Simulated Passive Jogging & Jumping Devices & NO



Status:Active, not recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:25 - Any
Updated:4/6/2019
Start Date:March 1, 2017
End Date:March 1, 2020

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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

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.

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
We found this trial at
1
site
Miami, Florida 33136
?
mi
from
Miami, FL
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