Physical ActivityNCT03426774
Simulated Passive Jogging & Jumping Devices & NO
A study testing Gentle Jogger and Gentle Jumper in people with Physical Activity and Blood Pressure, run by Sackner Wellness Products LLC at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Blood Pressure
- What is being tested?
- Gentle Jogger and Gentle Jumper
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 23 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than 25 yrs
- Able to provide Informed Consent
Who cannot join
- Age less than 25 yrs
- Not able to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive Determination of Nitric Oxide Release by Simulated Passive Jogging & Jumping Devices
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.
- Conditions
- Physical Activity, Blood Pressure
- Being tested
- Gentle Jogger, Gentle Jumper
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle JoggerDevice
Passive Simulated Jogging device (Gentle Jogger)
Gentle JumperDevice
Passive Simulated Jumping Device ( Gentle Jumper)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Gentle Jumper |
What is being measured
The primary outcome is the main question the study is designed to answer.
a/b ratio from Photoplethysmogragh
Determination of the change in a/b ratio from the non invasively acquired arterial pulse waveform
Measured: 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
Measured: 3 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start1 Mar 2017
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sackner Wellness Products LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose A Adams, M.D., Principal investigator, Sackner Wellness Products LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426774
- Sponsor's protocol ID
- GJHP2017
- Other IDs
- 20170208
- Status last verified
- Apr 2019
- First submitted
- 25 Jan 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 35924333Sackner 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Determination of Nitric Oxide Release by Simulated Passive Jogging & Jumping Devices
- ClinicalTrials.gov ID
- NCT03426774
- Acronym / sponsor ID
- GJHP2017
- Conditions
- Physical Activity, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Sackner Wellness Products LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
- 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
| Arm | Type | Receives |
|---|---|---|
| YG ( 25-59yrs) -GJogger | Experimental | Device: Gentle JoggerGentle 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. |
| OG (Greater than 60 yrs)-GJogger | Experimental | Device: Gentle JoggerGentle 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. |
| YG ( 25-59yrs) -GJumper | Experimental | Device: Gentle JumperGentle 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. |
| OG (Greater than 60 yrs)-Gjumper | Experimental | Device: Gentle JumperGentle 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. |
| YG ( 25-59yrs) -GJogger Sham | Sham comparator | Device: Gentle JoggerA 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. |
| OG (Greater than 60 yrs)- GJogger-Sham | Sham comparator | Device: Gentle JoggerA 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. |
| YG ( 25-59yrs) -GJumper- Sham | Sham comparator | Device: Gentle JumperA 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. |
| OG (Greater than 60 yrs)-GJumper Sham | Sham comparator | Device: Gentle JumperA 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than 25 yrs
- Able to provide Informed Consent
Key exclusion criteria (2 listed)
- Age less than 25 yrs
- Not able to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gentle JoggerPassive Simulated Jogging device (Gentle Jogger) | Device | OG (Greater than 60 yrs)- GJogger-Sham, OG (Greater than 60 yrs)-GJogger, YG ( 25-59yrs) -GJogger, YG ( 25-59yrs) -GJogger Sham |
| Gentle JumperPassive Simulated Jumping Device ( Gentle Jumper) | Device | OG (Greater than 60 yrs)-GJumper Sham, OG (Greater than 60 yrs)-Gjumper, YG ( 25-59yrs) -GJumper, YG ( 25-59yrs) -GJumper- Sham |
Primary outcome
a/b ratio from Photoplethysmogragh
Time frame: 3 hr
Determination of the change in a/b ratio from the non invasively acquired arterial pulse waveform
1 secondary outcome
Blood Pressure Changes
Time frame: 3 hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 35924333Adams 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.
- Derived from this study: PubMed 30350153Sackner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose A Adams, M.D. principal investigator
Sackner Wellness Products LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gentle Jogger and Gentle Jumper in people with Physical Activity and Blood Pressure, run by Sackner Wellness Products LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a/b ratio from Photoplethysmogragh (time frame: 3 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03426774, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.