Back to resultsINSPIRE-CF: an Alternative Physiotherapy Model for Children With Cystic Fibrosis (INSPIRE-CF)
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring exercise, physiotherapy, lung function, quality of life
Eligibility Criteria
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.
Sites / Locations
- Great Ormond Street Hospital for Children NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Group 1: Control
Group 2: Exercise Intervention
Arm Description
Control Group (Arm 1): Children randomised to the control group will receive 24-months of current model of specialist CF care.
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.
Outcomes
Primary Outcome Measures
Forced expiratory volume in one second (FEV1)
Spirometry data will also to be collected at outpatient clinics, annual reviews and during hospital admissions.
Secondary Outcome Measures
Peak oxygen uptake (VO2Peak)
Gold standard exercise test to determine peak oxygen uptake during exercise
10m-Modified Shuttle Walk Test
Field test to assess functional exercise capacity. Distance covered and incremental level changes are evaluated over time.
Lung Clearance Index
Multiple breath washout test to evaluate for changes in small airways
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
Cystic Fibrosis Questionnaire
Disease specific questionnaire to evaluate changes in quality of life in cystic fibrosis
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.
Full Information
NCT ID
NCT01889927
First Posted
June 11, 2013
Last Updated
September 4, 2019
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01889927
Brief Title
INSPIRE-CF: an Alternative Physiotherapy Model for Children With Cystic Fibrosis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2012 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
exercise, physiotherapy, lung function, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Control
Arm Type
No Intervention
Arm Description
Control Group (Arm 1): Children randomised to the control group will receive 24-months of current model of specialist CF care.
Arm Title
Group 2: Exercise Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
The exercise intervention will include aerobic, anaerobic, strength, core conditioning and stretching components.
Primary Outcome Measure Information:
Title
Forced expiratory volume in one second (FEV1)
Description
Spirometry data will also to be collected at outpatient clinics, annual reviews and during hospital admissions.
Time Frame
Baseline, 6, 12 and 24-month intervals.
Secondary Outcome Measure Information:
Title
Peak oxygen uptake (VO2Peak)
Description
Gold standard exercise test to determine peak oxygen uptake during exercise
Time Frame
Baseline, 12 and 24-month intervals
Title
10m-Modified Shuttle Walk Test
Description
Field test to assess functional exercise capacity. Distance covered and incremental level changes are evaluated over time.
Time Frame
Baseline, 6, 12 and 24 months
Title
Lung Clearance Index
Description
Multiple breath washout test to evaluate for changes in small airways
Time Frame
Baseline, 12 and 24 months
Title
Height, weight, body mass index measurements
Description
Height, weight and body mass index will be measured at regular intervals to evaluate for changes in growth parameters
Time Frame
Baseline, 6, 12 and 24 months
Title
Cystic Fibrosis Questionnaire
Description
Disease specific questionnaire to evaluate changes in quality of life in cystic fibrosis
Time Frame
Baseline, 12 and 24 months
Title
Cost of care
Description
Evaluate differences in cost of care between the current model of CF care and the alternative model of care; and cost per patient.
Time Frame
Baseline, 12 and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean J Ledger, BSc MSc
Organizational Affiliation
Cystic Fibrosis Unit, Great Ormond Street Hospital for Children NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eleanor Main, BA MSc PhD
Organizational Affiliation
Institute of Child Health, University College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Great Ormond Street Hospital for Children NHS Foundation Trust
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
INSPIRE-CF: an Alternative Physiotherapy Model for Children With Cystic Fibrosis
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