Effects of Simulated Passive Jogging Device on Glucose Homeostasis, Muscle Strength and Endurance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-05

Study Completion Date

2020-01-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gentle Jogger and Oxygen Consumption

NCT03602365

Physical Inactivity Oxygen Consumption

COMPLETED NA

The Effects of Altering Physical Activity on Cardiometabolic Health

NCT01879059

Insulin Resistance

COMPLETED NA

The Effectiveness of Resistance Training on Glycemic Control for Patients With Type 2 Diabetes in Cardiac Rehabilitation

NCT02707380

Type 2 Diabetes (T2DM) Cardiovascular Disease

COMPLETED NA

Exercise as a Tool for Studying the Mechanisms and Applicability of Glycemic Variability

NCT02262208

Type 2 Diabetes

UNKNOWN NA

Effects of Progressive Intensity Exercise Training on Glycemic Control in Older Adults

NCT03154073

PreDiabetes Aging

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Glucose Metabolism Disorders Physical Activity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GJ-Only

Study Subjects with Baseline Glucose of \> 150mg/dl, will have Gentle Jogger Only for 7 days

Group Type EXPERIMENTAL

Gentle Jogger

Intervention Type DEVICE

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

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

Group Type EXPERIMENTAL

Gentle Jogger

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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