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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Other | The exercise intervention will include aerobic, anaerobic, strength, core conditioning and stretching components. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak oxygen uptake (VO2Peak) | Gold standard exercise test to determine peak oxygen uptake during exercise | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Ormond Street Hospital for Children NHS Foundation Trust | London | WC1N 3JH | United Kingdom |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 13, 2023 | |
| Reset | Nov 22, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 13, 2023 | Nov 22, 2023 |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Baseline, 6, 12 and 24 months |
| Lung Clearance Index | Multiple breath washout test to evaluate for changes in small airways | 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 | Baseline, 6, 12 and 24 months |
| Cystic Fibrosis Questionnaire | Disease specific questionnaire to evaluate changes in quality of life in cystic fibrosis | 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. | Baseline, 12 and 24 months |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001519 | Behavior |