Physical InactivityNCT03602365
Gentle Jogger and Oxygen Consumption
A study testing Gentle Jogger (GJ) in people with Physical Inactivity and Oxygen Consumption, run by Sackner Wellness Products LLC at 1 site in United States.
Trial summary
This is a non randomized study to determine the effects of Gentle Jogger(GJ), a passive jogging device on oxygen consumption in 2 postures supine and seated. Oxygen consumption measurements will be performed via indirect calorimetry in duplicate at rest ( supine and seated posture) , and repeated in duplicate during… Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Oxygen Consumption
- What is being tested?
- Gentle Jogger (GJ)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 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
- Adult subjects > 25 yrs old
Who cannot join
- Unable to provide informed consent
- Inability to follow command
- Physically unable to move feet up and down on a gentle jogger
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Gentle Jogger on Oxygen Consumption
This is a non randomized study to determine the effects of Gentle Jogger(GJ), a passive jogging device on oxygen consumption in 2 postures supine and seated. Oxygen consumption measurements will be performed via indirect calorimetry in duplicate at rest ( supine and seated posture) , and repeated in duplicate during GJ (in supine and seated posture)
Read the detailed description
The Gentle Jogger (GJ) is a patented non-FDA regulated wellness device in which GJ; 1) as part of a healthy lifestyle may help 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 heart disease, high blood pressure and type 2 diabetes. GJ is a passive simulated jogging device which moves the feet up and down passively, simulating jogging. GJ addresses the major health problem of physical inactivity.
This is a non randomized study of adult subjects on the effects of Gentle Jogger (GJ) on resting oxygen consumption (VO2).
This study will determine whether or not the use of GJ in either sitting or supine postures changes resting oxygen consumption, measured using indirect calorimetry method.
Potential study subjects will be invited to participate, and informed consent obtained from each subject.
Each subject will me asked to lie in supine posture for 20 mins followed by duplicate measurements of VO2. The GJ will be started in supine posture for 20 min followed by duplicate measurements of VO2. The subject will then be asked to sit in a chair for 20 min, followed by duplicate measurement of VO2, The GJ will be started for 20 min in seated posture followed by duplicate measurements of VO2.
- Conditions
- Physical Inactivity, Oxygen Consumption
- Being tested
- Gentle Jogger (GJ)
- Keywords
- Oxygen Consumption, Physical Activity, Passive Motion
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle Jogger (GJ)Device
Gentle jogger is a passive jogging device which passively moves the feet up and down simulating jogging
| Study group | Role | What they receive |
|---|---|---|
| OXYGEN CONSUMPTION SINGLE ARM | Experimental | Single arm Study Volunteer will h lie in supine posture for 20 min and oxygen consumption(VO2) will be measured in duplicate. Gentle Jogger (GJ) will be started in supine posture for 20 min and VO2 measured again in duplicate. The subject will be asked to sit in a chair for 20 min and VO2 will be measured in duplicate. Gentle Jogger (GJ) will be started in seated posture for 20 min and VO2 measured again in duplicate. Receives: Device: Gentle Jogger (GJ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Rest in Oxygen Consumption
oxygen consumption measured by indirect calorimetry
Measured: After 20 min of Rest and after 20 min of Gentle Jogger
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jun 2018
- 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 (1)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Non randomized, single group study comparing the effects of GJ on resting oxygen consumption (VO2) measurements in seated and supine postures
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sackner Wellness Products LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marvin Sackner, MD, Study director, CEO Sackner WellnessJose A Adams, MD, Principal investigator, Director of Research Sackner Wellness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602365
- Sponsor's protocol ID
- GJHP2017COMP
- Status last verified
- Sep 2019
- First submitted
- 18 Jul 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sackner MA, Lopez JR, Banderas V, Adams JA. Can Physical Activity While Sedentary Produce Health Benefits? A Single-Arm Randomized Trial. Sports Med Open. 2020 Oct 2;6(1):47. doi: 10.1186/s40798-020-00278-3.
PubMed 33006749
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
- Effects of Gentle Jogger on Oxygen Consumption
- ClinicalTrials.gov ID
- NCT03602365
- Acronym / sponsor ID
- GJHP2017COMP
- Conditions
- Physical Inactivity, Oxygen Consumption
- Keywords
- Oxygen Consumption, Physical Activity, Passive Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sackner Wellness Products LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 26 Jul 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.
This is a non randomized study to determine the effects of Gentle Jogger(GJ), a passive jogging device on oxygen consumption in 2 postures supine and seated. Oxygen consumption measurements will be performed via indirect calorimetry in duplicate at rest ( supine and seated posture) , and repeated in duplicate during GJ (in supine and seated posture)
Detailed description
The Gentle Jogger (GJ) is a patented non-FDA regulated wellness device in which GJ; 1) as part of a healthy lifestyle may help 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 heart disease, high blood pressure and type 2 diabetes. GJ is a passive simulated jogging device which moves the feet up and down passively, simulating jogging. GJ addresses the major health problem of physical inactivity.
This is a non randomized study of adult subjects on the effects of Gentle Jogger (GJ) on resting oxygen consumption (VO2).
This study will determine whether or not the use of GJ in either sitting or supine postures changes resting oxygen consumption, measured using indirect calorimetry method.
Potential study subjects will be invited to participate, and informed consent obtained from each subject.
Each subject will me asked to lie in supine posture for 20 mins followed by duplicate measurements of VO2. The GJ will be started in supine posture for 20 min followed by duplicate measurements of VO2. The subject will then be asked to sit in a chair for 20 min, followed by duplicate measurement of VO2, The GJ will be started for 20 min in seated posture followed by duplicate measurements of VO2.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non randomized, single group study comparing the effects of GJ on resting oxygen consumption (VO2) measurements in seated and supine postures
| Arm | Type | Receives |
|---|---|---|
| OXYGEN CONSUMPTION SINGLE ARM | Experimental | Device: Gentle Jogger (GJ)Single arm Study Volunteer will h lie in supine posture for 20 min and oxygen consumption(VO2) will be measured in duplicate. Gentle Jogger (GJ) will be started in supine posture for 20 min and VO2 measured again in duplicate. The subject will be asked to sit in a chair for 20 min and VO2 will be measured in duplicate. Gentle Jogger (GJ) will be started in seated posture for 20 min and VO2 measured again in duplicate. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult subjects > 25 yrs old
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Inability to follow command
- Physically unable to move feet up and down on a gentle jogger
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 Jogger (GJ)Gentle jogger is a passive jogging device which passively moves the feet up and down simulating jogging | Device | OXYGEN CONSUMPTION SINGLE ARM |
Primary outcome
Change from Rest in Oxygen Consumption
Time frame: After 20 min of Rest and after 20 min of Gentle Jogger
oxygen consumption measured by indirect calorimetry
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 33006749Sackner MA, Lopez JR, Banderas V, Adams JA. Can Physical Activity While Sedentary Produce Health Benefits? A Single-Arm Randomized Trial. Sports Med Open. 2020 Oct 2;6(1):47. doi: 10.1186/s40798-020-00278-3.
- Individual participant dataSharing planned: No
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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.
Marvin Sackner, MD study director
CEO Sackner Wellness
Jose A Adams, MD principal investigator
Director of Research Sackner Wellness
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 (GJ) in people with Physical Inactivity and Oxygen Consumption, 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 1 inclusion and 3 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. 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?
Change from Rest in Oxygen Consumption (time frame: After 20 min of Rest and after 20 min of Gentle Jogger). 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 NCT03602365, which also lists 1 linked publication.
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.