Simulated Passive Jogging & Jumping Devices & NO

January 23, 2020 updated by: Sackner Wellness Products LLC

Non-Invasive Determination of Nitric Oxide Release by Simulated Passive Jogging & Jumping Devices

Movement is important for overall health. Lack of movement has been shown to be associated with numerous diseases. This study will assess the validity and usefulness of two innovative low risk, non-invasive wellness devices, the Gentle Jogger® and the Gentle Jumper that passively simulate the physical activities of jogging and jumping, respectively. The study will evaluate whether or not each of the devices in different body postures (seated, lying down, slight recumbent and slight head down) produces changes in blood pressure, and indices of dilatation of blood vessels, in a younger (25-59yr) and older (> 60 yrs.) subject population. Volunteers will be paid for their participation in the study.

A substudy of this larger study ( Effects of Gentle Jogger on blood pressure), will determine the effects of 30 min of gentle jogger in seated and supine posture compared to Sham

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Physical inactivity is a significant risk for various cardiovascular diseases including hypertension, diabetes, and stroke. To address the sitting disease Sackner Wellness Products has patented 2 non-invasive methods for inducing passive movement while in seated or supine posture the Gentle Jogger® and Gentle Jumper®, each simulating the activities of jogging and jumping respectively. Passive simulation of jogging and jumping introduces pulses into the circulation as the feet strike a semi-rigid surface within the chassis of the device. These pulsations stimulate release of beneficial mediators which are important to cardiovascular health. The study will recruit healthy subjects in a younger age group (25-59 yrs ) and older age group (> 60 yrs) in order to measure changes in blood pressure, cardiovascular indices of vasodilation, heart rate variability, and other non-invasively acquired biometric information in different postures [(1) supine, 2) semi-recumbent, 3) sitting, 4) Trendelenburg and 5) reverse Trendelenburg )], while at rest and during and after use of the GJogger and GJumper. Additionally, a subgroup of subjects will be asked to perform texting of a specified script in order to determine whether or not GJogger is a distraction during text messaging.

Participants will also be recruited for a sub-study of the above larger study. This sub-study will determine the effects of a single device Gentle Jogger in setaed and supine posture over a 30 min period on continuously measured non-invasive blood pressure, and compared the latter to SHAM. On day 1 Subjects will be randomized to begin in seated or supine posture with 30 min of SHAM, and 30 min of Gentle Jogger, 3 days latter the subject will cross over to start with the opposite posture of day 1.

This study will determine the effects of 30 min of sedentary supine or seated (SHAM) and the effects of 30 min of G. Jogger in these two postures on continuous noninvasive measured blood pressure

Volunteers will be paid for their participation in the study The Gentle Jogger and Gentle Jumper are non-FDA regulated wellness devices (2016) in which, 1) GJogger and GJumper as part of a healthy lifestyle may help to 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 s heart disease, high blood pressure, and type 2 diabetes.

Study Type

Interventional

Enrollment (Actual)

22

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age greater than 25 yrs
  • Able to provide Informed Consent

Exclusion Criteria:

  • Age less than 25 yrs
  • Not able to provide informed consent

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: YG ( 25-59yrs) -GJogger
Gentle Jogger applied to each individual in 1) supine, 2) semi-recumbent, 3) sitting, 4) Trendelenburg and 5) reverse Trendelenburg Each Subject serves as his/her own control.
Device: Gentle Jogger
Passive Simulated Jogging device (Gentle Jogger)
Experimental: OG (Greater than 60 yrs)-GJogger
Gentle Jogger applied to each individual in (1) supine, 2) semi-recumbent, 3) sitting, 4) Trendelenburg and 5) reverse Trendelenburg Each Subject serves as his/her own control.
Device: Gentle Jogger
Passive Simulated Jogging device (Gentle Jogger)
Experimental: YG ( 25-59yrs) -GJumper
Gentle Jumper applied to each individual in 1) supine, 2) semi-recumbent, 3) sitting, 4) Trendelenburg and 5) reverse Trendelenburg Each Subject serves as his/her own control.
Device: Gentle Jumper
Passive Simulated Jumping Device ( Gentle Jumper)
Experimental: OG (Greater than 60 yrs)-Gjumper
Gentle Jumper applied to each individual in 1) supine, 2) semi-recumbent, 3) sitting, 4) Trendelenburg and 5) reverse Trendelenburg Each Subject serves as his/her own control.
Device: Gentle Jumper
Passive Simulated Jumping Device ( Gentle Jumper)
Sham Comparator: YG ( 25-59yrs) -GJogger Sham
A Sham Gentle Jogger is applied to each individual in 1) supine, 2) semi-recumbent, 3) sitting, 4) Trendelenburg and 5) reverse Trendelenburg Each Subject serves as his/her own control.
Device: Gentle Jogger
Passive Simulated Jogging device (Gentle Jogger)
Sham Comparator: OG (Greater than 60 yrs)- GJogger-Sham
A Sham Gentle Jogger is applied to each individual in 1) supine, 2) semi-recumbent, 3) sitting, 4) Trendelenburg and 5) reverse Trendelenburg Each Subject serves as his/her own control.
Device: Gentle Jogger
Passive Simulated Jogging device (Gentle Jogger)
Sham Comparator: YG ( 25-59yrs) -GJumper- Sham
A Sham Gentle Jumper is applied to each individual in 1) supine, 2) semi-recumbent, 3) sitting, 4) Trendelenburg and 5) reverse Trendelenburg Each Subject serves as his/her own control.
Device: Gentle Jumper
Passive Simulated Jumping Device ( Gentle Jumper)
Sham Comparator: OG (Greater than 60 yrs)-GJumper Sham
A Sham Gentle Jumper is applied to each individual in 1) supine, 2) semi-recumbent, 3) sitting, 4) Trendelenburg and 5) reverse Trendelenburg Each Subject serves as his/her own control.
Device: Gentle Jumper
Passive Simulated Jumping Device ( Gentle Jumper)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
a/b ratio from Photoplethysmogragh
Time Frame: 3 hr
Determination of the change in a/b ratio from the non invasively acquired arterial pulse waveform
3 hr

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure Changes
Time Frame: 3 hr
Determination of the changes in non invasively acquired continous blood pressure during and after use of the device in various postures
3 hr

Collaborators and Investigators

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

Sponsor

Sackner Wellness Products LLC

Investigators

  • Principal Investigator: Jose A Adams, M.D., Sackner Wellness Products LLC

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)

March 1, 2017

Primary Completion (Actual)

January 23, 2020

Study Completion (Actual)

January 23, 2020

Study Registration Dates

First Submitted

January 25, 2018

First Submitted That Met QC Criteria

February 2, 2018

First Posted (Actual)

February 8, 2018

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • GJHP2017
  • 20170208 (WIRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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