INSPIRE-CF: an Alternative Physiotherapy Model for Children With Cystic Fibrosis (INSPIRE-CF)
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|ClinicalTrials.gov Identifier: NCT01889927|
Recruitment Status : Completed
First Posted : July 1, 2013
Last Update Posted : September 6, 2019
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 reported outcomes, and whether this alternative model is economically advantageous and/or sustainable.
Children randomised to the control group will receive 24-months of current model of CF care at Great Ormond Street Hospital (GOSH).
Children randomised to the intervention group will receive 24-months of current model of CF care at GOSH PLUS a weekly structured, individually prescribed and personally supervised exercise intervention at a local fitness facility or at school. The exercise prescription will include aerobic, anaerobic, strength, core conditioning and stretching components.
The main objectives of the study are:
- Determine differences, if any, in lung function between the two groups;
- Determine differences, if any, in exercise capacity between the two groups;
- Evaluate cost of care of alternate model of care versus current model of care.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Other: Exercise Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||INSPIRE-CF: A Randomised Controlled Trial Investigating the Clinical and Economic Benefits of an Alternative Model of Physiotherapy Care for Children With Cystic Fibrosis|
|Actual Study Start Date :||May 1, 2012|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||December 31, 2017|
No Intervention: Group 1: Control
Control Group (Arm 1): Children randomised to the control group will receive 24-months of current model of specialist CF care.
Active Comparator: Group 2: Exercise Intervention
Intervention group (Arm 2): Children randomised to the intervention group will receive 24-months of current model of specialist CF care PLUS a weekly structured, individually prescribed and personally supervised exercise intervention at a local fitness facility or at school.
Other: Exercise Intervention
The exercise intervention will include aerobic, anaerobic, strength, core conditioning and stretching components.
- Forced expiratory volume in one second (FEV1) [ Time Frame: Baseline, 6, 12 and 24-month intervals. ]Spirometry data will also to be collected at outpatient clinics, annual reviews and during hospital admissions.
- Peak oxygen uptake (VO2Peak) [ Time Frame: Baseline, 12 and 24-month intervals ]Gold standard exercise test to determine peak oxygen uptake during exercise
- 10m-Modified Shuttle Walk Test [ Time Frame: Baseline, 6, 12 and 24 months ]Field test to assess functional exercise capacity. Distance covered and incremental level changes are evaluated over time.
- Lung Clearance Index [ Time Frame: Baseline, 12 and 24 months ]Multiple breath washout test to evaluate for changes in small airways
- Height, weight, body mass index measurements [ Time Frame: Baseline, 6, 12 and 24 months ]Height, weight and body mass index will be measured at regular intervals to evaluate for changes in growth parameters
- Cystic Fibrosis Questionnaire [ Time Frame: Baseline, 12 and 24 months ]Disease specific questionnaire to evaluate changes in quality of life in cystic fibrosis
- Cost of care [ Time Frame: Baseline, 12 and 24 months ]Evaluate differences in cost of care between the current model of CF care and the alternative model of care; and cost per patient.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889927
|Great Ormond Street Hospital for Children NHS Foundation Trust|
|London, United Kingdom, WC1N 3JH|
|Principal Investigator:||Sean J Ledger, BSc MSc||Cystic Fibrosis Unit, Great Ormond Street Hospital for Children NHS Foundation Trust|
|Principal Investigator:||Eleanor Main, BA MSc PhD||Institute of Child Health, University College London|