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

Cystic Fibrosis Clinical Trial

— INSPIRE-CF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889927
• Other study ID #: 11AR13
• Status: Completed
• Phase: N/A
• Start date: May 1, 2012
• Est. completion date: December 31, 2017

Study information

• Verified date: September 2019
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Exercise Intervention
The exercise intervention will include aerobic, anaerobic, strength, core conditioning and stretching components.

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital for Children NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in one second (FEV1)	Spirometry data will also to be collected at outpatient clinics, annual reviews and during hospital admissions.	Baseline, 6, 12 and 24-month intervals.
Secondary	Peak oxygen uptake (VO2Peak)	Gold standard exercise test to determine peak oxygen uptake during exercise	Baseline, 12 and 24-month intervals
Secondary	10m-Modified Shuttle Walk Test	Field test to assess functional exercise capacity. Distance covered and incremental level changes are evaluated over time.	Baseline, 6, 12 and 24 months
Secondary	Lung Clearance Index	Multiple breath washout test to evaluate for changes in small airways	Baseline, 12 and 24 months
Secondary	Height, weight, body mass index measurements	Height, weight and body mass index will be measured at regular intervals to evaluate for changes in growth parameters	Baseline, 6, 12 and 24 months
Secondary	Cystic Fibrosis Questionnaire	Disease specific questionnaire to evaluate changes in quality of life in cystic fibrosis	Baseline, 12 and 24 months
Secondary	Cost of care	Evaluate differences in cost of care between the current model of CF care and the alternative model of care; and cost per patient.	Baseline, 12 and 24 months