Investigating outcome measures for trials of airway clearance techniques in adults with cystic fibrosis

Improving outcome measures for physiotherapy trials of airway clearance in adults with cystic fibrosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11220163

Enrollment

106

Registered

2016-09-19

Start date

2016-09-26

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic fibrosis Respiratory Cystic fibrosis

Interventions

Participants are randomised to one of two groups using a computerised randomisation programme, which means they attend two study visits in a random order. The visits take place up to 1 month apart. S

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of Cystic Fibrosis (confirmed by standard criteria) 2. Aged 16 years or over 3. Registered as patients of the Royal Brompton Hospital

Exclusion criteria

Exclusion criteria: 1. Evidence of pulmonary exacerbation within 3 weeks prior to screening 2. Any change in a chronic treatment/prophylaxis regimen for CF or CF-related condition within 4 weeks of visit Current infective exacerbation or reduction in lung function requiring therapeutic intervention 3. Current moderate haemoptysis (greater than streaking in the sputum) 4. Current dependency on positive pressure support with ACT Previous history of spontaneous rib fractures 5. Pregnancy Inability to give consent for treatment or measurement 6. Current dependency upon non-invasive ventilation Current dependency upon oxygen therapy

Design outcomes

Primary

Measure	Time frame
1. Forced expiratory volume in 1 second (FEV1) is measured using spirometry immediately before and after the trial condition on each study visit 2. Lung clearance index (LCI) is measured using a multiple breath washout test immediately before and after the trial condition on each study visit 3. Impulse Oscillometry (IOS) is measured by a relaxed breathing test immediately before and after the trial condition on each study visit 4. Sputum weight is measured by weighing the amount of sputum expectorated during the treatment session immediately after the trial condition on each study visit 5. Electronic impedance tomography is measured during the treatment via an electrode belt around the chest, with measurements before, after and during the trial condition on each study visit	—

Measure

Time frame

1. Forced expiratory volume in 1 second (FEV1) is measured using spirometry immediately before and after the trial condition on each study visit 2. Lung clearance index (LCI) is measured using a multiple breath washout test immediately before and after the trial condition on each study visit 3. Impulse Oscillometry (IOS) is measured by a relaxed breathing test immediately before and after the trial condition on each study visit 4. Sputum weight is measured by weighing the amount of sputum expectorated during the treatment session immediately after the trial condition on each study visit 5. Electronic impedance tomography is measured during the treatment via an electrode belt around the chest, with measurements before, after and during the trial condition on each study visit

—

Secondary

Measure	Time frame
1. Patient opinion of the outcome measure tests are measured using a questionnaire designed for the purpose of this study at the end of each study visit 2. Lung function tests (FVC, FEF 25, FEF 50, FEF 75) are completed using a spirometer before and after the trial condition in each study visit 3. Oxygen saturation is measured via a finger probe during the trial condition on each study visit	—

Countries

England, United Kingdom

Contacts

Public ContactGemma Stanford

g.stanford@rbht.nhs.uk+44 20 7352 8121 ext 4028

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026