ClinicalTrials.gg
CompletedNCT03426774Updated Jan 27, 2020

Simulated Passive Jogging & Jumping Devices & NO

An interventional study of Gentle Jogger and Gentle Jumper in Physical Activity and Blood Pressure, sponsored by Sackner Wellness Products LLC. Completed at 1 site in United States. Open to participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-27.

Sponsored by Sackner Wellness Products LLC · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Mar 2017, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
25 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 2,858 studies in Motor Activity with a site in United States — 423 open to participants now, 564 under way, 9 of them phase 3. Motor Activity · United States.

Enrollment
2,059th of 2,605
22 · median 55
Started
2017
with 159 others
No phase
2,243 of 2,858
353 open now
Registered
1,419th of 2,858
by date

Among the 2,858 studies in Motor Activity with a site in United States, this one is the 2,059th largest by enrollment of the 2,605 interventional ones that give a count, is one of 160 that started in 2017, is one of 2,243 with no phase, and was the 1,419th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

423 of the 2,858 studies in Motor Activity with a site in United States are open now. Recruiting first, the newest first:

418 more — sign in →

All 423 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 25 Years and older · all sexes · healthy volunteers too.

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02

Study 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

Read the 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.

03

Conditions studied

  • Physical Activity
  • Blood Pressure

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04

Who can participate

Ages eligible
25 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age greater than 25 yrs
  • Able to provide

Exclusion criteria

Exclusion Criteria:

  • Age less than 25 yrs
  • Not able to provide
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • DeviceGentle Jogger

    Passive Simulated Jogging device (Gentle Jogger)

  • DeviceGentle Jumper

    Passive Simulated Jumping Device ( Gentle Jumper)

06

What researchers measure

Primary outcomes

  1. a/b ratio from Photoplethysmogragh

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

    Time frame: 3 hr

Secondary outcomes

  1. Blood Pressure Changes

    Determination of the changes in non invasively acquired continous blood pressure during and after use of the device in various postures

    Time frame: 3 hr

07

Study locations

1 site
  • CIC Miami
    Miami, Florida 33136, United States
08

References and documents

Publications

  • Adams JA, Lopez JR, Nadkarni V, Zolkipli-Cunningham Z, Ischiropoulos H, Sackner MA. The effects of a motorized passive simulated jogging device on descent of the arterial pulse waveform dicrotic notch: A single arm placebo-controlled cross-over trial. Physiol Rep. 2022 Aug;10(15):e15418. doi: 10.14814/phy2.15418. PubMed 35924333 ↗
  • Sackner MA, Patel S, Adams JA. Changes of blood pressure following initiation of physical inactivity and after external addition of pulses to circulation. Eur J Appl Physiol. 2019 Jan;119(1):201-211. doi: 10.1007/s00421-018-4016-7. Epub 2018 Oct 22. PubMed 30350153 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2017 to primary completion in Jan 2020, 34 months.

Of 60 industry-sponsored interventional studies with no phase under Motor Activity, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's 34 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2018
First posted
Feb 8, 2018
StartActual
Mar 1, 2017
Primary completionActual
Jan 23, 2020
CompletionActual
Jan 23, 2020
Last update
Jan 27, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03426774
Lead sponsor
Sackner Wellness Products LLC
Responsible party
Sponsor
First posted
Feb 8, 2018
Start date
Mar 1, 2017
Primary completion
Jan 23, 2020
Completion
Jan 23, 2020
Last update
Jan 27, 2020

Study contacts

Jose A Adams, M.D.
principal investigator · Sackner Wellness Products LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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