- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02909738
Measuring Ability of Healthy Volunteers to Power a Bicycle-powered Oxygen Concentrator
April 26, 2017 updated by: Lara Brewer, University of Utah
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84105
- University of Utah
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy volunteers
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Volunteers
Healthy volunteers willing to pedal a bike for 30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Capable of pedaling the bike for 30 minutes
Time Frame: 30 minutes from the start time
|
30 minutes from the start time
|
|
Average heart rate
Time Frame: Average for the 30 minute pedaling session
|
Average for the 30 minute pedaling session
|
|
volume of oxygen generated
Time Frame: 30 minutes
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
September 16, 2016
First Submitted That Met QC Criteria
September 16, 2016
First Posted (Estimate)
September 21, 2016
Study Record Updates
Last Update Posted (Actual)
April 28, 2017
Last Update Submitted That Met QC Criteria
April 26, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- IRB_00089531
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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