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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: Exercise Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2012
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Peak oxygen uptake (VO2Peak) [ Time Frame: Baseline, 12 and 24-month intervals ]
    Gold standard exercise test to determine peak oxygen uptake during exercise

  2. 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.

  3. Lung Clearance Index [ Time Frame: Baseline, 12 and 24 months ]
    Multiple breath washout test to evaluate for changes in small airways

  4. 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

  5. Cystic Fibrosis Questionnaire [ Time Frame: Baseline, 12 and 24 months ]
    Disease specific questionnaire to evaluate changes in quality of life in cystic fibrosis

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889927


Locations
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United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
London, United Kingdom, WC1N 3JH
Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
Investigators
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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
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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01889927    
Other Study ID Numbers: 11AR13
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Keywords provided by Great Ormond Street Hospital for Children NHS Foundation Trust:
exercise
physiotherapy
lung function
quality of life
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases