NCT01889927

INSPIRE-CF: an Alternative Physiotherapy Model for Children With Cystic Fibrosis

INSPIRE-CF: A Randomised Controlled Trial Investigating the Clinical and Economic Benefits of an Alternative Model of Physiotherapy Care for Children With Cystic Fibrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

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 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: 1. Determine differences, if any, in lung function between the two groups; 2. Determine differences, if any, in exercise capacity between the two groups; 3. Evaluate cost of care of alternate model of care versus current model of care.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
OTHER	Exercise Intervention	The exercise intervention will include aerobic, anaerobic, strength, core conditioning and stretching components.

Timeline

• Start date: 2012-05-01
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2013-07-01
• Last updated: 2019-09-06

Locations

1 site across 1 country: United Kingdom