NCT03426774

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2020

Completed
Last Updated

January 27, 2020

Status Verified

April 1, 2019

Enrollment Period

2.9 years

First QC Date

January 25, 2018

Last Update Submit

January 23, 2020

Conditions

Physical ActivityBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • a/b ratio from Photoplethysmogragh

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

    3 hr

Secondary Outcomes (1)

  • Blood Pressure Changes

    3 hr

Study Arms (8)

YG ( 25-59yrs) -GJogger

EXPERIMENTAL

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

OG (Greater than 60 yrs)-GJogger

EXPERIMENTAL

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

YG ( 25-59yrs) -GJumper

EXPERIMENTAL

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

OG (Greater than 60 yrs)-Gjumper

EXPERIMENTAL

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

YG ( 25-59yrs) -GJogger Sham

SHAM COMPARATOR

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

OG (Greater than 60 yrs)- GJogger-Sham

SHAM COMPARATOR

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

YG ( 25-59yrs) -GJumper- Sham

SHAM COMPARATOR

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

OG (Greater than 60 yrs)-GJumper Sham

SHAM COMPARATOR

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

Gentle JoggerDEVICE

Passive Simulated Jogging device (Gentle Jogger)

OG (Greater than 60 yrs)- GJogger-ShamOG (Greater than 60 yrs)-GJoggerYG ( 25-59yrs) -GJoggerYG ( 25-59yrs) -GJogger Sham
Gentle JumperDEVICE

Passive Simulated Jumping Device ( Gentle Jumper)

OG (Greater than 60 yrs)-GJumper ShamOG (Greater than 60 yrs)-GjumperYG ( 25-59yrs) -GJumperYG ( 25-59yrs) -GJumper- Sham

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 25 yrs
  • Able to provide Informed Consent

You may not qualify if:

  • Age less than 25 yrs
  • Not able to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC Miami

Miami, Florida, 33136, United States

Location

Related Publications (2)

  • 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.

    PMID: 35924333DERIVED

  • 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.

    PMID: 30350153DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jose A Adams, M.D.

    Sackner Wellness Products LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 8, 2018

Study Start

March 1, 2017

Primary Completion

January 23, 2020

Study Completion

January 23, 2020

Last Updated

January 27, 2020

Record last verified: 2019-04

Locations

US(1)