NCT03602365

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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1.5 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

September 1, 2019

Enrollment Period

1.6 years

First QC Date

July 18, 2018

Last Update Submit

January 23, 2020

Conditions

Keywords

Oxygen ConsumptionPhysical ActivityPassive Motion

Outcome Measures

Primary Outcomes (1)

  • Change from Rest in Oxygen Consumption

    oxygen consumption measured by indirect calorimetry

    After 20 min of Rest and after 20 min of Gentle Jogger

Study Arms (1)

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.

Device: Gentle Jogger (GJ)

Interventions

Gentle jogger is a passive jogging device which passively moves the feet up and down simulating jogging

OXYGEN CONSUMPTION SINGLE ARM

Eligibility Criteria

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

You may qualify if:

  • Adult subjects \> 25 yrs old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Marvin Sackner, MD

    CEO Sackner Wellness

    STUDY DIRECTOR
  • Jose A Adams, MD

    Director of Research Sackner Wellness

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Non randomized, single group study comparing the effects of GJ on resting oxygen consumption (VO2) measurements in seated and supine postures
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2018

First Posted

July 26, 2018

Study Start

June 1, 2018

Primary Completion

January 23, 2020

Study Completion

January 23, 2020

Last Updated

January 27, 2020

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations