| Methods |
Phase I: cross‐over RCT. Phase II: parallel RCT. |
| Participants |
Phase I 10 participants with mild to moderate disease Mean (SD) age: 30 (7) years. Mean (SD) height: 168 (10) cm. Mean (SD) weight: 67 (14) kg. Mean (SD) BMI: 24 (4) kg/m2. Mean (SD) BSA: 1.7 (0.2) m2. Mean (SD) FEV₁ % predicted: 70 (24) %. Mean (SD) FVC % predicted: 85 (20) %. Phase II 12 hospitalised participants (VibraLung® group n = 3; Vest® group n = 9). Mean (SD) age: 23 (6) years. Mean (SD) height: 165 (6) cm. Mean (SD) weight: 60 (10) kg. Mean (SD) BMI: 22 (3) kg/m2. Mean (SD) BSA: 1.7 (0.2) m2. Mean (SD) FEV₁ % predicted: 60 (20) %. Mean (SD) FVC % predicted: 76 (18) %. |
| Interventions |
Phase I: single intervention where VibraLung® used with sound or without sound for 20 minutes; on 2nd visit crossed over to alternative treatment. Phase II: 5 days of in‐hospital therapy for 2 sessions/day with either VibraLung® or the Vest®. |
| Outcomes |
Phase I: pulmonary function; lung diffusion for carbon monoxide and nitric oxide; lung clearance index; symptoms; oxygen saturation. Measurements at baseline, 1‐hour and 4‐hours post‐treatment. Phase II: sputum collected for 20 minutes post‐treatment. |
| Notes | Only Phase II likely eligible for inclusion; await full publication of results. |
BMI: body mass index BSA: body surface area CFQ‐R: cystic fibrosis questionnaire ‐ revised FEV₁: forced expiratory volume at one second FVC: forced vital capacity HAT: hydro acoustic therapy HFCWO: high frequency chest wall oscillation PEP: positive expiratory pressure RCT: randomised controlled trial SD: standard deviation