Simulated Passive Jogging & Jumping Devices & NO

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426774
• Other study ID #: GJHP2017
• Secondary ID: 20170208
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: January 23, 2020

Study information

• Verified date: April 2019
• Source: Sackner Wellness Products LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• 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:

• Age greater than 25 yrs

• Able to provide Informed Consent

Exclusion Criteria:

• Age less than 25 yrs

• Not able to provide informed consent

Related Conditions & MeSH terms

• Blood Pressure
• Physical Activity

Intervention

Device:
• Gentle Jogger
Passive Simulated Jogging device (Gentle Jogger)
• Gentle Jumper
Passive Simulated Jumping Device ( Gentle Jumper)

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	a/b ratio from Photoplethysmogragh	Determination of the change in a/b ratio from the non invasively acquired arterial pulse waveform	3 hr
Secondary	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