Measuring physical activity using electronic measurement devices
Research type
Research Study
Full title
A method validation, single-period, open-label evaluation study to explore the sensitivity of a novel biosensor device (SenseWear® Armband Gecko) for measuring physical activity in subjects with COPD & Asthma
IRAS ID
181307
Contact name
Disala Fernando
Contact email
Sponsor organisation
GlaxoSmithKline Clinical Unit Cambridge, CPSSO
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
This study is to record the physical activity (e.g. steps taken and estimated calories burned) in subjects with diagnosed Chronic Obstructive Pulmonary Disease (COPD) and Asthma, with the help of new and previously tested versions of electronic measurement devices, which will be worn on the wrist and upper arm.
The results of this study will help to better understand the impact of COPD and asthma, and the current medication the patients are taking, on their physical activity. Further, the information collected will help a new generation measurement device to be compared to its previous version.
There are 2 groups in this study, 10 subjects with COPD and 10 with asthma. Subjects will be admitted to the GSK clinical unit on Day 1 and spend a minimum of 24 hours at the unit wearing the physical activity monitor devices and participating in a series of exercises i.e. walking on a treadmill.
There will be an option for the patients to consent to wear a sleep monitor overnight which will be attached to the chest with a strap and electrodes attached to the head, with tape or paste, to monitor sleep. This will allow continuous assessment of device performance in sleep as well as during exercise. Blood samples will be taken to see if any changes happen to the blood cells at different times during the day. A follow-up phone call will occur up to 96 hours following completion of the study visit.
All participants will be admitted to a specialist clinical research unit with adequate safety and compliance facilities for conducting this research. Taking part in the study will not have direct benefit to participants. Results from this study will support the design of future studies using this technology.The study is sponsored by GlaxoSmithKline and disclosed on http://www.gsk-clinicalstudyregister.com/.
REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/1143
Date of REC Opinion
23 Jul 2015
REC opinion
Further Information Favourable Opinion