MedTrace Logo

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

NCT01889927 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2019-09-06

No results posted yet for this study

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

Interventions

OTHER

Exercise Intervention

The exercise intervention will include aerobic, anaerobic, strength, core conditioning and stretching components.

Sponsors & Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Sean J Ledger, BSc MSc · Cystic Fibrosis Unit, Great Ormond Street Hospital for Children NHS Foundation Trust

  • Eleanor Main, BA MSc PhD · Institute of Child Health, University College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-01
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01889927 on ClinicalTrials.gov