NCT02909738

Brief Summary

The investigators would like to test how well healthy human volunteers power a modified oxygen concentrator. The investigators modified the oxygen concentrator to be powered by a bicycle instead of wall power so that it can be used in low resource countries where the power supply is unreliable.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

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

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

September 16, 2016

Last Update Submit

April 26, 2017

Conditions

Physical Exertion

Outcome Measures

Primary Outcomes (3)

  • Capable of pedaling the bike for 30 minutes

    30 minutes from the start time

  • Average heart rate

    Average for the 30 minute pedaling session

  • volume of oxygen generated

    30 minutes

Study Arms (1)

Volunteers

Healthy volunteers willing to pedal a bike for 30 minutes.

Other: Volunteer to pedal a bicycle

Interventions

Volunteer to pedal a bicycleOTHER
Volunteers

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Volunteers will be included if they are between 18 and 45 years of age and if they do not have physical restrictions which would preclude them from riding a bike for 30 minutes.

You may not qualify if:

  • )anyone with known cardiovascular, pulmonary, or metabolic disease or
  • )an age of greater than 45 or
  • \) one or more of the following symptoms:
  • On medication for their heart
  • Suffer from pains in their chest
  • Ever feel faint of have spells of severe dizziness
  • High blood pressure
  • Currently on blood pressure medication
  • Have a bone or joint problem such as arthritis that has been aggravated by exercise
  • Unaccustomed to vigorous exercise
  • Have experienced unusual heart beats such as skipped beats or palpitations
  • Experience shortness or loss of breath while walking with others your own age
  • Have been diagnosed with diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84105, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

September 16, 2016

First Posted

September 21, 2016

Study Start

August 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 28, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)