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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02909738
Other study ID # IRB_00089531
Secondary ID
Status Completed
Phase N/A
First received September 16, 2016
Last updated April 26, 2017
Start date August 2016
Est. completion date April 2017

Study information

Verified date April 2017
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The investigators would like to test how many healthy people can power the oxygen concentrator by pedaling the bike for at least 30 minutes. If the healthy volunteers can bike for at least 30 minutes, the investigators assume they are pedaling at or below their lactate threshold. The investigators have literature values which suggest bigger people should be able to output more work, and the investigators wish to use a sample of the population to verify that most of the people can power our system. The investigators have a good estimate of the power required by our system, and the investigators want to verify the average person can actually do what we calculated is necessary.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 1)anyone with known cardiovascular, pulmonary, or metabolic disease or

2)an age of greater than 45 or

3) 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Volunteer to pedal a bicycle


Locations

Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Capable of pedaling the bike for 30 minutes 30 minutes from the start time
Primary Average heart rate Average for the 30 minute pedaling session
Primary volume of oxygen generated 30 minutes
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