Cystic FibrosisINSPIRE-CFNCT01889927
INSPIRE-CF: an Alternative Physiotherapy Model for Children With Cystic Fibrosis
A study testing Exercise Intervention in people with Cystic Fibrosis, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2012to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 3JH
About this study
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
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).
Read more
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.
- Conditions
- Cystic Fibrosis
- Being tested
- Exercise Intervention
- Keywords
- exercise, physiotherapy, lung function, quality of life
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The exercise intervention will include aerobic, anaerobic, strength, core conditioning and stretching components.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in one second (FEV1)
Spirometry data will also to be collected at outpatient clinics, annual reviews and during hospital admissions.
Measured: Baseline, 6, 12 and 24-month intervals.
Secondary outcomes (6)
Peak oxygen uptake (VO2Peak)
Gold standard exercise test to determine peak oxygen uptake during exercise
Measured: Baseline, 12 and 24-month intervals
10m-Modified Shuttle Walk Test
Field test to assess functional exercise capacity. Distance covered and incremental level changes are evaluated over time.
Measured: Baseline, 6, 12 and 24 months
Lung Clearance Index
Multiple breath washout test to evaluate for changes in small airways
Measured: Baseline, 12 and 24 months
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
Measured: Baseline, 6, 12 and 24 months
Cystic Fibrosis Questionnaire
Disease specific questionnaire to evaluate changes in quality of life in cystic fibrosis
Measured: Baseline, 12 and 24 months
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.
Measured: Baseline, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study start1 May 2012
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean J Ledger, BSc MSc, Principal investigator, Cystic Fibrosis Unit, Great Ormond Street Hospital for Children NHS Foundation TrustEleanor Main, BA MSc PhD, Principal investigator, Institute of Child Health, University College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889927
- Sponsor's protocol ID
- 11AR13
- Acronym
- INSPIRE-CF
- Status last verified
- Sep 2019
- First submitted
- 11 Jun 2013
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01889927
- Acronym / sponsor ID
- INSPIRE-CF / 11AR13
- Conditions
- Cystic Fibrosis
- Keywords
- exercise, physiotherapy, lung function, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 May 2012 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 1 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Exercise InterventionIntervention 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. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionThe exercise intervention will include aerobic, anaerobic, strength, core conditioning and stretching components. | Other | Group 2: Exercise Intervention |
Primary outcome
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.
6 secondary outcomes
Peak oxygen uptake (VO2Peak)
Time frame: Baseline, 12 and 24-month intervals
10m-Modified Shuttle Walk Test
Time frame: Baseline, 6, 12 and 24 months
Lung Clearance Index
Time frame: Baseline, 12 and 24 months
Height, weight, body mass index measurements
Time frame: Baseline, 6, 12 and 24 months
Cystic Fibrosis Questionnaire
Time frame: Baseline, 12 and 24 months
Cost of care
Time frame: Baseline, 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean J Ledger, BSc MSc principal investigator
Cystic Fibrosis Unit, Great Ormond Street Hospital for Children NHS Foundation Trust
Eleanor Main, BA MSc PhD principal investigator
Institute of Child Health, University College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Cystic Fibrosis, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume in one second (FEV1) (time frame: Baseline, 6, 12 and 24-month intervals.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.