Status:
COMPLETED
The iStep Study: Development and Validation of an Incremental Exercise Step Test for Children With Cystic Fibrosis
Lead Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-16 years
Phase:
NA
Brief 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 imp...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02199340
Start Date
July 1 2011
End Date
October 1 2014
Last Update
April 19 2016
Active Locations (1)
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1
Great Ormond Street Hospital for Children NHS Foundation Trust
London, United Kingdom, WC1N 1EH