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Short-term Effects of Physiotherapy on LCI

NCT ID: NCT03760120

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-21

Study Completion Date

2022-12-31

Brief Summary

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Although some studies have brought some evidences about the efficacy of positive expiratory pressure (PEP)-mask therapy as an airway clearance technique, yet it is not clearly understood what is the contribution of this technique in modifying peripheral ventilation inhomogeneity, a typical feature of patients with Cystic Fibrosis (CF).

The aim of this study is to investigate how PEP-MASK affects ventilation inhomogeneity in children and adolescents, with moderate to normal CF lung disease by the change in acinar airways (Sacin), lung clearance index (LCI) and conductive airways (Scond) indexes derived from nitrogen multiple-breath washout test (N2MBW).

Detailed Description

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Investigational device: PEP-MASK=Positive Expiratory Pressure delivered through a face mask.

Standard Operating Procedures used for evaluating CF lung disease and ventilation inhomogeneity.

Sample size: Based on preliminary data collected on seven subjects who performed nitrogen multiple-breath washout test before and after PEP-MASK, assuming a variation of 20% of Sacin, the study requires a sample size of 18 subjects.

Conditions

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Cystic Fibrosis

Keywords

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physiotherapy pulmonary function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Cross-over randomized controlled trial. Procedure: two nitrogen multiple-breath washout tests, one before and one after the intervention with PEP-Mask, either standard or sham allocation, during two subsequent mornings.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Technicians performing multiple-breath washout tests are blinded to treatment allocation; physiotherapists performing the treatment are blinded to multiple breath washout results; patients are blinded to the purpose of the study; the statistician will be blind to treatment allocation together with outcome assessors.

Study Groups

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PEP standard

Group Type ACTIVE_COMPARATOR

PEP-MASK

Intervention Type DEVICE

PEP sham

Group Type SHAM_COMPARATOR

PEP-MASK

Intervention Type DEVICE

Interventions

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PEP-MASK

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* CF diagnosis
* Patients hospitalized for a scheduled intravenous antibiotics cycle and regularly followed-up by the CF Centre
* ≥ 15 kilograms
* FEV1 ≥ 40%predicted
* Ability to perform NMBW test
* Ability to perform spirometry
* Willing to adhere to protocol procedures
* Patients in treatment with PEP-MASK

Exclusion Criteria

* Pulmonary Exacerbation within two last week
* Burkholderia cepacia infection
* Patients in lung transplantation waiting list
* Patients undergoing non invasive mechanical ventilation or oxygen therapy
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carla Colombo

Role: STUDY_DIRECTOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Locations

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Azienda Ospedaliero-Universitaria Meyer

Florence, , Italy

Site Status

Centro Regionale di Riferimento Fibrosi Cistica

Milan, , Italy

Site Status

Countries

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Italy

References

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Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

Reference Type BACKGROUND
PMID: 16055882 (View on PubMed)

Related Links

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http://www.mbwtraining.com/ECFS_MBW_SOP.pdf

Standard Operating Procedures LCI

Other Identifiers

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2291

Identifier Type: -

Identifier Source: org_study_id