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

NCT01889927 | Completed DMC

• 1 other identifier: 11AR13
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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. 1.Determine differences, if any, in lung function between the two groups;
2. 2.Determine differences, if any, in exercise capacity between the two groups;
3. 3.Evaluate cost of care of alternate model of care versus current model of care.

Conditions

Cystic Fibrosis

Keywords

exercise; physiotherapy; lung function; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Peak oxygen uptake (VO2Peak)

  Baseline, 12 and 24-month intervals

• 10m-Modified Shuttle Walk Test

  Baseline, 6, 12 and 24 months

• Lung Clearance Index

  Baseline, 12 and 24 months

• Height, weight, body mass index measurements

  Baseline, 6, 12 and 24 months

• Cystic Fibrosis Questionnaire

  Baseline, 12 and 24 months

Study Arms (2)

Group 1: Control

NO INTERVENTION

Control Group (Arm 1): Children randomised to the control group will receive 24-months of current model of specialist CF care.

Group 2: Exercise Intervention

ACTIVE COMPARATOR

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

Interventions

Exercise Intervention OTHER

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

Group 2: Exercise Intervention

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

Study Sites (1)

Great Ormond Street Hospital for Children NHS Foundation Trust

London, WC1N 3JH, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: July 1, 2013
• Study Start: May 1, 2012
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

GB (1)