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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 10 subjects diagnosed with COPD (GOLD stages 2 and 3). Subjects will wear multiple devices simultaneously (SenseWear Armband Gecko, SenseWear Armband MF, Actigraph GT9x wristband and waistband and 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. |
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| Cohort 2 | Experimental | 10 subjects diagnosed with asthma. Subjects will wear multiple devices simultaneously (SenseWear Armband Gecko, SenseWear Armband MF, Actigraph GT9x wristband and waistband and 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SenseWear Armband Gecko | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Energy expenditure [kilocalories per minute] | Energy expenditure will be assessed by test devices at various levels of exertion during field-based and laboratory-based exercise tests. Graphical and/or statistical comparisons will be made between test devices and with information derived from indirect calorimetry obtained by exhaled gas analysis, where available. | Up to Day 2 |
| Energy expenditure [metabolic equivalents] | Energy expenditure will be assessed by test devices at various levels of exertion during field-based and laboratory-based exercise tests. Graphical and/or statistical comparisons will be made between test devices and with information derived from indirect calorimetry obtained by exhaled gas analysis, where available. | Up to Day 2 |
| Step counts [total number of steps taken] | Step counts will be collected by test devices at various levels of exertion during field-based and laboratory-based exercise tests. Graphical and/or statistical comparisons will be made between devices and with manually counted steps, where available. | Up to Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events (AE) or serious adverse events (SAE). | AEs and SAEs will be collected for each subject from the start of study until the follow-up contact | From the start of Study procedures until follow-up (6 days) |
| Number of subjects with abnormal vital signs related to interventions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cambridge | CB2 2GG | United Kingdom |
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| Label | URL |
|---|---|
| Results for study 202373 can be found on the GSK Clinical Study Register. | View source |
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| SenseWear Armband MF | Device | 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 |
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| Actigraph GT9x wristband and waistband | Device | 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 |
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| Garmin Vivofit 2 wristband | Device | 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 |
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| SOMNOwatch plus EEG 6 sleep monitor | Device | In a subset of subjects, this device will be worn as a comparator for monitoring sleep quality and duration. |
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| Strength exercises | Other | Subjects will perform strength exercises using elastic bands of varying resistance |
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| Field-based exercise tests | Other | Subjects will perform an Incremental Shuttle Walk Test (ISWT) and each individual component of a Short Physical Performance Battery (SPPB). |
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| Laboratory-based exercise tests | Other | Subjects will perform an incremental, symptom-limited cardiopulmonary exercise test on a cycle ergometer and will walk at various speeds on a treadmill |
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Oral temperature (degrees Celsius), systolic and diastolic blood pressure (mmHg), heart rate (beats per minute), respiratory rate (breaths per minute), and oxygen saturation (percent) will be collected at various times throughout the study. |
| Screening and Days 1 and 2 |
| Forced Expiratory Volume in 1 second (FEV1) | Post-salbutamol spirometry will be obtained at screening, if necessary. Post- salbutamol FEV1 will be determined. | Screening |
| Ratio of FEV1 and Forced Vital Capacity (FVC) | Ratio of FEV1 and Forced Vital Capacity (FVC) will be determined at screening. | Screening |
| Borg dyspnea index score | Borg dyspnea scores will be obtained during and after exercise. | Days 1 and 2 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
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