COPD, Obesity
Conditions
Brief summary
The purpose of this study is to determine whether muscle activation can be accomplished more effectively and comfortably in challenging subjects using novel configurations of an activation device. A novel device will be compared side by side with a market leading device.
Interventions
DEVICEMuscle Activation with Niveus and Intelect Devices
Subjects will receive muscle activation technology from the Niveus device on one leg and from the Intelect (commercially-available third-party) device on the other. The order of use and the leg applied to will be randomized.
Sponsors
Niveus Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* BMI \> 30 (Wing 1 of study) * Non-hospitalized with confirmed diagnosis of COPD (Wing 2 of study)
Exclusion criteria
* Age \< 18 years * Subject has an implanted pacemaker/defibrillator * Subject diagnosed with epilepsy * Subject has implanted metallic femoral rods * Subject is chair- or bed-bound * Subject has neuromuscular disease or abnormalities * Subject BMI \> 45 * Evidence of disease or condition that, in the opinion of the investigator, may compromise the conduct of or results of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity Required | During treatment | Intensity required to achieve target levels of muscle contraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | During treatment | Comfort of stimulation will be assessed at various intensity levels using a widely-used discomfort scale |
Countries
United States
Outcome results
None listed