Clinical trial NCT03602365: Gentle Jogger and Oxygen Consumption
Official title: Effects of Gentle Jogger on Oxygen Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Oxygen Consumption
Keywords: Oxygen Consumption
Physical Activity
Passive Motion
Lead sponsor: Sackner Wellness Products LLC
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non randomized, single group study comparing the effects of GJ on resting oxygen consumption (VO2) measurements in seated and supine postures
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Adult subjects \> 25 yrs old

Exclusion Criteria:

* Unable to provide informed consent
* Inability to follow command
* Physically unable to move feet up and down on a gentle jogger

Primary outcomes:
measure: Change from Rest in Oxygen Consumption
timeFrame: After 20 min of Rest and after 20 min of Gentle Jogger
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: CIC Miami
state: Florida
Study officials:
affiliation: CEO Sackner Wellness
name: Marvin Sackner, MD
role: STUDY_DIRECTOR
affiliation: Director of Research Sackner Wellness
name: Jose A Adams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.