Status:
COMPLETED
INSPIRE-CF: an Alternative Physiotherapy Model for Children With Cystic Fibrosis
Lead Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-15 years
Phase:
NA
Brief Summary
The primary aim of the research is to evaluate whether an alternative model of cystic fibrosis (CF) physiotherapy care can produce statistically significant improvements in clinical and patient report...
Eligibility Criteria
Inclusion
- Patients with a documented diagnosis of Cystic Fibrosis;
- Male or female aged 6 years or older at baseline and \<17years old at the end of the 2-year study;
- Currently under the primary care of the GOSH CF Unit;
- Able to perform Spirometry with a baseline FEV1 percentage predicted of 40% or higher, as measured on at least 3 occasions in the previous year, during times of clinical stability (i.e. not during an exacerbation, and not during or within 2 weeks of intravenous antibiotics);
- The participant's parent or legal guardian must be able to give informed consent; assent will be sought from all children.
Exclusion
- Patients who have had lung transplantation;
- Patients listed for lung transplantation;
- Clinically significant disease or medical condition other than CF or CF-related conditions that in the opinion of the multi-disciplinary clinical team, would compromise the safety of the patient;
- Orthopaedic impairment that compromises exercise performance;
- Mental impairment leading to inability to cooperate;
- Unable to understand both verbal and/or written instructions English. Children will need to be able to understand exactly what the physiotherapists are instructing them do, for safe and effective exercise training sessions. Information sheets and questionnaires are only available in English;
- Participants, parents or legal guardians who are unwilling to sign consent to participate in the study.
- The following criteria will not exclude a child from participating in the study, but based on the hospital's exercise laboratory's infection control protocol, may preclude the participant from Cardiopulmonary Exercise Testing.
- Patients with Methicillin-Resistant Staphylococcus Aureus;
- Patients with Burkholderia Cepacia.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01889927
Start Date
May 1 2012
End Date
December 31 2017
Last Update
September 6 2019
Active Locations (1)
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1
Great Ormond Street Hospital for Children NHS Foundation Trust
London, United Kingdom, WC1N 3JH