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NCT03602365 Clinical Trial

Gentle Jogger and Oxygen Consumption

Physical Inactivity Clinical Trial

Official title:
Effects of Gentle Jogger on Oxygen Consumption

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03602365
Other study ID # GJHP2017COMP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date January 23, 2020

Study information
Verified date September 2019
Source Sackner Wellness Products LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a non randomized study to determine the effects of Gentle Jogger(GJ), a passive jogging device on oxygen consumption in 2 postures supine and seated. Oxygen consumption measurements will be performed via indirect calorimetry in duplicate at rest ( supine and seated posture) , and repeated in duplicate during GJ (in supine and seated posture)

Description:

The Gentle Jogger (GJ) is a patented non-FDA regulated wellness device in which GJ; 1) as part of a healthy lifestyle may help prevent certain chronic diseases or conditions such as heart disease, high blood pressure, and type 2 diabetes and 2) may help living well with certain chronic diseases or conditions such as heart disease, high blood pressure and type 2 diabetes. GJ is a passive simulated jogging device which moves the feet up and down passively, simulating jogging. GJ addresses the major health problem of physical inactivity.

This is a non randomized study of adult subjects on the effects of Gentle Jogger (GJ) on resting oxygen consumption (VO2).

This study will determine whether or not the use of GJ in either sitting or supine postures changes resting oxygen consumption, measured using indirect calorimetry method.

Potential study subjects will be invited to participate, and informed consent obtained from each subject.

Each subject will me asked to lie in supine posture for 20 mins followed by duplicate measurements of VO2. The GJ will be started in supine posture for 20 min followed by duplicate measurements of VO2. The subject will then be asked to sit in a chair for 20 min, followed by duplicate measurement of VO2, The GJ will be started for 20 min in seated posture followed by duplicate measurements of VO2.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date January 23, 2020
Est. primary completion date January 23, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years and older
Eligibility Inclusion Criteria:

- Adult subjects > 25 yrs old

Exclusion Criteria:

- Unable to provide informed consent

- Inability to follow command

- Physically unable to move feet up and down on a gentle jogger

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Gentle Jogger (GJ)
Gentle jogger is a passive jogging device which passively moves the feet up and down simulating jogging

Locations
Country Name City State
United States CIC Miami Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
Sackner Wellness Products LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Rest in Oxygen Consumption oxygen consumption measured by indirect calorimetry After 20 min of Rest and after 20 min of Gentle Jogger
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