A Nonrandomized Trial of the Effects of Passive Simulated Jogging on Short-Term Heart Rate Variability in Type 2 Diabetic Subjects.

Background: Diabetes mellitus has reached global epidemic proportions, with type 2 diabetes (T2DM) comprising more than 90% of all subjects with diabetes. Cardiovascular autonomic neuropathy (CAN) frequently occurs in T2DM. Heart rate variability (HRV) reflects a neural balance between the sympathetic and parasympathetic autonomic nervous systems (ANS) and a marker of CAN. Reduced HRV has been shown in T2DM and improved by physical activity and exercise. External addition of pulses to the circulation, as accomplished by a passive simulated jogging device (JD), restores HRV in nondiseased sedentary subjects after a single session. We hypothesized that application of JD for a longer period (7 days) might improve HRV in T2DM participants. Methods: We performed a nonrandomized study on ten T2DM subjects (age range 44-73 yrs) who were recruited and asked to use a physical activity intervention, a passive simulated jogging device (JD) for 7 days. JD moves the feet in a repetitive and alternating manner; the upward movement of the pedal is followed by a downward movement of the forefoot tapping against a semirigid bumper to simulate the tapping of feet against the ground during jogging. Heart rate variability (HRV) analysis was performed using an electrocardiogram in each subject in seated posture on day 1 (baseline, BL), after seven days of JD (JD7), and seven days after discontinuation of JD (Post-JD). Time domain variables were computed, viz., standard deviation of all normal RR intervals (SDNN), standard deviation of the delta of all RR intervals (SDΔNN), and the square root of the mean of the sum of the squares of differences between adjacent RR intervals (RMSSD). Frequency domain measures were determined using a standard Fast Fourier spectral analysis, as well as the parameters of the Poincaré plots (SD1 and SD2). Results: Seven days of JD significantly increased SDNN, SDΔNN, RMSSD, and both SD1 and SD2 from baseline values. The latter parameters remained increased Post-JD. JD did not modify the frequency domain measures of HRV. Conclusion: A passive simulated jogging device increased the time domain and Poincaré variables of HRV in T2DM. This intervention provided effortless physical activity as a novel method to harness the beneficial effects of passive physical activity for improving HRV in T2DM subjects.

The Effects of Passive Simulated Jogging on Parameters of Explosive Handgrip in Nondiabetics and Type 2 Diabetics: A Single Arm Study.

AIMS: Type 2 diabetes (T2D) is associated with sarcopenia and decreased muscle strength. Explosive and isometric voluntary handgrip strengths (EHGS and HGS) are frequently utilized methods to ascertain health status and a marker of overall muscle strength. We have previously shown that a portable, motorized device, which produces effortless, rapid stepping in place (passive simulated jogging device (JD)), improves glucose homeostasis. This study quantitatively evaluated the effects of JD in modifying parameters of the modified EHGS curve in T2D and nondiabetic (ND) subjects. METHODS: Twenty-one adult participants (11 ND and 10 T2D) (mean age: 41.3 ± 13.5 yr) performed a modified explosive handgrip strength (EHGS) test on study day 1 followed by daily use of JD (90 min per day) for 7 days. The EHGS was repeated after 3 and 7 days' use of JD (JD3 and JD7) and 3 days after completion of JD (Carryover). EHGS curves were analyzed for the following: maximal peak force value (MAX); rate of force development at 25%,75%, and 90% of maximum force; and maximum force (RFD25%, RFD75%, RFD90%, and RFDmax); time to 90%, 75%, and 25% of maximal force (t 90, t 75, t 25) and time to maximal force (t max); and the integrated area under the curve for force vs. time until task failure (iAUCTF); and fatigue resistance times at 50% and 25% of maximal force (FR50 and FR25) and fatigue resistance time to task failure (FRTF). RESULTS: At baseline, T2D had lower MAX compared to ND. There were no differences at baseline for force development time or fatigue resistance time between T2D and ND. In both T2D and ND, 7 days of JD increased FR25 and FRTF and iAUCTF compared to baseline. CONCLUSION: JD for at least 7 days prior to EHGS increased time to task failure (fatigue resistance) and iAUCTF of the force-time curve. JD is a reasonable intervention to decrease sedentary behavior and improve muscle fatigue resistance under various clinical and nonclinical scenarios. This trial is registered with NCT03550105 (08-06-2018).

A single arm trial using passive simulated jogging for blunting acute hyperglycemia.

Glycemic fluctuations increase oxidative stress, promote endothelial dysfunction and cardiovascular disease. Reducing glycemic fluctuations is beneficial. We previously reported that a portable motorized passive simulated jogging device, (JD) reduces 24 h glycemic indices in type 2 and non-diabetic subjects. This study evaluates effectiveness and feasibility of JD in blunting large glycemic fluctuation induced by an oral glucose tolerance test (OGTT). The study was performed in 10 adult participants mean age 41.3 ± 13.5 year using interstitial glucose monitor (IG). Each participant fasted for 8 h. followed by an OGTT (Pre-JD), thereafter JD was used for 90 min per day for 7 days, without change to diet or activities of daily living. A repeat OGTT (Post-JD) was performed after completion. The integrated area under the curve (iAUC2h-4h) was computed for the OGTT Pre-JD and Post-JD. Seven days of JD blunted the glucose fluctuation produced by OGTT. JD decreased AUC2h by 17 ± 4.7% and iAUC4h by 15 ± 5.9% (p < 0.03). In healthy mostly obese participants 7 days of JD blunts the hyperglycemic response produced by an OGTT. JD may be an adjunct to current glycemic management, it can be applied in different postures for those who cannot (due to physical or cognitive limitations) or will not exercise.Trial registration: ClinicalTrials.gov NCT03550105 (08-06-2018).

Can Physical Activity While Sedentary Produce Health Benefits? A Single-Arm Randomized Trial.

BACKGROUND: Sedentary time poses a risk to health. Substituting physical activity for inactivity is obvious but this requires a behavior change. Interventions advocated to decrease uninterrupted physical inactivity (defined as Metabolic Equivalent of Task (METS) less than 1.5) are important. One such intervention is accomplished with the Gentle Jogger (GJ), a low risk motorized wellness device which produces effortless, rapid motion of the lower extremities simulating locomotion or fidgeting. GJ produces health benefits in type 2 diabetes, heart disease, and high blood pressure. The purpose of this trial was to ascertain whether GJ increases METS above 1.5 to explain its effectiveness despite sedentary behavior or whether tapping is responsible. METHODS: A randomized single-arm trial was conducted. Subjects were randomized to begin the study in either the supine or seated postures and on the same day crossed over with the starting posture reversed. Oxygen consumption was measured at rest and during GJ. RESULTS: Twenty-six subjects were studied (15 women and 11 men) with a mean age of 44 ± 15 years and BMI 27.9 ± 5.0, 19 were overweight or obese, and 7 had normal BMI. GJ increased oxygen consumption and METS 15% in the seated posture and 13% in the supine posture. No individual receiving GJ achieved METS exceeding 1.5. CONCLUSIONS: In a moderately obese population, GJ in seated or supine posture did not exceed 1.5 METS. The values are comparable to those reported for sit-stand interventions and cannot explain the health benefits of GJ. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03602365 . Registered on July 26, 2018.

Portable Gentle Jogger Improves Glycemic Indices in Type 2 Diabetic and Healthy Subjects Living at Home: A Pilot Study.

BACKGROUND: Physical inactivity is a high-risk factor for type 2 diabetes. Increased physical activity improves indices of glycemic control. Continuous glucose monitoring (CGM) allows the investigation of glycemic control during activities of daily living. A pilot study was undertaken to determine the effects of the portable Gentle Jogger (passive simulated jogging device (JD)) that decreases physical inactivity by effortlessly producing body movements on glycemic indices of healthy and type 2 diabetes subjects using CGM during activities of daily living. METHODS: A single-arm, nonblinded study was carried out in 22 volunteers (11 type 2 diabetics and 11 healthy subjects), using continuous glucose monitoring (CGM) for 14 days. On day 4, subjects were provided with JD and instructed to use it a minimum of 3 times per day for 30 min for 7 days. CGM data was analyzed at baseline (BL) and during 2, 3, 4, 5, 6, and 7 days of JD (JD 2, 3, 4, 5, 6, 7) and 1-2-day post JD (Post JD1 and 2) and the following 24 hr indices computed mean glucose (mGLu), SUM of all glucose values, % coefficient of variation (%CV), area under the 24-hour curve (AUC), time spent above range (TAR, glucose 180-250 mg/dl), and time in range (TIR). RESULTS: In healthy subjects, there were significantly lower values of mGlu and SUM compared to BL for all days of JD usage. In type 2 diabetics, mGlu, SUM, and AUC were significantly lower compared to BL, for all days of JD usage and Post JD1. TAR was significantly lower and TIR significantly improved during JD, in type 2 diabetics without change in %CV. CONCLUSION: Gentle Jogger is a portable, passive movement technology that reduces physical inactivity while improving 24 hr glycemic control. It can be self-administered as a standalone device or as an adjunct to diabetic medications. This trial is registered with NCT03550105.

Holistic approach to opioid use disorder: Think nitric oxide!

This review deals with opioid addiction, chronic pain, and an innovative, noninvasive technology with simultaneous, beneficial applications for both conditions. This technology, called passive simulated jogging device (GENTLE JOGGER, JD) targets addiction and pain by increasing endothelial nitric oxide (NO) bioavailability. It can be self-administered while sitting or lying without resorting to multitasking thereby allowing watching television or operating a computer while effortless, physical activity is produced from motorized foot pedals repetitively striking a bumper at 175-190 times per minute which adds small pulses to the circulation. This action increases shear stress (friction) to vascular endothelium that stimulates endothelial nitric oxide synthase (eNOS) to increase NO that decreases oxidative stress and inflammation, and, slows accelerated vascular ageing associated with opioids. Since the 1970s, clonidine, lofexidine, and dexmedetomidine have been used offlabel to suppress opioid withdrawal symptoms precipitated by excessive release of norepinephrine. These pharmacotherapy aids to withdrawal and tapering opioid dosagadrenoceptor agonists that act through eNOS to inhibit norepinephrine. Increasing NO as with JD and/ or in conjunction with opioid agonists should help stabilization, tapering, withdrawal, and relapses stages of addiction. Nitric oxide as increased with JD technology is antinociceptive as demonstrated in chronic and subacute pain states, viz., fibromyalgia, osteoarthritis, peripheral arterial disease, delayed onset of muscle soreness (DOMS), and sickle cell disease. Jogging device decreases elevated blood pressure that is produced with physical inactivity, a risk to opioid use disorder (OUD). Thus, JD provides holistic, cost-effective approach to opioid addiction as well as chronic and subacute pain.