Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-01-10

Brief Summary

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This is a pilot study investigating the effectiveness and clinical efficacy of airway clearance therapy (ACT) in cystic fibrosis (CF). Enrolled subjects will undergo measurements of mucociliary clearance (MCC) and exhaled biomarkers at baseline and after 3 different forms of ACT: high frequency chest wall oscillatory vest, oscillatory positive expiratory pressure device, and whole-body vibration.

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Detailed Description

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Conditions

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Cystic Fibrosis Mucociliary Clearance Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All subjects will undergo baseline testing, followed by study procedures for three separate interventions, with subjects randomized into three arms in which a different sequence in which to complete the studies.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sequence A

In this arm, the interventions were performed in the following order:

Baseline (prior to randomization), Whole body vibration, High Frequency Chest Wall Oscillation (HFCWO, aka "Vest" or TheVest®), Oscillatory Positive Expiratory Pressure (OPEP) (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)

Group Type ACTIVE_COMPARATOR

Baseline (Huff-Cough alone)

Intervention Type OTHER

Subjects will provide two "huffs" (forced expiratory maneuver with open glottis) followed by a cough every six minutes for a total of six Huff-Coughs.

Oscillatory Positive Expiatory Pressure Device

Intervention Type DEVICE

Subjects will use an Areobika® branded OPEP device (10 breaths through highest tolerated resistance) prior to undergoing a Huff-Cough. Subjects will use the device six times every six minutes.

Whole-Body Vibration Platform

Intervention Type DEVICE

Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart.

High Frequency Chest Wall Oscillatory Vest

Intervention Type DEVICE

Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough.

Sequence B

In this arm, the interventions were performed in the following order:

Baseline (prior to randomization), HFCWO, OPEP, Whole body vibration (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)

Group Type ACTIVE_COMPARATOR

Baseline (Huff-Cough alone)

Intervention Type OTHER

Subjects will provide two "huffs" (forced expiratory maneuver with open glottis) followed by a cough every six minutes for a total of six Huff-Coughs.

Oscillatory Positive Expiatory Pressure Device

Intervention Type DEVICE

Subjects will use an Areobika® branded OPEP device (10 breaths through highest tolerated resistance) prior to undergoing a Huff-Cough. Subjects will use the device six times every six minutes.

Whole-Body Vibration Platform

Intervention Type DEVICE

Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart.

High Frequency Chest Wall Oscillatory Vest

Intervention Type DEVICE

Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough.

Sequence C

In this arm, the interventions were performed in the following order:

Baseline (prior to randomization), OPEP, Whole body vibration, HFCWO (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)

Group Type ACTIVE_COMPARATOR

Baseline (Huff-Cough alone)

Intervention Type OTHER

Subjects will provide two "huffs" (forced expiratory maneuver with open glottis) followed by a cough every six minutes for a total of six Huff-Coughs.

Oscillatory Positive Expiatory Pressure Device

Intervention Type DEVICE

Subjects will use an Areobika® branded OPEP device (10 breaths through highest tolerated resistance) prior to undergoing a Huff-Cough. Subjects will use the device six times every six minutes.

Whole-Body Vibration Platform

Intervention Type DEVICE

Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart.

High Frequency Chest Wall Oscillatory Vest

Intervention Type DEVICE

Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough.

Interventions

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Baseline (Huff-Cough alone)

Subjects will provide two "huffs" (forced expiratory maneuver with open glottis) followed by a cough every six minutes for a total of six Huff-Coughs.

Intervention Type OTHER

Oscillatory Positive Expiatory Pressure Device

Subjects will use an Areobika® branded OPEP device (10 breaths through highest tolerated resistance) prior to undergoing a Huff-Cough. Subjects will use the device six times every six minutes.

Intervention Type DEVICE

Whole-Body Vibration Platform

Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart.

Intervention Type DEVICE

High Frequency Chest Wall Oscillatory Vest

Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough.

Intervention Type DEVICE

Other Intervention Names

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Aerobika PowerPlate TheVest

Eligibility Criteria

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Inclusion Criteria

* Adults with confirmed diagnosis of cystic fibrosis aged 18 years and older.

Exclusion Criteria

* Pregnant or lactating women,
* Individuals with severe lung disease (FEV1 \<30%), or with exacerbations of lung disease requiring antibiotics or medication change within four weeks prior to enrolment.
* Individuals unable to use vest-based HFCWO, OPEP device, or who require oxygen supplementation at rest.
* Individuals with significant balance or gait impairment preventing them from tolerating being positioned on a vibrating platform.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No