Short-term Effects of Physiotherapy on LCI
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 18
Summary
- Conditions
- Cystic Fibrosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: 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.Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: 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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 5 years and 18 years
- Gender
- Both males and females
Description
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 wash...
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.
Tracking Information
- NCT #
- NCT03760120
- Collaborators
- Not Provided
- Investigators
- Study Director: Carla Colombo Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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