Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The prevalence, low cost, and low burden of wearable devices that provide quantitative and
      qualitative feedback on a subject's activity level present an opportunity for the use of
      these devices in clinical and observational studies. However, the accuracy and
      reproducibility of any given device may vary with device design and algorithm implementation.
      Therefore, validation of emerging technologies against known standards such as analysis of
      exhaled breath and currently available medical devices is critical. This is a single center,
      two-cohort, single period, open-label, methodology study. No investigational product will be
      used in this study. Eligible subjects will wear 2 generations of SenseWear Armband devices, 2
      ActiGraph GT9x devices (one on the wrist and one on the waist) and a Garmin Vivofit 2
      activity tracker wristband for up to 24 hours per day. Subjects who consent to participate in
      an optional sub-study will wear a SOMNOwatch Plus EEG-6 device while sleeping. Subjects will
      perform a variety of laboratory and field-based exercise tests and strength exercises using
      Latex-Free Therabands.The co-primary objectives of this study are firstly to compare the
      outputs of the test devices (SenseWear Armband Gecko and Actigraph GT9x) to those of the
      SenseWear Armband MF and secondly to assess the sensitivity and accuracy of the test devices
      in subjects with COPD or asthma while performing laboratory-based exercise testing.
    


Intervention name(s): SenseWear Armband Gecko; SenseWear Armband MF; Actigraph GT9x wristband and waistband; Garmin Vivofit 2 wristband; SOMNOwatch plus EEG 6 sleep monitor; Strength exercises; Field-based exercise tests; Laboratory-based exercise tests
Intervention type(s): Device; Device; Device; Device; Device; Other; Other; Other
Intervention description(s): Subjects will wear SenseWear Armband Gecko up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests; Subjects will wear SenseWear Armband MF up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests; Subjects will wear Actigraph GT9x wristband and waistband up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests; Subjects will wear Garmin Vivofit 2 wristband up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests; In a subset of subjects, this device will be worn as a comparator for monitoring sleep quality and duration.; Subjects will perform strength exercises using elastic bands of varying resistance; Subjects will perform an Incremental Shuttle Walk Test (ISWT) and each individual component of a Short Physical Performance Battery (SPPB).; Subjects will perform an incremental, symptom-limited cardiopulmonary exercise test on a cycle ergometer and will walk at various speeds on a treadmill
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Asthma; wearable physical activity monitor; step counts; Exercise; energy expenditure; COPD; indirect calorimetry