PEP Flute-selfcare in COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID-19
- Sars Cov 2
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study is designed as a randomised, controlled, open-label trial with two parallel groups and a primary endpoint of CAT-score after 30 days of intervention. Randomization lists will be computer-generated using an appropriate statistical software and based upon permuted random blocks. The allocation ratio will be 1:1 stratified for the following baseline conditions: Sex Age (?60 and <60 years) Masking: Single (Outcomes Assessor)Masking Description: Outcome assessors will be blinded to treatment allocation where possible. This is of outmost importance, and participants are requested not to disclose their allocation when outcomes are assessed. To test the blinding efficacy, the outcome assessors are asked what treatment strategy they think a patient has received after assessments.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
It is hypothesized that the PEP flute has positive effects on SARS-CoV-2 infected individual's self-reported respiratory symptoms such as dyspnoea, coughing and perceived mucus clearance through beneficial effects on lung function and airway clearance. Furthermore, the investigators expect a lower r...
It is hypothesized that the PEP flute has positive effects on SARS-CoV-2 infected individual's self-reported respiratory symptoms such as dyspnoea, coughing and perceived mucus clearance through beneficial effects on lung function and airway clearance. Furthermore, the investigators expect a lower rate of hospitalization and use of antibiotics in the intervention group as compared to the control group. Finally, potential subgroup effects by gender, age, comorbidity and BMI at study entry will be explored for all outcomes. Based upon a sample size estimation the investigators assess that inclusion of 200 participants in each intervention arm will be an adequate number. Based on the present testing strategy and COVID-19 incidence, current expectations are that two months should be enough to recruit 400 patients. The investigators will allow for recruitment to the end of December 2020, but will terminate enrolment at n = 400. Link to detailed protocol paper will be added once published.
Tracking Information
- NCT #
- NCT04530435
- Collaborators
- Hvidovre University Hospital
- Investigators
- Principal Investigator: Berit L. Heitmann, Professor, Ph.D Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospitals, Denmark
Get Well Soon