Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001228774
Ethics application status
Approved
Date submitted
10/09/2013
Date registered
8/11/2013
Date last updated
8/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of a portable, non-invasive vibrator (the Respiratory Assist Device-RAD) to reduce breathlessness in people with Chronic Obstructive Pulmonary Disease (COPD).
Scientific title
In people with COPD does the RAD in the active position (placement) reduce breathlessness compared to a sham placement.
Secondary ID [1] 283161 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breathlessness 290016 0
Chronic obstructive pulmonary disease 290255 0
Condition category
Condition code
Respiratory 290399 290399 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description:
The RAD is a non-invasive, portable device consisting of two main components. The sensor and system controller form one component and the vibrators and vibrator controller form the other component. The respiration sensor is a 100K NTC thermister mounted on a plastic face mask such that the air flow through the face mask can effectively heat and cool the thermister in phase with respiration. The vibrators consist of an off-the-shelf vibrator (normally used in mobile phones) approximately 12mm in diameter and 3mm thick. When 3 volts DC is applied to the vibrator it vibrates at between 172Hz and 200Hz. The system is powered by two 1.5V “AA” alkaline batteries.

Application:
The vibrators are taped to the chest wall in either the active or sham position.

Procedure:
All participants will attend for two testing sessions during their regular visits to the pulmonary rehabilitation programme.
Session 1: Participants will cycle for 10 minutes commencing at an intensity of 60% of the peak work capacity calculated from their six-minute walk test (Hill et al 2008). Cycling work rate will be titrated up or down every minute to induce a breathlessness (dyspnoea) score of 3-4 (‘moderate’ to ‘somewhat severe’) on the 0-10 dyspnoea scale during the final 5 minutes of exercise. The work rate that elicits a breathless score of 3-4 during the final 5 minutes of exercise will be used for the two interventions in session 2.
Session 2: During Session 2 the participant will perform two 10 minute bouts of exercise on a stationary cycle at the work rate determined in Session 1 while wearing either the active or sham RAD in random order. Randomisation will be via random number generation (www.randomisation.com) and will be placed in opaque envelopes by a person independent of the study and opened on the day of Session 2 testing.
In Session 2 participants will rest for at least 1 hour between bouts of exercise, or until heart rate, oxygen saturation and breathlessness have returned to pre-exercise levels. During all exercise in Sessions 1 and 2, heart rate, oxygen saturation will be monitored using a pulse oximeter (Masimo Corp, Irvine, CA, USA) and breathlessness will be measured every minute using the modified Borg dyspnoea scale (Borg 1982). Exercise will be terminated if oxygen saturation drops below 85% or heart rate increases above predicted peak heart-rate.
Intervention code [1] 287891 0
Treatment: Devices
Comparator / control treatment
RAD in the sham placement.
Control group
Placebo

Outcomes
Primary outcome [1] 290424 0
A change in breathlessness >/= 1, as measured on the modified Borg scale.
Timepoint [1] 290424 0
During application of the RAD.
Secondary outcome [1] 304498 0
Oxygen saturation measured using pulse oximetry.
Timepoint [1] 304498 0
During application of the RAD.
Secondary outcome [2] 304991 0
Heart rate measured using pulse oximetry.
Timepoint [2] 304991 0
During application of RAD.

Eligibility
Key inclusion criteria
Diagnosis of COPD (FEV1/FVC <0.7).
Stable condition (no chest infections, hospital admissions or change in medications within the last month, no increase in shortness of breath).
Recently referred to pulmonary rehabilitation and having completed a six minute walk test.
Able to understand written and spoken English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with implanted electrophysiological devices.
Unable to exercise due to musculoskeletal, cardiovascular or neurological conditions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomsation table created by computor software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/09/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1490 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 7326 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 287915 0
Self funded/Unfunded
Name [1] 287915 0
Country [1] 287915 0
Primary sponsor type
Individual
Name
Dr Lyndal Maxwell
Address
Australian Catholic University
School of Physiotherapy
173 Pacific Hwy
North Sydney
NSW
2060
Country
Australia
Secondary sponsor category [1] 286643 0
None
Name [1] 286643 0
Address [1] 286643 0
Country [1] 286643 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289863 0
Royal Prince Alfred Hospital
Ethics committee address [1] 289863 0
Missendon Rd
Camperdown, NSW, 2050
Ethics committee country [1] 289863 0
Australia
Date submitted for ethics approval [1] 289863 0
Approval date [1] 289863 0
25/03/2013
Ethics approval number [1] 289863 0
HREC/08/RPAH/540

Summary
Brief summary
Breathlessness can stop people from being able to perform activities of daily living or exercise, and as such may have a negative impact on their quality of life. Past research has shown that applying mechanical vibration of 100 Hz to the chest wall decreases the sensation of breathlessness (dyspnoea) in both healthy subjects and in people with spinal cord injury, chronic obstructive airway disease and asthma. The devices used in previous research studies have not been portable nor have they been able to be used by people during activities of daily living. The Respiratory Aid Device (RAD) is a portable, battery operated, user friendly device which applies mechanical vibration (˜ 100 Hz) to the chest wall.

Participants with stable COPD will be recruited from the pulmonary rehabilitation programme at Royal Prince Alfred Hospital via a flyer. All participants will be seen twice during their regular visits to the pulmonary rehabilitation programme. On the first occasion the level of exercise that causes moderate breathlessness will be established. On the second occasion, participants will perform two (2) 10 minute exercise bouts on a stationary cycle at an intensity based on 60% of the calculated peak work capacity (Hill et al 2008). The RAD will be attached to the chest wall during both exercise bouts, with the order of the placement randomised to either the active position or sham position. . The severity of the sensation of breathlessness will be recorded at one minute intervals throughout the exercise sessions using the Borg breathlessness scale.

The RAD is a non-invasive, portable device consisting of two main components, a sensor and a vibrator. The respiration sensor is a 100K NTC thermister mounted on a plastic face mask such that the air flow through the face mask can effectively heat and cool the thermister in phase with respiration. The two vibrators consist of an off-the-shelf vibrator (normally used in mobile phones). When 3volts DC is applied to the vibrator it vibrates at 100Hz. The vibrators are taped to the chest wall. The system is powered by two 1.5V “AA” alkaline batteries.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42746 0
Dr Lyndal Maxwell
Address 42746 0
Australian Catholic University
School of Physiotherapy
PO Box 968 North Sydney NSW 2059
Country 42746 0
Australia
Phone 42746 0
61 2 97392254
Fax 42746 0
Email 42746 0
[email protected]
Contact person for public queries
Name 42747 0
Dr Lyndal Maxwell
Address 42747 0
Australian Catholic University
School of Physiotherapy
PO Box 968 North Sydney NSW 2059
Country 42747 0
Australia
Phone 42747 0
61 2 97392254
Fax 42747 0
Email 42747 0
[email protected]
Contact person for scientific queries
Name 42748 0
Dr Lyndal Maxwell
Address 42748 0
Australian Catholic University
School of Physiotherapy
PO Box 968 North Sydney NSW 2059
Country 42748 0
Australia
Phone 42748 0
61 2 97392254
Fax 42748 0
Email 42748 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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