Comparison of Outcomes with Midodrine and Fludrocortisone for Objective Recurrence in Treating Syncope (COMFORTS trial): Rationale and design for a multi-center randomized controlled trial.

BACKGROUND: The cornerstone of the treatment of vasovagal syncope (VVS) is lifestyle modifications; however, some patients incur life-disturbing attacks despite compliance with these treatments which underscores the importance of pharmacological interventions. METHODS: In this open-label multi-center randomized controlled trial, we are going to randomize 1375 patients with VVS who had ≥2 syncopal episodes in the last year into three parallel arms with a 2:2:1 ratio to receive midodrine, fludrocortisone, or no medication. All patients will be recommended to drink 2 to 3 liters of fluids per day, consume 10 grams of NaCl per day, and practice counter-pressure maneuvers. In medication arms, patients will start on 5 mg of midodrine TDS or 0.05 mg of fludrocortisone BD. After one week the dosage will be up-titrated to midodrine 30 mg/day and fludrocortisone 0.2 mg/day. Patient tolerance will be the principal guide to dosage adjustments. We will follow-up the patients on 3, 6, 9, and 12 months after randomization. The primary outcome is the time to first syncopal episode. Secondary outcomes include the recurrence rate of VVS, time interval between first and second episodes, changes in quality of life (QoL), and major and minor adverse drug reactions. QoL will be examined by the 36-Item Short Form Survey questionnaire at enrollment and 12 months after randomization. CONCLUSION: The COMFORTS trial is the first study that aims to make a head-to-head comparison between midodrine and fludrocortisone, against a background of lifestyle modifications for preventing recurrences of VVS and improving QoL in patients with VVS.

The Effects of Electrical Stimulation of Lower Extremity Muscles on Balance in Stroke Patients: A Systematic Review of Literatures.

OBJECTIVE: Stroke is one of the main causes of disability and the second common cause of mortality in the world. Stroke causes relatively permanent motor defects, including balance disorder, and thus affects an individual's functional capacity and independence. Many clinical types of research have been conducted to evaluate the effect of functional electrical stimulation (FES) on balance in post-stroke patients. The objective of this study was to systematically review the effect of functional electrical stimulation (FES) on balance as compared to conventional therapy alone in post-stroke. METHODS: The databases of Google Scholar, PubMed, Scopus, ScienceDirect and ProQuest were searched using selected keywords. The randomized controlled trials were searched for published original articles before February 2019 in English language and included if they assessed the effect of FES on balance ability compared to conventional therapy alone in adult post-stroke. The Physiotherapy Evidence Database (PEDro) scale was used to assess the methodological quality. RESULTS: Nine papers were included in this review (median PEDro scale =7/11). The total number of participants in this review study was 255. The age of participants ranged from 20 to 80 years. Stroke patients were in chronic phase (n = 5) and in subacute phase (n = 4). various parameters, including the target muscles, the treatment time per session (20 min-2 h), number of treatment sessions (12-48) and FES frequency (25-40 Hz), were assessed. Among the studies, significant between-group improvement favoring FES in combination with conventional therapy was found on the Berg Balance Scale (n = 7) and Timed Up and Go Scale (n = 4) when compared to conventional therapy alone. There was no adverse effect reported by any studies. CONCLUSION: FES was reported to be more beneficial in balance improvement among stroke patients when combined with conventional balance therapy. The studies were limited by low-powered, small sample sizes ranging from 9 to 48, and lack of blinding, and reporting of missing data.

Effects of Virtual Reality Compared to Conventional Therapy on Balance Poststroke: A Systematic Review and Meta-Analysis.

OBJECTIVE: The objective of this study was to systematically review the effect of virtual reality on balance as compared to conventional therapy alone poststroke. METHODS: The databases of PubMed, Cochrane, and Ovid were searched using select keywords. The randomized controlled trials published between January 2000 and August 2017 in English language were included if they assessed the effect of virtual reality on balance ability compared to conventional therapy alone in adults' poststroke. The Physiotherapy Evidence Database scale was used to assess the methodological quality. RESULTS: Fourteen papers were included in this review. The experimental groups largely (n = 13) used virtual reality in combination with conventional therapy. Among the high quality studies, significant between-group improvement favoring virtual reality in combination with conventional therapy was found on Berg Balance Scale (n = 7) and Timed Up and Go Scale (n = 7) when compared to conventional therapy alone. The studies were limited by low powered, small sample sizes ranging from 14 to 40, and lack of blinding, concealed allocation, and reporting of missing data. Thirteen homogenous (n = 348, I2 = 37.6%, P = .083) studies were included in the meta-analysis using Berg Balance Scale. Significant improvement was observed in the experimental group compared to control group with a medium effect size of .64, confidence interval of .36-.92. CONCLUSIONS: The findings of this review indicate that virtual reality when combined with conventional therapy is moderately more effective in improving balance than conventional therapy alone in individuals' poststroke.

Effects of Treadmill Incline and Speed on Ankle Muscle Activity in Subjects After a Stroke.

OBJECTIVES: To examine the effects of walking on a treadmill at varying gradients and speeds on ankle muscle activation in stroke survivors, and to compare the effect of increasing speed on plantarflexor muscle activity in participants grouped according to spasticity severity. DESIGN: Within-subject and cross-sectional design. Participants walked on a standard treadmill at 3 different inclines (0°, 3°, 6°) and speeds (self-selected, self-selected+20%, self selected+40%). SETTING: University laboratory. PARTICIPANTS: A convenience sample of stroke survivors (N=19; 13 men, 6 women) available in university clinics. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Electromyographic activity of medial gastrocnemius (MG) and tibialis anterior (TA) muscles at push-off phase of the gait. RESULTS: Paretic MG muscle activity increased (but TA did not change) at faster speeds irrespective of the incline (P<.05). In contrast, MG muscle activity increased at a higher incline in the nonparetic side (P<.05), but not in the paretic side (P>.05). In the high-spasticity subgroup (Tardieu Scale ≥ 2), paretic MG activity increased as walking speed increased (P=.004). CONCLUSIONS: Stroke survivors appear to use distinct muscle activation strategies on the paretic and nonparetic sides in response to different walking speeds and inclines. Our data indicates that individuals with stroke can be safely trained on a treadmill to walk 20% to 40% above the self-selected pace to improve MG output without adversely affecting TA output. The speed-dependent characteristic of spasticity may help generate greater MG activity during push-off.

Evaluation of the separate and combined effects of anodal tDCS over the M1 and F3 regions on pain relief in patients with type-2 diabetes suffering from neuropathic pain.

BACKGROUND: Neuropathic pain (NP) is a common complication of chronic diabetes that negatively affects the routine functioning and sleep of patients. The present study aimed to investigate the separate and combined effects of anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) and left dorsolateral prefrontal cortex (F3) regions on pain relief in patients with type-2 diabetes suffering from NP. METHODS: The statistical population of this double-blind randomized clinical trial consisted of all the members of the Bonab Diabetes Association in 2022 aged 45 to 65 years who were diagnosed with NP by a specialist. A total of 48 patients who met the inclusion criteria were selected as the sample through purposive sampling. The participants were then randomly assigned into 4 groups, each attending 12 sessions of a special intervention (three times a week). The Short Form-McGill Pain Questionnaire-2 (SF-MPQ-2) was used for data collection. Data were statistically analyzed using SPANOVA, analysis of covariance, and the Bonferroni test. RESULTS: The results showed that tDCS had the potential to induce pain relief in patients with type-2 diabetes suffering from NP (F = 11.48, P < 0.001). The mean perceived pain intensity in the posttest was lower in the M1 stimulation group than in the F3 stimulation group. Nevertheless, there was no significant difference between the two groups in terms of perceived pain intensity in the one-month and two-month follow-up stages. CONCLUSIONS: The tDCS approach (over both M1 and F3) showed promising effects for pain management in patients with type-2 diabetes suffering from NP and may be an effective add-on treatment. However, more trials with larger sample sizes are necessary to define clinically relevant effects.

Synthesis, characterization, and electrochemical evaluation of SnFe2O4@MWCNTS nanocomposite as a potential hydrogen storage material.

The widespread use of hydrogen as a vehicle fuel has prompted us to develop a new nanocomposite by immobilizing of tin ferrite nanoparticles (SnFe2O4) on the surface of multi-walled carbon nanotubes (abbreviated as MWCNTS) for the first time. The prepared nanocomposite powder (SnFe2O4@MWCNTS) was investigated utilizing various microscopy and spectroscopy methods, such as FT-IR, XRD, SEM, EDX, and BET techniques. Moreover, the electrochemical property of SnFe2O4@MWCNTS nanocomposite was investigated by cyclic voltammogram (CV) and charge-discharge chronopotentiometry (CHP) techniques. A variety of factors on the hydrogen storage capacity, such as current density, surface area of the copper foam, and the influence of repeated hydrogen adsorption-desorption cycles were assessed. The electrochemical results indicated that the SnFe2O4@MWCNTS has high capability and excellent reversibility compared to SnFe2O4 nanoparticles (NPs) for hydrogen storage. The highest hydrogen discharge capability of SnFe2O4@MWCNTs was achieved ∼ 365 mAh/g during the 1st cycle, and the storage capacity enhanced to ∼ 2350 mAh/g at the end of 20 cycles using a current of 2 mA. Consequently, the SnFe2O4@MWCNTS illustrated great capacity as a prospective active material for hydrogen storage systems.

Effects of mindful breath awareness and muscle relaxation and transcranial electrical stimulation techniques on improving blood pressure status in patients with type 2 diabetes.

OBJECTIVE: The present study aimed to determine the effects of mindful breath awareness & muscle relaxation (MBMR) and transcranial electrical stimulation (tCES) techniques on improving the systolic and diastolic blood pressure status in patients with type 2 diabetes. METHODS: The research method was randomized controlled trial (RCT) using split-plot ANOVA (SPANOVA). Thirty patients were selected through purposive sampling from Bonab County Diabetes Association (Iran) and were randomly divided into three 10-member groups, namely MBMR, tCES, and MBMR+tCES groups. Participants received their group interventions in 10 individual sessions. All patients were evaluated for systolic and diastolic blood pressure at two stages, before and immediately after each session. SPANOVA and Bonferroni pairwise comparison tests were used for data analysis. RESULTS: The results indicated that the MBMR and tCES techniques, alone and in combination, had significant and equal effects on reducing diastolic blood pressure, but the MBMR treatment was more effective in the systolic blood pressure than the tCES. CONCLUSIONS: The MBMR and tCES techniques were effective and safe in treating hypertension in patients with type 2 diabetes.

Short-term Effects of Elastic Therapeutic Taping on Static and Dynamic Balance in Chronic Stroke.

INTRODUCTION: The current pilot study aimed to examine the short-term effects of ankle Elastic Therapeutic Taping (ETT) on static and dynamic balance. METHODS: Twenty-Four individuals with chronic stroke were assigned to an experimental or control group (n=12/group); they both received Conventional Physical Therapy (CT) for 3 weeks, 3 times per week. The experimental group additionally underwent taping to the ankle of the paretic side continuously for 3 weeks. Standardized measures for static and dynamic balance were administered at pre-test and post-test and analyzed using Wilcoxon and Analysis of Covariance (ANCOVA). RESULTS: The experimental group significantly improved on two measures, Biodex anterior-posterior static (P=0.03) and medial-lateral dynamic (P=0.04) balance indices, compared to the controls. Both groups improved within their respective groups for Berg Balance Scale and Functional Reach (P<0.05). Static balance consistently improved across measures with the experimental intervention with large effect sizes. CONCLUSION: Ankle ETT, combined with CT, may be effective in the short-term for improving static and dynamic balance in stroke, compared to CT alone. A future larger randomized trial with longer follow-up is required to establish this method's effectiveness.

Effects of Elastic Therapeutic Taping on Joint Position Sense of the Ankle in Stroke Survivors.

Impairments in ankle joint position sense along with muscle weakness greatly affect the recovery of balance among stroke survivors. Elastic therapeutic taping has been studied in musculoskeletal conditions of the ankle to improve joint position sense and its effects in stroke are not known. The aims of the study were to investigate the differences in joint position sense between paretic and nonparetic ankles and to examine the effects of elastic therapeutic taping on joint position sense of the paretic ankle in stroke survivors. Sixteen chronic stroke survivors participated in a 2-day protocol of ankle elastic therapeutic taping on the paretic side. Active and passive joint position sense at the ankle was measured by Biodex Isokinetic III system on both the paretic and nonparetic sides before elastic therapeutic taping and only the paretic side after elastic therapeutic taping. The active and passive ankle joint position sense values were significantly (P < 0.001) lower on the paretic side than the nonparetic side before intervention. Joint position sense significantly (P < 0.001) improved for the paretic ankle after elastic therapeutic taping. Chronic stroke survivors were deficient in ankle joint position sense on the paretic side. Elastic therapeutic taping was effective in the short term to improve active and passive joint position sense.

The impact of incline and speed of treadmill on ankle muscle activity in middle-aged adults.

OBJECTIVE: Additional demands associated with changing walking incline and speed combined with normal aging related changes in muscle recruitment can make walking difficult. This study examined the effects of walking on a treadmill at different inclines and speeds on ankle muscles in healthy middle-aged adults. METHODS: Fifteen healthy subjects (10M/5F) walked on a standard treadmill at three different inclines (0°, 3°, and 6°) and speeds (self-selected, self-selected+20%, self-selected+40%). The electromyographic activity of Medial Gastrocnemius (MG), and Tibialis anterior (TA) muscles was measured during the push off phase of the gait. RESULTS: Bilateral MG muscle activity increased when subjects walked uphill compared with level walking (p < 0.05), but no changes were seen with increasing walking speed (p > 0.05). Right MG (dominant side) activity increased at all inclines, but only at 6° on left side and also MG muscle activity was delayed on the left side at faster speed (p < 0.05). CONCLUSION: The bias towards using muscles in the dominant leg in middle-aged subjects to overcome challenging walking conditions may be an age-related adaptation. These results suggest that future studies in the stroke population are needed to examine the impact of hemiparesis of the dominant leg as this group of persons post-stroke may be more likely to experience greater impairment of muscle activation patterns during walking on sloped surfaces.

Effects of treadmill incline and speed on peroneus longus muscle activity in persons with chronic stroke and healthy subjects.

OBJECTIVE: To examine the effects of walking at different inclines and speeds on Peroneus Longus (PL) muscle activation and medial gastrocnemius (MG) coactivation with PL in healthy controls and subjects with stroke. DESIGN: Nineteen persons post-stroke (13M/6F) and fifteen healthy controls (10M/5F) walked on a treadmill at different inclines (0°, 3°, and 6°) and speeds (self-selected, self-selected+20%, self-selected+40%). The electromyographic activity of the PL and MG muscles in the stance phase of gait cycle was measured. RESULTS: The paretic PL muscle activity did not change with incline, but increased at +40% speed only (p<0.05). The nonparetic PL increased at 6° incline and at faster speeds (p<0.05). In the healthy group, PL muscle activity increased only on the right side at 6° incline, but increased bilaterally at +40% faster speed (p<0.05). The timing of PL muscle activity did not change with incline (p>0.05), but was significantly delayed at +40% faster speed on the paretic side only (p<0.05). In healthy controls, PL muscle activation timing was unchanged with incline (p>0.05), but was significantly delayed at +40% speed only on the left side (p<0.05). The MG/PL amplitude and timing ratios were not significantly different between various walking conditions (p>0.05). CONCLUSION: An increase in PL activity occurs to provide ankle stability at walking speeds up to 40% faster than the self-selected speed. Important interlimb differences which may be related to leg dominance and motor control were observed in both stroke and healthy control groups in both PL muscle timing and their clinical impact should be investigated in future studies.

Functional effects of treadmill-based gait training at faster speeds in stroke survivors: a prospective, single-group study.

To examine the functional effects of walking retraining at faster than self-selected speed (SSS). Ten individuals with chronic stroke participated in a 4-week training over a treadmill at walking speeds 40% faster than SSS, three times per week, 30 min/session. Outcome measures assessed before, after, and 2 months after the end of intervention were the Timed Up and Go, the 6-Minute Walk, the 10-Meter Walk test, the Modified Ashworth Scale, SSS, and fastest comfortable speed. After 4 weeks of training, all outcome measures showed clinically meaningful and statistically significant improvements (P<0.05) that were maintained at 2 months after the end of the training. The results showed that a strategy of training at a speed 40% faster than SSS can improve functional activity in individuals with chronic stroke, with effects lasting up to 2 months after the intervention.

DNA binding and anticancer activity of novel cyclometalated platinum (II) complexes.

This study describes anticancer activity and DNA binding properties of two cyclometalated platinum (II) complexes with non-leaving lipophilic ligands; deprotonated 2-phenylpryidine (ppy): C1 and deprotonated benzo[h] quinolone (bhq): C2. Both complexes demonstrate significant anticancer activity and were capable to stimulate Caspase-III activity in Jurkat cancer cells. The results of Acridine orange/Ethidium bromide(AO/EtB), along with those of Caspase-III activity suggest that these complexes can induce apoptosis in the cancer cells. Moreover, C1 with flexible chemical structure indicates considerably higher anticancer activity than C2 which possesses a higher structural rigidity. Additionally, C2 represents a complex which is in part inducing cancer cell death due to the cell injury (necrosis). The absorption spectra of DNA demonstrate a hypochromic effect in the presence of increasing concentration of these complexes, reflecting DNA structural alteration after drug binding. Also, EtB competition assay and docking results revealed partial intercalation and DNA groove binding for the metal complexes. Overall, from the therapeutic point of view, ppy containing platinum complex (C1) is a favored anticancer agent, because it induces signaling cell death (apoptosis) in cancer cells, and lacks the necrotic effect.

DNA Binding and Anticancer Activity of Novel Cyclometalated Platinum (II) Complexes.

This study describes anticancer activity and DNA binding properties of two cyclometalated platinum (II) complexes with non-leaving lipophilic ligands; deperotonated 2-phenylpryidine (ppy): C1 and deperotonated benzo[h]quinolone (bhq): C2. Both complexes demonstrate significant anticancer activity and were capable to stimulate Caspase-III activity in Jurkat cancer cells. The results of Acridine orange/Ethidium bromide(AO/EtB), along with those of Caspase-III activity suggest that these complexes can induce apoptosis in the cancer cells. Moreover, C1 with flexible chemical structure indicates considerably higher anticancer activity than C2 which possesses a higher structural rigidity. Additionally, C2 represents a complex which is in part inducing cancer cell death due to the cell injury (necrosis). The absorption spectra of DNA demonstrate a hypochromic effect in the presence of increasing concentration of these complexes, reflecting DNA structural alteration after drug binding. Also, EtB competition assay and docking results revealed partial intercalation and DNA groove binding for the metal complexes. Overall, from the therapeutic point of view, ppy containing platinum complex (C1) is a favored anticancer agent, because it induces signaling cell death (apoptosis) in cancer cells, and lacks the necrotic effect.

The effect of shoulder core exercises on isometric torque of glenohumeral joint movements in healthy young females.

BACKGROUND: Strength improvement of the shoulder muscles is a major goal in rehabilitation or athletic conditioning programs. The purpose of this study was to determine the effect of shoulder core exercises on the isometric torque of glenohumeral joint movements. METHODS: A total of 36 healthy females with no history of shoulder injury enrolled in this study. Subjects were randomly assigned into the control group (n = 18, 22 ± 2.19 years of age) or experimental group (n = 18, 21 ± 2.05 years of age). Subjects in experimental group performed shoulder core exercises, using progressive resistance training, three times a week for six weeks. Subjects in control group performed no exercise. The isometric torque of shoulder movements were measured with Dynatorq device in isolated test positions of glenohumeral muscles at the beginning and after six weeks in both groups. RESULTS: shoulder core exercise training led to an increase in maximal isometric torques of shoulder scaption at 0° and 90° arm elevation, external and internal rotation, horizontal adduction and extension movements (p < 0.001 in all instances). No significant difference was found between initial scores and scores after six weeks in the control group (p > 0.05). CONCLUSIONS: These findings indicated that shoulder core exercise training leads to an increase in peak torque for all glenohumeral movements that can be considered in glenohumeral muscles strengthening programs.