NCT01889927: INSPIRE-CF

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

Completed NA Last updated 6 September 2019

What this trial tests

NA trial testing Exercise Intervention in Cystic Fibrosis in 71 participants. Completed in 31 December 2017.

Timeline

1 May 2012

Primary endpoint
31 December 2017

31 December 2017

Quick facts

Lead sponsor	Great Ormond Street Hospital for Children NHS Foundation Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	71
Start date	1 May 2012
Primary completion	31 December 2017
Estimated completion	31 December 2017
Sites	1 location across United Kingdom

Drugs / interventions tested

• Exercise Intervention

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Who can join

Adults 6 to 15, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.