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Randomized Controlled Trial
. 2022 Oct 18;17(10):e0276310.
doi: 10.1371/journal.pone.0276310. eCollection 2022.

Airway clearance physiotherapy and health-related quality of life in cystic fibrosis

Affiliations
Randomized Controlled Trial

Airway clearance physiotherapy and health-related quality of life in cystic fibrosis

Sandra Gursli et al. PLoS One. .

Abstract

Objective: Airway clearance physiotherapy is recommended in cystic fibrosis, but limited evidence exists to suggest how much treatment is enough. As a secondary analysis of a prior study investigating the safety, efficacy, and participants' perceptions of a novel airway clearance technique, specific cough technique (SCT) compared to forced expiration technique (FET), we aimed to evaluate whether the intervention was associated with changes in health-related quality of life (HRQoL).

Methods: We conducted randomised, controlled individual trials with six adults (N-of-1 RCTs). Each trial included eight weeks of treatment, twice a week, using saline inhalation in horizontal positions, one with SCT and one with FET, in random order. Efficacy was measured by sputum wet weight (g) after each session. Perceived usefulness and preference were self-reported at the end of the study. Lung function was assessed at baseline and at the end of study. HRQoL was measured using the Cystic Fibrosis Questionnaire-Revised (CFQ-R) at baseline (week 1) and at completion of the study (week 8). Individual HRQoL scores (0-100) were coded and analysed using CFQ-R Software Program, version 2.0.

Results: Patient-reported outcomes were completed by all subjects. Individual CFQ-R-Respiratory Symptoms Scores (CFQ-R-RSS) showed a positive change, meeting the minimal important difference (MID) ≥ 4 points in five participants and a negative change in one individual. A strong correlation (r = 0.94 (p<0.01) was found between total sputum weight (g) and the positive changes in CFQ-R-RSS, and between changes in lung function and CFQ-R-RSS (r = 0.84 (p = 0.04).

Conclusion: The airway clearance intervention was associated with clinically meaningful changes in patient-reported symptoms on the CFQ-R in the majority of the participants. This finding warrants further investigation regarding treatment, duration and frequency. A long-term study may reveal beneficial effects on other clinically meaningful endpoints, such as pulmonary exacerbations, high-resolution computed tomography scores and HRQoL.

Trial registration: The study was registered in ClinicalTrials.gov, under the number NCT0 1266473.

Trial registration: ClinicalTrials.gov NCT01266473.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Treatment method.
Fig 2
Fig 2. The correlation between total sputum weight (g) produced by the participants during the study (week 1–8) and the change in CFQ-R-RSS.
Fig 3
Fig 3. The correlation between change in FEV1 (start and end of study) and the change in CFQ-R-RSS (start and end of study).
Fig 4
Fig 4. The correlation between change in FEF50 (start and end of study) and the change in CFQ-R-RSS (start and end of study).
Fig 5
Fig 5. Need for airway clearance, study intervention and the relationships with HRQoL and lung function.

References

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