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

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ClinicalTrials.gov Identifier: NCT01889927
Recruitment Status : Completed
First Posted : July 1, 2013
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE June 11, 2013
First Posted Date  ICMJE July 1, 2013
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE May 1, 2012
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2015)
Forced expiratory volume in one second (FEV1) [ Time Frame: Baseline, 6, 12 and 24-month intervals. ]
Spirometry data will also to be collected at outpatient clinics, annual reviews and during hospital admissions.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
Forced expiratory volume in one second (FEV1) [ Time Frame: Baseline, 6, 12, 18 and 24-month intervals. ]
Spirometry data will also to be collected at outpatient clinics, annual reviews and during hospital admissions.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2015)
  • Peak oxygen uptake (VO2Peak) [ Time Frame: Baseline, 12 and 24-month intervals ]
    Gold standard exercise test to determine peak oxygen uptake during exercise
  • 10m-Modified Shuttle Walk Test [ Time Frame: Baseline, 6, 12 and 24 months ]
    Field test to assess functional exercise capacity. Distance covered and incremental level changes are evaluated over time.
  • Lung Clearance Index [ Time Frame: Baseline, 12 and 24 months ]
    Multiple breath washout test to evaluate for changes in small airways
  • Height, weight, body mass index measurements [ Time Frame: Baseline, 6, 12 and 24 months ]
    Height, weight and body mass index will be measured at regular intervals to evaluate for changes in growth parameters
  • Cystic Fibrosis Questionnaire [ Time Frame: Baseline, 12 and 24 months ]
    Disease specific questionnaire to evaluate changes in quality of life in cystic fibrosis
  • Cost of care [ Time Frame: Baseline, 12 and 24 months ]
    Evaluate differences in cost of care between the current model of CF care and the alternative model of care; and cost per patient.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
  • Peak oxygen uptake (VO2Peak) [ Time Frame: Baseline, 12 and 24-month intervals ]
    Gold standard exercise test to determine peak oxygen uptake during exercise
  • 10m-Modified Shuttle Walk Test [ Time Frame: Baseline, 6, 12, 18 and 24 months ]
    Field test to assess functional exercise capacity. Distance covered and incremental level changes are evaluated over time.
  • Lung Clearance Index [ Time Frame: Baseline, 12 and 24 months ]
    Multiple breath washout test to evaluate for changes in small airways
  • Height, weight, body mass index measurements [ Time Frame: Baseline, 6, 12, 18 and 24 months ]
    Height, weight and body mass index will be measured at regular intervals to evaluate for changes in growth parameters
  • Cystic Fibrosis Questionnaire [ Time Frame: Baseline, 12 and 24 months ]
    Disease specific questionnaire to evaluate changes in quality of life in cystic fibrosis
  • Cost of care [ Time Frame: Baseline, 12 and 24 months ]
    Evaluate differences in cost of care between the current model of CF care and the alternative model of care; and cost per patient.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE INSPIRE-CF: an Alternative Physiotherapy Model for Children With Cystic Fibrosis
Official Title  ICMJE INSPIRE-CF: A Randomised Controlled Trial Investigating the Clinical and Economic Benefits of an Alternative Model of Physiotherapy Care for Children With Cystic Fibrosis
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:

  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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE Other: Exercise Intervention
The exercise intervention will include aerobic, anaerobic, strength, core conditioning and stretching components.
Study Arms  ICMJE
  • No Intervention: Group 1: Control
    Control Group (Arm 1): Children randomised to the control group will receive 24-months of current model of specialist CF care.
  • Active Comparator: Group 2: Exercise Intervention
    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: Other: Exercise Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2015)
71
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2013)
66
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01889927
Other Study ID Numbers  ICMJE 11AR13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Great Ormond Street Hospital for Children NHS Foundation Trust
Study Sponsor  ICMJE Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sean J Ledger, BSc MSc Cystic Fibrosis Unit, Great Ormond Street Hospital for Children NHS Foundation Trust
Principal Investigator: Eleanor Main, BA MSc PhD Institute of Child Health, University College London
PRS Account Great Ormond Street Hospital for Children NHS Foundation Trust
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP