study are
- To develop an incremental step test to assess exercise tolerance / capacity in children with CF.
- To compare the incremental step test with the gold standard CPET
- To assess the level of exercise response produced by the incremental step test
- To assess the correlation between independent variables of lung function measurements, age, weight and height with VO2peak and other exercise test outcomes
- To assess the repeatability and evaluate the normal variability of the new incremental step test
- To provide healthy control normative data for comparison
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis | Experimental | Other: iStep exercise test, Other: CPET exercise test* iStep exercise test * CPET exercise test |
| Healthy control | Active comparator | Other: iStep exercise test- iStep exercise test |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Clinical population inclusion
- Parental/guardian consent
- Participant assent
- Male or female
- Confirmed Cystic fibrosis diagnosis (by genetic genotype or positive sweat test)
Key exclusion criteria (15 listed)
- Clinical population exclusion
- <6 years and >16 years
- No consent / assent
- Frank haemoptysis in the last 48 hours
- Acute infective exacerbation (defined as increased temperature, additional antibiotics)
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 |
|---|---|---|
| iStep exercise testnewly developed submaximal exercise test | Other | Cystic fibrosis, Healthy control |
| CPET exercise testmaximal gold standard exercise test | Other | Cystic fibrosis |
Primary outcome
Peak oxygen uptake (VO2peak)
Time frame: Measured during the exercise test, day 1, maximum of 20 minutes
Gold standard exercise test to determine peak oxygen uptake during exercise
4 secondary outcomes
Secondary breath by breath analysis outcome measures
Time frame: Measured during the exercise test, day 1, maximum of 20 minutes
Newly developed iStep exercise test outcome variables
Time frame: Measured during the exercise test, day 1, maximum of 20 minutes
Height, weight and body mass index measures
Time frame: Measured at baseline on the day of testing, day 1, maximum of 5 minutes
Reasons for termination of the incremental step test
Time frame: Measured at the end of the exercise test, day 1, maximum of 5 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 19 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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.
Sarah Rand, BA, BSc, MSc principal investigator
UCL Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iStep exercise test and CPET exercise test in people with Cystic Fibrosis, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
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 13 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 19 Apr 2016. 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 United Kingdom. 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?
Peak oxygen uptake (VO2peak) (time frame: Measured during the exercise test, day 1, maximum of 20 minutes). 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 19 Apr 2016.