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Trial record 1 of 1 for:    NCT03550105
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Effects of Simulated Passive Jogging Device on Glucose Homeostasis, Muscle Strength and Endurance

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ClinicalTrials.gov Identifier: NCT03550105
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Sackner Wellness Products LLC

Brief Summary:
Physical Inactivity and excessive sedentary behavior are risk factors for diabetes and cardiovascular disease. Movement is important for overall health. This study will assess the validity and usefulness of low risk, non-invasive wellness device, the Gentle Jogger® (GJ) that passively simulates the physical activities of jogging. The study will evaluate whether or not use of GJ modifies glycemic control and muscle strength in subjects who are known to be diabetic and those who are not. The study volunteers are subjects between the ages of 25-80yr.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Glucose Metabolism Disorders Physical Activity Device: Gentle Jogger Not Applicable

Detailed Description:

Excessive sedentary behavior and physical inactivity are independent risk factors for; obesity, metabolic syndrome, heart disease, Type 2 Diabetes Mellitus (T2DM), and hypertension. In adults with T2DMT interrupting prolonged sitting improves glycemic control. Increasing physical activity even briefly (3-15 min) is effective in reducing postprandial hyperglycemia and improving glycemic control. To address the excessive sedentary behavior Sackner Wellness Products has patented a non-invasive method for inducing passive movement while in seated or supine posture the Gentle Jogger® (GJ)which simulates the activities of jogging. Passive simulation of jogging introduces pulses into the circulation as the foot strikes the device. These pulsations have been shown to elicit production of beneficial mediators which are important to cardiovascular health. The study will recruit two groups of subjects ages 25-80. One group (n=45) of either sex who are not known to be diabetics and have a normal fasting glucose. Another group (n=45) who are known to be diabetics (Type 1 or Type 2) previously diagnosed by their physician and currently on insulin and or oral medications. Exclusion criteria are those younger than 25yrs and greater than 80yrs, and inability to provide informed consent. The study will last 14 days total and will consist of 5 study visit days. Volunteers will be paid for their participation in the study.

On day 1 participants will have a continuous interstitial glucose sensor ( Freestyle Libre Pro), and an activity monitor placed. The participants will have their blood pressure measured and muscle strength and endurance measured using a dynamometer which measures grip force. Based on the average glucose obtained on day 1-2 of the study, subjects will be assigned to two groups. A) GJ-Only (subjects with baseline average glucose of > 150mg/dl or B) GJ with Oral Glucose Tolerance Testing(GJ-OGTT) (subjects with baseline average glucose of < 150mg/dl).

On day 3 those enrolled in GJ-OGTT groups will have a basal oral glucose tolerance test and grip force and blood pressure will be measure before and after the OGTT. Those enrolled in GJ -Only group will only have grip force and blood pressure measured. Day 4 of the study all subjects will be instructed on the use of GJ device and will be asked to use the device 3 times per day for 30 min, from day 4 till day 11. On day 11 those enrolled in GJ-OGTT groups will have a repeat oral glucose tolerance test , grip force and blood pressure will be measure before and after the OGTT. Those enrolled in GJ -Only group will only have grip force and blood pressure measured. On day 14 all subjects will have grip force and blood pressure measured and a brief debriefing about their experience with GJ.

The total days enrolled in the study are14 days.

The Gentle Jogger's intended use as a wellness device in which , 1) GJogger are part of a healthy lifestyle, which may help to reduce the risk of 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A) Study Subjects with Baseline Glucose of > 150mg/dl, will have Gentle Jogger Only for 7 days B) Study Subjects with Baseline Glucose of < 150 mg/dl will have basal oral glucose tolerance test (OGTT) and repeat OGTT after 7 days of Gentle Jogger
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Simulated Passive Jogging Device on Glucose Homeostasis, Muscle Strength and Endurance
Actual Study Start Date : June 5, 2018
Actual Primary Completion Date : January 23, 2020
Actual Study Completion Date : January 23, 2020

Arm Intervention/treatment
Experimental: GJ-Only
Study Subjects with Baseline Glucose of > 150mg/dl, will have Gentle Jogger Only for 7 days
Device: Gentle Jogger
Gentle Jogger is a passive simulated jogging device to be used 3 times per day for at least 30 mins for 7 days in this study

Experimental: GJ-OGTT
Study Subjects with Baseline Glucose of < 150mg/dl, will have Oral Glucose Tolerance Test (OGTT) at baseline and after 7 days of Gentle Jogger
Device: Gentle Jogger
Gentle Jogger is a passive simulated jogging device to be used 3 times per day for at least 30 mins for 7 days in this study




Primary Outcome Measures :
  1. Glycemic Control [ Time Frame: 8 days ]
    For GJ-OGTT Group: Blunting of the peak and decrease of the area under the curve of the Oral Glucose Tolerance after 7 days of Gentle Jogger For GJ-Only Blunting or decreased of basal glucose levels ( 3 days prior to GJ) compared to glucose levels after 7 days of GJ


Secondary Outcome Measures :
  1. Variability of Glycemic Control - (24 hrs Standard Deviation of Glycemia) [ Time Frame: 8 Days ]
    Comparison of 24 hrs of Glycemic variability at 3 time periods a)24 hrs before GJ b) the last 24 hrs of GJ and c) Last 24 hrs of study ( day 13-14)

  2. Muscle Strength [ Time Frame: 8 days ]
    For GJ-OGTT Group: improved grip force after 7 days of GJ Compared to prior to GJ For GJ-Only improved grip force after 7 days of GJ Compared to prior to GJ

  3. Muscle Endurance [ Time Frame: 8 days ]
    For GJ-OGTT Group: improved grip endurance after 7 days of GJ Compared to prior to GJ For GJ-Only improved grip force and endurance after 7 days of GJ Compared to prior to GJ

  4. Carry Over Effect of Muscle Strength [ Time Frame: 14 days ]
    For BOTH Groups: Comparison of grip force between last day of GJ and day 14 ( 3 days after completion of GJ)

  5. Carry Over Effect of Muscle Endurance [ Time Frame: 14 days ]
    For BOTH Groups: Comparison of muscle strength between last day of GJ and day 14 ( 3 days after completion of GJ)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers able to consent ages 25-80yrs
  • Known Diabetics (Type 1 or Type 2)- Previously diagnosed by their physician on either Insulin and or oral diabetic medications ages 25-80yrs

Exclusion Criteria:

  • Younger than 25 yrs or Older than 80 yrs
  • Unable to provide consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550105


Locations
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United States, Florida
CIC Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
Sackner Wellness Products LLC

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Responsible Party: Sackner Wellness Products LLC
ClinicalTrials.gov Identifier: NCT03550105    
Other Study ID Numbers: GJHP03122018
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sackner Wellness Products LLC:
Glucose
Diabetes
Physical Activity
Passive Exercise
Blood Pressure
Muscle Strength
Muscle Endurance
Hypertension
Physical Inactivity
Additional relevant MeSH terms:
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Metabolic Diseases
Glucose Metabolism Disorders