NCT01811446

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

6 months

First QC Date

March 12, 2013

Last Update Submit

January 29, 2014

Conditions

ObesityCOPD

Outcome Measures

Primary Outcomes (1)

  • Intensity Required

    Intensity required to achieve target levels of muscle contraction

    During treatment

Secondary Outcomes (1)

  • Comfort

    During treatment

Study Arms (2)

Obese

EXPERIMENTAL

Subjects with BMI \> 30

Device: Muscle Activation with Niveus and Intelect Devices

COPD

EXPERIMENTAL

Non-hospitalized COPD patients

Device: Muscle Activation with Niveus and Intelect Devices

Interventions

Muscle Activation with Niveus and Intelect DevicesDEVICE

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.

COPDObese

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 30 (Wing 1 of study)
  • Non-hospitalized with confirmed diagnosis of COPD (Wing 2 of study)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fogarty Clinical Research

Mountain View, California, 94040, United States

Location

MeSH Terms

Conditions

ObesityPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic Processes

Study Officials

  • Bahman Nouri, MD

    El Camino Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2013

First Posted

March 14, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2013

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

US(1)