Cystic fibrosis Nutritional, Metabolic, Endocrine Cystic fibrosis
Conditions
Interventions
Staggered recruitment of the study population will occur over the first 6 months. Each child will participate in the study for at least 16-months following their recruitment. 160 children with cystic
Sponsors
UCL Great Ormond Street Institute of Child Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Documented diagnosis of cystic fibrosis 2. Using an ACT suitable for the Fizzyo sensor (Acapella, Astratech PEP, Aerobika or Pari PEP) at least once per day as part of their routine treatment 3. Aged 6-16 years 4. Currently under the care of a participating London CF Unit 5. Legally acceptable representative must be able to give informed consent
Exclusion criteria
Exclusion criteria: Patients who have had lung transplantation or have a clinically significant disease or medical condition other than CF or CF-related conditions that in the opinion of the MDT, would compromise the safety of the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence to home physiotherapy prescriptions for: 1. Airway clearance treatments (number of treatments, cycles, breaths per day). Adherence will be expressed as a proportion of personal prescription achieved and as a change from baseline measures in response to feedback or gaming. 2. Physical Activity (minutes per day of moderate to vigorous physical activity - calculated from heart rate and steps). This is usually defined as a percentage of the maximal heart rate achievable for a child of a particular age and gender (there are published normal tables for reference). Moderate physical activity might be considered as any activity at 55–70% of maximal heart rate, and vigorous physical activity, any activity at >70% of maximal heart rate. Cumulative minutes per day will automatically be calculated and expressed as a percentage of recommended levels. The above will be measured using data from remote monitoring sensors used throughout the study compared to clinical physiotherapy prescription and clinical records for 16 months throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Type of physiotherapy (type of airway clearance device, airway clearance and exercise prescription), collected by questionnaire at the baseline, midpoint and at the end of the study 2. The following airirway clearance session data, collected using bespoke Fizzyo sensor remote monitoring daily for 16 months: 2.1. Number of breaths per session 2.2. Frequency of session 2.3. Session breath profile 2.4. Session duration 3. Physical activity levels, assessed using Fitbit Alta HR remote monitoring, measurement of steps and heart rate, continuously for 16 months 4. Quality of Life, assessed using the Cystic Fibrosis Questionnaire Revised (CFQ-R)UK standardised questionnaire at the baseline, midpoint and at the end of the study 5. Lung function, assessed using spirometry testing at the baseline, midpoint and at the end of the study 6. Exercise capacity, assessed using the 10 m modified shuttle walk test at the baseline, midpoint and at the end of the study 7. The following clinical information collected throughout the study via clinical records: 7.1. Lung function results 7.2. Admissions 7.3. Medications 7.4. Infections 7.5. Comorbidities | — |
Countries
England, United Kingdom
Contacts
Public ContactEmma Raywood
Outcome results
None listed