Simulated Passive Jogging & Jumping Devices & NO

S

Sackner Wellness Products

Status

Completed

Conditions

Physical Activity
Blood Pressure

Treatments

Device: Gentle Jumper
Device: Gentle Jogger

Study type

Interventional

Funder types

Industry

Identifiers

NCT03426774
GJHP2017
20170208

Details and patient eligibility

About

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

Full 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.

Enrollment

22 patients

Sex

All

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

22 participants in 8 patient groups

YG ( 25-59yrs) -GJogger
Experimental group
Description:
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.
Treatment:
Device: Gentle Jogger
OG (Greater than 60 yrs)-GJogger
Experimental group
Description:
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.
Treatment:
Device: Gentle Jogger
YG ( 25-59yrs) -GJumper
Experimental group
Description:
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.
Treatment:
Device: Gentle Jumper
OG (Greater than 60 yrs)-Gjumper
Experimental group
Description:
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.
Treatment:
Device: Gentle Jumper
YG ( 25-59yrs) -GJogger Sham
Sham Comparator group
Description:
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.
Treatment:
Device: Gentle Jogger
OG (Greater than 60 yrs)- GJogger-Sham
Sham Comparator group
Description:
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.
Treatment:
Device: Gentle Jogger
YG ( 25-59yrs) -GJumper- Sham
Sham Comparator group
Description:
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.
Treatment:
Device: Gentle Jumper
OG (Greater than 60 yrs)-GJumper Sham
Sham Comparator group
Description:
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.
Treatment:
Device: Gentle Jumper

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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