Aim of the study

To assess safety and feasibility of Simeox physiotherapy during the pulmonary exacerbation treatment in adult Cystic Fibrosis

patients in clinical setting compared to conventional physiotherapy.

Materials and Methods

Patients. Adult Cystic Fibrosis patients, having an in-patient pulmonary exacerbation treatment were included in prospective,

monocentric, randomized controlled study.

The Study group was formed of 5 patients randomized to have Simeox (physio-Assist, France) physiotherapy together with

standard medical treatment of CF pulmonary exacerbation in pulmonology department. 5 patients were randomized for the

Control group and were treated with standard CF pulmonary exacerbation medical treatment together with traditional manual

physiotherapy technique.

The groups were comparable by main anthropometric, microbiological and functional characteristics (Table 1). In all cases

Cystic Fibrosis was diagnosed in early childhood and was confirmed by clinical findings, positive sweat test and CFTR

genotyping. The patients had chronic respiratory infection with non-fermenting gram-negative bacteria and were pancreatic

insufficient mostly. No one of the patients included had recent hemoptysis, pneumothorax 6 months or less prior to the study,

all of them could perform spirometry, had no contra-indication to manual or instrumental physiotherapy and did not

participate in another clinical trial.

The clinical and functional assessment of the patients was performed before the start and after 5 days of treatment.

The questionnaire (provided by PhysioAssist company), reporting the ability of the patient to use the device, adverse events,

reported outcomes, as well as the chest expansion and SpO2 measurement, spirometry and expectorated sputum

volume were evaluated.

Table 1 | The Study and Control group characteristics

IQR: Interquartile range; Med: median

Study group, n=5 Control group, n=5 P

25.0 (5.0) 24.0 (7.0) 0.753Age, Med (IQR), years

1/4 2/3 0.783Gender, M/F

5 5 1.0P.aeruginosa, n

18.0 (6.3) 20 (5.7) 0.602BMI, Med (IQR), kg/m2

45.0 (21.5) 50 (9.0) 0.527FEV1, Меd (IQR), % pred

Pain during treatment 2.7 by 10-score scale (0 no pain > 10 painful)

Was it easy to relax during passive exhalation? 2.5 by 4-score scale (1 easy > 4 difficult)

Questionnaire evaluation:

Simeox physiotherapy was evaluated by 5 patients as follows:

Fatigue 3.5 by 10-score scale (0 low > 10 high)

Is it easier to breathe? 2.5 by 4-score scale (1 easy > 4 difficult)

Expectorated sputum characteristics? 1.5 by 4-score scale (1 copious sputum > 4 scanty and foamy sputum)

10