Improving adherence with PEP (Positive end expiratory) chest physiotherapy in children with cystic fibrosis though the use of an electronic device, the PEP PT (Personal trainer)

• Register: ANZCTR
• Last refreshed on: 5 July 2021
• Main ID: ACTRN12613000929707
• Date of registration: 22/08/2013
• Prospective Registration: Yes
• Primary sponsor: Mater Health Service
• Public title: Improving adherence with PEP (Positive end expiratory) chest physiotherapy in children with cystic fibrosis though the use of an electronic device, the PEP PT (Personal trainer)
• Scientific title: Does the use of the PEP PT (a computer enhanced positive end expiratory chest physiotherapy device) in children with cystic fibrosis improve adherence with chest physiotherapy compared with standard PEP chest physiotherapy
• Date of first enrolment: 01/10/2013
• Target sample size: 36
• Recruitment status: Withdrawn
• URL: https://anzctr.org.au/ACTRN12613000929707.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Other;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Scott Burgesss

• Name: Dr Scott Burgess

Key inclusion & exclusion criteria

Inclusion criteria: Cystic Fibrosis, using PEP and currently well.
Exclusion criteria: FEV1 less than 40% predicted

Age minimum: 4 Years
Age maximum: 16 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Human Genetics and Inherited Disorders - Cystic fibrosis

Respiratory - Other respiratory disorders / diseases

Cystic Fibrosis;
Cystic Fibrosis

Intervention(s)

The PEP Personal Trainer is a newly developed device which has been designed to provide both PEP (positive end expiratory pressure) chest physiotherapy and some key additional functions. A PEP mask is held to the face by the user. The user inhales gently through the mask and then exhales against resistance because of a one way valve and resistor. This provides pressure back down their airway. It is suggested that the subject reach and maintain 10-20cm water pressure for 3 seconds. This is a standard and well proven form of chest physiotherapy. During a session a user will normal perform 100 exhalations. The PEP PT measures the pressure associated with each blow using a electronic sensor contained within the mask. The PEP PT connects wirelessly to a tablet device. The key features of the device include: 1. An alarm to remind the subject to perform their PEP (typically done twice daily), 2. The screen displays the ideal pressure curve which the subject can follow to ensure an ideal technique, 3. The subject can play games on the device which again require and encourage an ideal technique (for example piloting a space ships which collects asteroids), 4. The device counts the number of blows performed and provides prompts and encouragement, 5. The devices scores each blow and assigns a point for each effective blow (PEP points) which the child's parent can redeem for rewards, 6. The device stores information about both adherence and technique which can be reviewed at consultations. In this trial subjects will be randomised to either the PEP PT or a control device which measures adherence and technique but does not connect to a screen or have the other features. The subjects use either device for 6 weeks. Subjects assigned to the control device then use the PEP PT for six w

Primary Outcome(s)

Adherence with chest physiotherapy as measured by the PEP device (for example if the patient is prescribed 100 blows in the morning and one hundred at night and they perform 100 blows in the morning and 50 at night, they will be assigned 100% adherence for the morning and 50% for the night).[6 weeks]

Secondary Outcome(s)

Technique with PEP. Each blow will be assessed against set criteria. The device will count the number of "good" blows. The number of "good" blows with the PEP PT compared to the control device with be the secondary outcome.[6 weeks]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Golden Casket Grant, Mater Children's Hospital

Ethics review

Status: Approved
Approval date: 01/07/2013
Contact:

Mater Health Services HREC