Gentle Jogger and Oxygen Consumption

January 23, 2020 updated by: Sackner Wellness Products LLC

Effects of Gentle Jogger on Oxygen Consumption

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

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

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • CIC Miami

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

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OXYGEN CONSUMPTION SINGLE ARM
Single arm Study Volunteer will h lie in supine posture for 20 min and oxygen consumption(VO2) will be measured in duplicate. Gentle Jogger (GJ) will be started in supine posture for 20 min and VO2 measured again in duplicate. The subject will be asked to sit in a chair for 20 min and VO2 will be measured in duplicate. Gentle Jogger (GJ) will be started in seated posture for 20 min and VO2 measured again in duplicate.
Device: Gentle Jogger (GJ)
Gentle jogger is a passive jogging device which passively moves the feet up and down simulating jogging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Rest in Oxygen Consumption
Time Frame: After 20 min of Rest and after 20 min of Gentle Jogger
oxygen consumption measured by indirect calorimetry
After 20 min of Rest and after 20 min of Gentle Jogger

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sackner Wellness Products LLC

Investigators

  • Study Director: Marvin Sackner, MD, CEO Sackner Wellness
  • Principal Investigator: Jose A Adams, MD, Director of Research Sackner Wellness

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 1, 2018

Primary Completion (Actual)

January 23, 2020

Study Completion (Actual)

January 23, 2020

Study Registration Dates

First Submitted

July 18, 2018

First Submitted That Met QC Criteria

July 18, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GJHP2017COMP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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