Investigation of a portable, non-invasive vibrator (the Respiratory Assist Device-RAD) to reduce breathlessness in people with Chronic Obstructive Pulmonary Disease (COPD).
In people with COPD does the RAD in the active position (placement) reduce breathlessness compared to a sham placement.
Dr Lyndal Maxwell
35 participants
Sep 11, 2013
Interventional
Conditions
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.
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Interventions
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.
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ACTRN12613001228774