Frequency-tuned electromagnetic field therapy improves post-stroke motor function: A pilot randomized controlled trial.

Background and purpose: Impaired upper extremity (UE) motor function is a common disability after ischemic stroke. Exposure to extremely low frequency and low intensity electromagnetic fields (ELF-EMF) in a frequency-specific manner (Electromagnetic Network Targeting Field therapy; ENTF therapy) is a non-invasive method available to a wide range of patients that may enhance neuroplasticity, potentially facilitating motor recovery. This study seeks to quantify the benefit of the ENTF therapy on UE motor function in a subacute ischemic stroke population. Methods: In a randomized, sham-controlled, double-blind trial, ischemic stroke patients in the subacute phase with moderately to severely impaired UE function were randomly allocated to active or sham treatment with a novel, non-invasive, brain computer interface-based, extremely low frequency and low intensity ENTF therapy (1-100 Hz, < 1 G). Participants received 40 min of active ENTF or sham treatment 5 days/week for 8 weeks; ~three out of the five treatments were accompanied by 10 min of concurrent physical/occupational therapy. Primary efficacy outcome was improvement on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE) from baseline to end of treatment (8 weeks). Results: In the per protocol set (13 ENTF and 8 sham participants), mean age was 54.7 years (±15.0), 19% were female, baseline FMA-UE score was 23.7 (±11.0), and median time from stroke onset to first stimulation was 11 days (interquartile range (IQR) 8-15). Greater improvement on the FMA-UE from baseline to week 4 was seen with ENTF compared to sham stimulation, 23.2 ± 14.1 vs. 9.6 ± 9.0, p = 0.007; baseline to week 8 improvement was 31.5 ± 10.7 vs. 23.1 ± 14.1. Similar favorable effects at week 8 were observed for other UE and global disability assessments, including the Action Research Arm Test (Pinch, 13.4 ± 5.6 vs. 5.3 ± 6.5, p = 0.008), Box and Blocks Test (affected hand, 22.5 ± 12.4 vs. 8.5 ± 8.6, p < 0.0001), and modified Rankin Scale (-2.5 ± 0.7 vs. -1.3 ± 0.7, p = 0.0005). No treatment-related adverse events were reported. Conclusions: ENTF stimulation in subacute ischemic stroke patients was associated with improved UE motor function and reduced overall disability, and results support its safe use in the indicated population. These results should be confirmed in larger multicenter studies. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT04039178, identifier: NCT04039178.

Occupational stress and hypertension.

Occupational stress, or job strain, resulting from a lack of balance between job demands and job control, is considered one of the frequent factors in the etiology of hypertension in modern society. Stress, with its multifactorial causes, is complex and difficult to analyze at the physiological and psychosocial levels. The possible relation between job strain and blood pressure levels has been extensively studied, but the literature is replete with conflicting results regarding the relationship between the two. Further analysis of this relationship, including the many facets of job strain, may lead to operative proposals at the individual and public health levels designed to reduce the effects on health and well-being. In this article, we review the literature on the subject, discussing the various methodologies, confounding variables, and suggested approaches for a healthier work environment.

Effect of non-drug interventions on arterial properties determined from 24-h ambulatory blood pressure measurements.

Measures derived from the slope of the linear relationship between systolic and diastolic pressures obtained by 24-h ambulatory blood pressure (ABP) measurements incorporate clinical and prognostic information, and are believed to be vascular markers. Using post hoc analysis, we investigated potential changes of these 'slope-related measures' in three different studies conducted in hypertensive patients with before and after 24-h ABP measurements, and also evaluated the sensitivity of the results to the analysis method. Two interventional studies included 8-week device-guided breathing (DGB) exercised by 13 patients with uncontrolled blood pressure (BP), and a 6-month mineral potassium chloride-enriched diet administered to 20 elderly patients. One study was observational and involved winter-to-summer change experienced by 13 patients with controlled BP. Slope-related measures included systolic-on-diastolic slope and its equivalent 1-(diastolic-on-systolic slope) called Ambulatory Arterial Stiffness Index, and were determined using three different BP-averaging methods and two types of regression procedures. Results demonstrated sensitivity of slope-related measures to the analysis method, the most significant changes were found when the before and after 24-h ABP profiles included hourly averaged BP further averaged over the patient population, and slope-related measures were determined using symmetric (and not standard) regression. DGB was found to reduce significantly all these measures. The changes in the slope-related variables for individual patients correlated negatively with its baseline value and positively with the observed pulse pressure changes. In conclusion, the study provides evidence that DGB can affect positively vascular markers associated with cardiovascular risk, and suggests improved analysis methods for the determination of slope-related measures in interventional studies.

Combating Combination of Hypertension and Diabetes in Different Rat Models.

Rat experimental models are used extensively for studying physiological mechanisms and treatments of hypertension and diabetes co-existence. Each one of these conditions is a major risk factor for cardiovascular disease (CVD), and the combination of the two conditions is a potent enhancer of CVD. Five major animal models that advanced our understanding of the mechanisms and therapeutic approaches in humans are discussed in this review: Zucker, Goto-Kakizaki, SHROB, SHR/NDmcr-cp and Cohen Rosenthal diabetic hypertensive (CRDH) rats. The use of various drugs, such as angiotensin-converting enzyme (ACE) inhibitors (ACEIs), various angiotensin receptor blockers (ARBs), and calcium channel blockers (CCBs), to combat the effects of concomitant pathologies on the combination of diabetes and hypertension, as well as the non-pharmacological approach are reviewed in detail for each rat model. Results from experiments on these models indicate that classical factors contributing to the pathology of hypertension and diabetes combination-Including hypertension, hyperglycemia, hyperinsulinemia and hyperlipidemia-can now be treated, although these treatments do not completely prevent renal complications. Animal studies have focused on several mechanisms involved in hypertension/diabetes that remain to be translated into clinical medicine, including hypoxia, oxidative stress, and advanced glycation. Several target molecules have been identified that need to be incorporated into a treatment modality. The challenge continues to be the identification and interpretation of the clinical evidence from the animal models and their application to human treatment.

Device-guided paced breathing in the home setting: effects on exercise capacity, pulmonary and ventricular function in patients with chronic heart failure: a pilot study.

BACKGROUND: Regular slow breathing is known to improve autonomic cardiac regulation and reduce chemoreflex sensitivity in heart failure. We explored the acceptability and usefulness of a device for paced slow breathing at the home setting. METHODS AND RESULTS: In this open pilot study, 24 patients with chronic heart failure (61% males, mean age, 64+/-9 years; New York Heart Association class, 2.81+/-0.01) were randomized to a control group receiving conventional treatment (n=12) or to a group receiving conventional treatment and device-guided paced breathing (n=12). Groups were comparable for age, therapies, and clinical characteristics. They were evaluated at baseline and again after 10 weeks by Doppler echocardiography, pulmonary function, cardiopulmonary stress test, and quality of life (Minnesota Quality of Life questionnaire). The treatment group was instructed to use the equipment for 18 minutes twice daily. The device is a computerized box connected to a belt-type respiration sensor and to headphones; it generates musical tones (based on the user's breathing rate and inspiration ratio), which guide the user to progressively and effortlessly slow his or her breathing rate <10 breaths/min. The treatment group showed high compliance to the device (90% of the prescribed sessions were completed). Blinded analysis of data demonstrated increased ejection fraction and decreased estimated pulmonary pressure in the echocardiograms of the treated group versus controls and favorable changes in New York Heart Association class, Ve/Vco(2), FEV(1), and a quality of life measure, as well (all P<0.05). CONCLUSIONS: This pilot investigation demonstrates that device-guided paced breathing at home is feasible and results in an improvement in clinically relevant parameters for patients with heart failure and systolic dysfunction.

Graded blood pressure reduction in hypertensive outpatients associated with use of a device to assist with slow breathing.

To study the effects of device-guided breathing on office systolic blood pressure (SBP), five centers randomized 149 untrained hypertensives (50% male, age 59+/-10 years, baseline blood pressure 150+/-9/86+/-9 mm Hg, 77% taking drug therapy). One half received a device to guide slow breathing; all received a home blood pressure monitor and only simple, written instructions. The changes in office SBP (adjusted for office-to-home difference in baseline SBP and accumulated time spent in slow breathing, guided and measured by the device) were significantly (p<0.001 for trend) correlated with accumulated time spent in slow breathing. Greater decreases in SBP (-15.0+/-1.8 vs. -7.3+/-1.9 mm Hg) were observed for those who spent more (vs. less) than 180 minutes over 8 weeks in slow breathing, as well as those who just monitored their blood pressure at home (-9.2+/-1.6 mm Hg). Thus, even without training, hypertensive patients who receive a device to guide slow breathing significantly lowered their office SBP if the total time spent in slow breathing over 8 weeks exceeded a "threshold" value of 180 minutes.

Nonpharmacologic treatment of resistant hypertensives by device-guided slow breathing exercises.

BACKGROUND: Recent studies have demonstrated the antihypertensive effect of slow breathing exercises, guided interactively by a device, in patients with uncontrolled blood pressure (BP) without changing medication. This study examined the response to the same treatment protocol in resistant hypertensives. METHODS: Seventeen resistant hypertensives exercised device-guided slow breathing for 8 weeks, 15 min daily, and self-monitored BP. Data stored in the devices were collected on a PC-based system. Clinical outcomes were office and home BP changes from baseline to end values. RESULTS: Significant reductions in both office BP (-12.9/-6.9 mm Hg, P <.001 and home BP (-6.4/-2.6 mm Hg, P <.01/P <.05) without side effects with 82% responders and good compliance. CONCLUSIONS: Resistant hypertensives can benefit from and are compliant with self-treatment by device-guided slow breathing.