Between-group Comparison Of Change Research Articles

Effect of Percutaneous Electric Stimulation with High-Frequency Alternating Currents on the Sensory-Motor System of Healthy Volunteers: A Double-Blind Randomized Controlled Study

Former studies investigated the application of high-frequency alternating currents (HFAC) in humans for blocking the peripheral nervous system. The present trial aims to assess the effect of HFAC on the motor response, somatosensory thresholds, and peripheral nerve conduction when applied percutaneously using frequencies of 10 kHz and 20 kHz in healthy volunteers. A parallel, placebo-controlled, double-blind, randomized clinical trial was conducted. Ultrasound-guided HFAC at 10 kHz and 20 kHz and sham stimulation were delivered to the median nerve of 60 healthy volunteers for 20 min. The main assessed variables were the maximum isometric flexion strength (MFFS) of the index finger, myotonometry, pressure pain threshold (PPT), mechanical detection threshold (MDT), and sensory nerve action potential (SNAP). A decrease in the MFFS is observed immediately postintervention compared to baseline, both in the 10 kHz group (−8.5%; 95% CI −14.9 to −2.1) and the 20 kHz group (−12.0%; 95% CI −18.3 to −5.6). The between-group comparison of changes in MFFS show a greater reduction of −10.8% (95% CI −19.8 to −1.8) immediately postintervention in the 20 kHz compared to the sham stimulation group. The percutaneous stimulation applying 20 kHz HFAC to the median nerve produces a reversible postintervention reduction in strength with no adverse effects.

A randomised controlled study of the effectiveness of breathing retraining exercises taught by a physiotherapist either by instructional DVD or in face-to-face sessions in the management of asthma in adults.

Asthma control is suboptimal, resulting in quality of life (QoL) impairment and costs. Breathing retraining exercises have evidence of effectiveness as adjuvant treatment, but are infrequently used. To transfer the contents of a brief (three-session) physiotherapist-delivered breathing retraining programme to a digital versatile disc (DVD) and booklet format; to compare the effectiveness of the self-guided intervention with that of 'face-to-face' physiotherapy and usual care for QoL and other asthma-related outcomes; to perform a health economic assessment of both interventions; and to perform a process evaluation using quantitative and qualitative methods. Parallel-group three-arm randomised controlled trial. General practice surgeries in the UK. In total, 655 adults currently receiving asthma treatment with impaired asthma-related QoL were randomly allocated to the DVD (n = 261), physiotherapist (n = 132) and control (usual care) (n = 262) arms in a 2 : 1 : 2 ratio. It was not possible to blind participants but data collection and analysis were performed blinded. Physiotherapy-based breathing retraining delivered through three 'face-to-face' respiratory physiotherapist sessions or a self-guided programme (DVD plus our theory-based behaviour change booklet) developed by the research team, with a control of usual care. The primary outcome measure was asthma-specific QoL, measured using the Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes included asthma symptom control [Asthma Control Questionnaire (ACQ)], psychological state [Hospital Anxiety and Depression Scale (HADS)], hyperventilation symptoms (Nijmegen questionnaire), generic QoL [EuroQol-5 Dimensions (EQ-5D)], assessments of airway physiology (spirometry) and inflammation (exhaled nitric oxide) and health resource use and costs. Assessments were carried out at baseline and at 3, 6 and 12 months post randomisation. Patient engagement and experience were also assessed using quantitative and qualitative methods. Primary efficacy analysis was between-group comparison of changes in AQLQ scores from baseline to 12 months in the intention-to-treat population with adjustments for prespecified covariates. Significant improvements occurred in the DVD group compared with the control group [adjusted mean difference 0.28, 95% confidence interval (CI) 0.11 to 0.44; p < 0.001] and in the face-to-face physiotherapy group compared with the control group (adjusted mean difference 0.24, 95% CI 0.04 to 0.44; p < 0.05), with equivalence between the DVD and the face-to-face physiotherapy groups (adjusted mean difference 0.04, 95% CI -0.16 to 0.24). In all sensitivity analyses, both interventions remained significantly superior to the control and equivalence between the interventions was maintained. In other questionnaire outcome measures and in the physiological measures assessed, there were no significant between-group differences. Process evaluations showed that participants engaged well with both of the active interventions, but that some participants in the DVD arm would have liked to receive tuition from a professional. Asthma health-care costs were lower in both intervention arms than in the control group, indicating 'dominance' for both of the interventions compared with the control, with lowest costs in the DVD arm. The rate of adverse events was lower in the DVD and face-to-face physiotherapy groups than in the control group. Only 10% of the potentially eligible population responded to the study invitation. However, breathing retraining exercises improved QoL and reduced health-care costs in adults with asthma whose condition remains uncontrolled despite standard pharmacological therapy, were engaged with well by patients and can be delivered effectively as a self-guided intervention. The intervention should now be transferred to an internet-based platform and implementation studies performed. Interventions for younger patients should be developed and trialled. Current Controlled Trials ISRCTN88318003. This project was primarily funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 53. See the NIHR Journals Library website for further project information. Additional financial support was received from Comprehensive Local Research Networks.

High-Intensity Interval Training in Patients With Heart Failure With Reduced Ejection Fraction.

Small studies have suggested that high-intensity interval training (HIIT) is superior to moderate continuous training (MCT) in reversing cardiac remodeling and increasing aerobic capacity in patients with heart failure with reduced ejection fraction. The present multicenter trial compared 12 weeks of supervised interventions of HIIT, MCT, or a recommendation of regular exercise (RRE). Two hundred sixty-one patients with left ventricular ejection fraction ≤35% and New York Heart Association class II to III were randomly assigned to HIIT at 90% to 95% of maximal heart rate, MCT at 60% to 70% of maximal heart rate, or RRE. Thereafter, patients were encouraged to continue exercising on their own. Clinical assessments were performed at baseline, after the intervention, and at follow-up after 52 weeks. Primary end point was a between-group comparison of change in left ventricular end-diastolic diameter from baseline to 12 weeks. Groups did not differ in age (median, 60 years), sex (19% women), ischemic pathogenesis (59%), or medication. Change in left ventricular end-diastolic diameter from baseline to 12 weeks was not different between HIIT and MCT (P=0.45); left ventricular end-diastolic diameter changes compared with RRE were -2.8 mm (-5.2 to -0.4 mm; P=0.02) in HIIT and -1.2 mm (-3.6 to 1.2 mm; P=0.34) in MCT. There was also no difference between HIIT and MCT in peak oxygen uptake (P=0.70), but both were superior to RRE. However, none of these changes was maintained at follow-up after 52 weeks. Serious adverse events were not statistically different during supervised intervention or at follow-up at 52 weeks (HIIT, 39%; MCT, 25%; RRE, 34%; P=0.16). Training records showed that 51% of patients exercised below prescribed target during supervised HIIT and 80% above target in MCT. HIIT was not superior to MCT in changing left ventricular remodeling or aerobic capacity, and its feasibility remains unresolved in patients with heart failure. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00917046.

Beneficial effect of a polyphenol-rich diet on cardiovascular risk: a randomised control trial

ObjectivesThere is previous epidemiological evidence that intake of polyphenol-rich foods has been associated with reduced cardiovascular disease risk. We aimed to investigate the effect of increasing dietary polyphenol intake on...

Efficacy of probiotic supplementation on quality of life and pulmonary symptoms due to sulfur mustard exposure: a randomized double-blind placebo-controlled trial

Objective: This study investigated the efficacy and safety of supplementation with probiotics in improving chronic pulmonary symptoms due to sulfur mustard (SM) exposure. Methods: In a randomized double-blind placebo-controlled study, 65 subjects suffering from chronic pulmonary complications of SM were assigned to one probiotic capsule (1 × 109 CFU containing seven strains of lactic acid-producing bacteria) every 12 h or an identical placebo for six weeks. Serum high-sensitivity C-reactive protein (CRP) concentrations, pulmonary function tests (FEV1, FEV1/FVC and MMEF 25–75%) and COPD assessment test (CAT) were assessed at baseline and at the end of trial. Results: The groups were comparable in baseline characteristics. There were significant improvements in FEV1/FVC in the probiotic but not in placebo group. CAT scores were decreased in both study groups. However, between-group comparison of changes in the assessed parameters reached statistical significance only for CAT score (p < 0.001). There was no report of adverse events during the course of trial. Conclusions: Findings of the present trial favor the efficacy of probiotic supplementation in improving the pulmonary symptoms of SM-exposed subjects.

Lower Integrated Muscle Protein Synthesis in Masters Compared with Younger Athletes.

The objective of this study is to compare the integrated muscle protein synthesis (MPS) rates of masters and younger triathletes over three consecutive days of intense endurance training. Recovery of cycling performance, after muscle-damaging running, was also compared between groups. Five masters (age, 53 ± 2 yr; V˙O2max, 55.7 ± 6.9 mL·kg·min) and six younger (age, 27 ± 2 yr; V˙O2max, 62.3 ± 1.5 mL·kg·min) trained triathletes volunteered for the study. Baseline skeletal muscle and saliva were initially sampled, after which a 150-mL bolus of deuterium oxide (70%) was consumed. Participants then completed a 30-min downhill run; three 20-km cycling time trials (TT) were completed 10, 24, and 48 h after the run. Saliva was collected each morning, and skeletal muscle was again sampled 72 h after the run; both were used for MPS analysis. Diet was controlled throughout the study. Over 3 d, masters triathletes showed a significantly lower myofibrillar fractional synthetic rate (1.49% ± 0.12%·d) compared with the younger (1.70% ± 0.09%·d) triathletes (P = 0.009, d = 1.98). There was also a trend for masters triathletes to produce a slower cycle TT (-3.0%, d = 0.46) than younger triathletes (-1.4%, d = 0.29) at 10 h postrun in comparison with the baseline performance. The between-group comparison of change was moderate (d = 0.51), suggesting slower acute recovery among masters triathletes. The present data show lower MPS rates in well-trained masters triathletes over 3 d of training, and this likely contributes to poorer muscle protein repair and remodeling. Furthermore, acute recovery of cycle TT performance tended to be poorer in the masters triathletes.

Osteopathic Manipulative Therapy in Women With Postpartum Low Back Pain and Disability: A Pragmatic Randomized Controlled Trial.

Persistent low back pain (LBP) is a common complaint among women during and after pregnancy, and its effects on quality of life can be disabling. To evaluate the effectiveness of osteopathic manipulative therapy (OMTh; manipulative care provided by foreign-trained osteopaths) in women with persistent LBP and functional disability after childbirth. A pragmatic randomized controlled trial was conducted among a sample of women with a history of pregnancy-related LBP for at least 3 months after delivery. Participants were identified from the general population in Germany. By means of external randomization, women were allocated to an OMTh group and a waitlist control group. Osteopathic manipulative therapy was provided 4 times at intervals of 2 weeks, with a follow-up after 12 weeks. The OMTh was tailored to each participant and based on osteopathic principles. The participants allocated to the control group did not receive OMTh during the 8-week study; rather, they were put on a waiting list to receive OMTh on completion of the study. Further, they were not allowed to receive any additional treatment (ie, medication, physical therapy, or other sources of pain relief) during the study period. The main outcome measures were pain intensity as measured by a visual analog scale and the effect of LBP on daily activities as assessed by the Oswestry Disability Index (ODI). A total of 80 women aged between 23 and 42 years (mean [SD], 33.6 [4.5] years) were included in the study, with 40 in the OMTh group and 40 in the control group. Pain intensity decreased in the OMTh group from 7.3 to 2.0 (95% CI, 4.8-5.9; P&lt;.001) and in the control group from 7.0 to 6.5 (95% CI, -0.2 to -0.9; P=.005). The between-group comparison of changes revealed a statistically significant improvement in pain intensity in the OMTh group (between-group difference of means, 4.8; 95% CI, 4.1-5.4; P&lt;.001) and level of disability (between-group difference of means, 10.6; 95% CI, 9.9-13.2; P&lt;.005). The follow-up assessment in the OMTh group (n=38) showed further improvement. During 8 weeks, OMTh applied 4 times led to clinically relevant positive changes in pain intensity and functional disability in women with postpartum LBP. Further studies that include prolonged follow-up periods are warranted. (German Clinical Trials Register: DRKS00006280.).

The effects of stair gait exercise on static balance ability of stroke patients.

[Purpose] This study examined the effects of stair gait exercise on the static balance ability of chronic stroke patients. [Subjects and Methods] The thirty stroke patients who participated in this experiment were randomly assigned to an experimental (n=15) or control (n=15) group. The experimental group performed stair gait exercise for 30 minutes, while the control group performed flat surface gait exercise for 30 minutes. The programs lasted four weeks, with both groups performing the exercises three times per week for 30 minutes each time. The stability balance ability of subjects was measured and compared before and after the interventions. [Results] The results of the experimental group showed a significantly different values, but those of the control group did not. Between-group comparison of changes in the anterior/posterior length in the limit of stability revealed significant increases in the experimental group but no significant increase in the control group. Only the surface area ellipse of Romberg, the length of Romberg, and length/area of Romberg showed significant differences between the two groups after the interventions. [Conclusion] The static balance ability improved in the group that performed the stair gait exercise. This study provides important data for identifying the recovery of balance ability through rehabilitation exercises in patients with nervous system diseases.

Comparison of 2 Hyaluronic Acid Drugs for the Treatment of Temporomandibular Joint Osteoarthritis

To compare the effectiveness of 2 treatment protocols providing 5 weekly temporomandibular joint (TMJ) arthrocenteses immediately followed by injections of 2 different molecular weight hyaluronic acid (HA) drugs to manage symptoms in patients with inflammatory-degenerative TMJ disease. Patients with a Research Diagnostic Criteria for Temporomandibular Disorders diagnosis of osteoarthritis were randomly assigned to 1 of 2 study groups receiving either low- or medium-molecular weight HA after arthrocentesis. The level of maximum pain at chewing was the primary outcome variable, and maximum pain at rest, subjective chewing efficiency, functional limitation, treatment tolerability, perceived treatment effectiveness, and jaw range-of-motion function in millimeters were the secondary outcomes. All variables were assessed and compared between groups at baseline, at the end of treatment, and 3 months later. Forty subjects entered the study. At the end of the follow-up period, all the outcome variables improved in both groups of patients. A between-group comparison of changes over time showed that differences were not significant for any of the outcome variables, that is, pain at chewing (F = 0.056, P = .815), pain at rest (F = 0.383, P = .541), chewing efficiency (F = 0.050, P = .825), functional limitation (F = 0.268, P = .609), and mouth opening (F = 0.003, P = .954). In addition, no between-group differences were shown for perceived treatment effectiveness and treatment tolerability. Similar positive effectiveness was shown for 2 treatment protocols for TMJ osteoarthritis (ie, 5-session single-needle arthrocentesis plus low- or medium-molecular weight HA).

Are the Eutrophic Effects of Angiotensin Receptor Blockers Real?

HomeHypertensionVol. 48, No. 4Are the Eutrophic Effects of Angiotensin Receptor Blockers Real? Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBAre the Eutrophic Effects of Angiotensin Receptor Blockers Real? Flávio Danni. Fuchs Flávio Danni. FuchsFlávio Danni. Fuchs Division of Cardiology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil Search for more papers by this author Originally published21 Aug 2006https://doi.org/10.1161/01.HYP.0000238605.34864.9fHypertension. 2006;48:E18Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: August 21, 2006: Previous Version 1 To the Editor:In a laborious experimental study, Savoia et al1 concluded that the addition of valsartan but not atenolol to the antihypertensive treatment decreased the resistance artery media/lumen ratio of diabetic patients. On the basis of such a finding, the authors suggest that it may be preferable to achieve tight blood pressure (BP) control by using angiotensin receptor blockers in addition to other antihypertensive agents to improve vascular structure and reduce cardiovascular risk in diabetic hypertensive patients. I do believe that this advantage was not clearly demonstrated in this study, and even if it was done, it could not be extended to other antihypertensive agents.The lower efficacy of atenolol in terms of prevention of cardiovascular events was demonstrated repeatedly in elderly patients.2 At least in this age group, atenolol should not be used anymore as first-line therapy or as a comparison drug in clinical trials.3 Probably most of the lower efficacy of atenolol in this setting is attributable to a lower BP-lowering effect in this age group, a phenomenon evident in the first 6 months of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm trial.3 In the experiment of Savoia et al,1 patients were ≈60 years old, on the average, in the atenolol group. The authors assumed that BP did not vary between groups at the end of the experiment, but the data suggest the contrary. Systolic BP was 4.8 mm Hg lower in the valsartan group, and pulse pressure 2.4 mm Hg. The absence of formal statistical significance may be secondary to a β error, in view of the small sample size of the experiment. Moreover, similar office BP values may conceal substantial differences in BP along the 24-hour period, as was shown in the Heart Outcomes Prevention Evaluation trial.4My main point, however, is related to the statistical analysis of this experiment. The analysis based on the within-group statistics in experiments with 2 groups is questionable. The right approach seems to be to perform a between-group comparison of changes of variation in the media/lumen ratio or any other parameter or to use the significance of F value for the group/time interaction in repeated measurements and the multiple factors ANOVA procedure. In addition, the groups differed substantially in terms of potential confounding variables, such as age (patients in the atenolol group were 4.5 years older, on average), baseline diabetes control (worst in the valsartan group), and mainly BP at the end of and presumably during the experiment. An ANCOVA procedure for changes (after minus before values) of the media/lumen ratio controlling for confounding is required in this case to identify an independent drug effect. And finally, media thickness was unchanged in both groups after the experiment, showing that the effect, if any, was restricted to arteriolar lumen (again a trend, not statistically significant), in accordance with the between-group difference in BP.These shortcomings cast doubt on the internal validity of this experiment, which does not support the preference for any type of antihypertensive agent to reach tight BP control in patients with diabetes. The importance of the BP versus eutrophic effects of antagonists of the renin–angiotensin system is still an open issue and requires further clinical and experimental investigations.DisclosuresNone.1 Savoia C, Touyz RM, Endemann DH, Pu Q, Ko EA, De Ciuceis C, Schiffrin EL. Angiotensin receptor blocker added to previous antihypertensive agents on arteries of diabetic hypertensive patients. Hypertension. 2006; 48: 271–277.LinkGoogle Scholar2 Carlberg B, Samuelsson O, Lindholm LH. Atenolol in hypertension: is it a wise choice? Lancet. 2004; 364: 1684–1689.CrossrefMedlineGoogle Scholar3 Fuchs FD, Gus M, Ribeiro JP. ASCOT-BPLA [letter]. Lancet. 2006; 367: 205.CrossrefGoogle Scholar4 Svensson P, Faire U, Sleight P, Yusuf S, Östergren J. Comparative effects of ramipril on ambulatory and office blood pressures: A HOPE substudy. Hypertension. 2001; 38: e28–e32.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Fuchs F (2018) Prevention and Treatment Essentials of Hypertension, 10.1007/978-3-319-63272-8_4, (101-145), . Savoia C, Touyz R and Schiffrin E (2006) Response to Are the Eutrophic Effects of Angiotensin Receptor Blockers Real?, Hypertension, 48:4, (E19-E19), Online publication date: 1-Oct-2006. October 2006Vol 48, Issue 4 Advertisement Article InformationMetrics https://doi.org/10.1161/01.HYP.0000238605.34864.9fPMID: 16923991 Originally publishedAugust 21, 2006 PDF download Advertisement SubjectsACE/Angiotensin Receptors/Renin Angiotensin SystemRemodelingSmooth Muscle Proliferation and Differentiation