Simulated Passive Jogging & Jumping Devices & NO

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Physical Activity, Blood Pressure

Intervention / Treatment
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* Device: Gentle Jogger
* Device: Gentle Jumper


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Evaluation of the effects of GentleJogger and Gentle Jumper on noninvasive biometric data in various postures in two specify age groups a) Younger 25-59 yrs b) Older > 60 yrs Each Subject will serve as his or her own Sham Control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YG ( 25-59yrs) -GJogger<br>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<br>* Passive Simulated Jogging device (Gentle Jogger)<br>|
| Experimental: OG (Greater than 60 yrs)-GJogger<br>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<br>* Passive Simulated Jogging device (Gentle Jogger)<br>|
| Experimental: YG ( 25-59yrs) -GJumper<br>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<br>* Passive Simulated Jumping Device ( Gentle Jumper)<br>|
| Experimental: OG (Greater than 60 yrs)-Gjumper<br>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<br>* Passive Simulated Jumping Device ( Gentle Jumper)<br>|
| Sham Comparator: YG ( 25-59yrs) -GJogger Sham<br>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<br>* Passive Simulated Jogging device (Gentle Jogger)<br>|
| Sham Comparator: OG (Greater than 60 yrs)- GJogger-Sham<br>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<br>* Passive Simulated Jogging device (Gentle Jogger)<br>|
| Sham Comparator: YG ( 25-59yrs) -GJumper- Sham<br>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<br>* Passive Simulated Jumping Device ( Gentle Jumper)<br>|
| Sham Comparator: OG (Greater than 60 yrs)-GJumper Sham<br>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<br>* Passive Simulated Jumping Device ( Gentle Jumper)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a/b ratio from Photoplethysmogragh | 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 | Determination of the changes in non invasively acquired continous blood pressure during and after use of the device in various postures | 3 hr |