Repeated-measures Trial Research Articles

National implementation trial of BeUpstanding™: an online initiative for workers to sit less and move more.

The online BeUpstanding™ program is an eight-week workplace-delivered intervention for desk-based workers to raise awareness of the benefits of sitting less and moving more and build a supportive culture for change. A workplace representative (the "champion") delivers the program, which includes a workshop where teams collectively choose their sit less/move more strategies. A toolkit provides the champion with a step-by-step guide and associated resources to support program uptake, delivery, and evaluation. Here we report on the main findings from the Australian national implementation trial of BeUpstanding. Recruitment (12/06/2019 to 30/09/2021) was supported by five policy and practice partners, with desk-based work teams from across Australia targeted. Effectiveness was measured via a single arm, repeated-measures trial. Data were collected via online surveys, toolkit analytics, and telephone calls with champions. The RE-AIM framework guided evaluation, with adoption/reach (number and characteristics); effectiveness (primary: self-reported workplace sitting time); implementation (completion of core components; costs); and, maintenance intentions reported here. Linear mixed models, correcting for cluster, were used for effectiveness, with reach, adoption, implementation, and maintenance outcomes described. Of the 1640 website users who signed-up to BeUpstanding during the recruitment period, 233 were eligible, 198 (85%) provided preliminary consent, and 118 (50.6%) champions consented and started the trial, with 94% (n = 111 champions) completing. Trial participation was from across Australia and across industries, and reached 2,761 staff, with 2,248 participating in the staff survey(s): 65% female; 64% university educated; 17% from a non-English speaking background. The program effectively changed workplace sitting (-38.5 [95%CI -46.0 to -28.7] minutes/8-hour workday) and all outcomes targeted by BeUpstanding (behaviours and culture), with small-to-moderate statistically-significant effects observed. All participating teams (n = 94) completed at least 5/7 core steps; 72.4% completed all seven. Most champions spent $0 (72%) or >$0-$5 (10%) per team member; most (67/70 96%) intended to continue or repeat the program. BeUpstanding can be adopted and successfully implemented by a range of workplaces, reach a diversity of staff, and be effective at creating a supportive culture for teams of desk-based workers to sit less and move more. Learnings will inform optimisation of the program for longer-term sustainability. ACTRN12617000682347.

Total sulfur amino acid requirements are higher during late gestation compared with early gestation in healthy Canadian pregnancies in a repeated-measures trial

BackgroundDietary Reference Intake (DRI) Recommendations for total sulfur amino acids (TSAAs; methionine + cysteine) during pregnancy are based on factorial calculations using data from adult males. To date, no data exist on TSAA requirements obtained directly during pregnancy. ObjectivesThe objective of this study was to examine whether TSAA requirements during early (11–20 wk) and late (31–40 wk) gestation in healthy females with singleton pregnancies are different than current recommendations, and different between early and late gestation using the indicator amino acid oxidation (IAAO) technique. MethodsTwenty-five females 20–40 y with a healthy singleton pregnancy were studied using the IAAO technique in a repeated measures design for a total of 70, 8-h d. On each study day a methionine test intake (range: 0–40 mg⋅kg−1⋅d−1) was provided in 8 hourly, isonitrogenous and isocaloric meals with cysteine excluded from the diet. Breath samples were collected at baseline and isotopic steady state of orally provided L-1-13C-Phenylalanine for measurement of phenylalanine oxidation. The requirement was determined using biphasic linear regression crossover analysis to identify a breakpoint in 13CO2 production, representing the estimated average requirement (EAR). ResultsThe TSAA requirement in healthy pregnant participants in early gestation was 11.1 mg⋅kg−1⋅d−1 {R2m = 0.79, R2c = 0.79; 95% confidence interval [CI] (8.9, 13.3 mg⋅kg−1⋅d−1)} and 15.0 mg⋅kg−1⋅d−1 (R2m = 0.72, R2c = 0.79; 95% CI [13.0, 17.0 mg⋅kg−1⋅d−1]) in late gestation. The difference between confidence intervals of the 2 breakpoints was = −3.9 ± 3.0, and statistically different. ConclusionsWe directly measured TSAA requirements in healthy pregnant mothers, and our findings suggest that requirements are lower than current DRI recommendations of 20 and 25 mg⋅kg−1⋅d−1, as the EAR, and Recommended Dietary Allowance, respectively. Late gestation TSAA needs are significantly different and increased 35% compared with early gestation. Recommendations for TSAA intake need to be tailored for gestational stage.This clinical trial was registered at clinicaltrials.gov as NCT04326322.

Swedish massage as an adjunct approach to Help suppOrt individuals Pregnant after Experiencing a prior Stillbirth (HOPES): a convergent parallel mixed-methods single-arm feasibility trial protocol

BackgroundWomen experiencing pregnancy after stillbirth experience high levels of anxiety, fear and depression. Standard antenatal care may be emotionally unsuitable for many women at this time, and there is a lack of evidence on what interventions or approaches to care might benefit these women. Therapeutic massage may assist women after stillbirth by decreasing anxiety, worry and stress.ObjectiveThis paper outlines the objectives, methodology, outcome and assessment measures for the Helping suppOrt individuals Pregnant after Experiencing a Stillbirth (HOPES) feasibility trial which evaluates massage as an adjunct approach to care for pregnant women who have experienced a prior stillbirth. It also outlines data collection timing and considerations for analysing the data.MethodsHOPES will use a convergent parallel mixed-methods, single-arm repeated measures trial design in trained massage therapists’ private clinics across Australia. HOPES aims to recruit 75 individuals pregnant after a previous stillbirth. The intervention is massage therapy treatments, and participants will receive up to five massages within a 4-month period at intervals of their choosing. Primary quantitative outcomes are the feasibility and acceptability of the massage intervention. Secondary outcomes include determining the optimal timing of massage therapy delivery and the collection of measures for anxiety, worry, stress and self-management. A thematic analysis of women’s experiences undertaking the intervention will also be conducted. A narrative and joint display approach to integrate mixed-methods data is planned.DiscussionThe HOPES study will determine the feasibility and preliminary evidence for massage therapy as an intervention to support women who are pregnant after a stillbirth.Trial registration.ClinicalTrials.gov NCT05636553. Registered on December 3, 2022, and the trial is ongoing.

Protein intake affects erythrocyte glutathione synthesis in healthy adults aged ≥60 years in a repeated-measures trial

BackgroundProtein recommendations for older adults are based on nitrogen balance data from young adults. Physiological studies using the indicator amino acid oxidation method suggest they need 30% to 50% more protein than current recommendations. We herein present glutathione (GSH) as a physiological estimate of protein adequacy in older adults. ObjectivesThe objective was to measure GSH kinetics in response to varying protein intakes in a repeated-measures design in healthy adults aged ≥60 y using the precursor-product method. MethodsSixteen healthy older adults (n = 8 male and n = 8 female; body mass index ≤30 kg/m2) were studied. Each received 4 of 6 protein intakes in random order (0.66, 0.8, 0.9, 1.1, 1.3 and 1.5 g⋅kg−1⋅d−1). At each intake level, participants underwent isotope infusion studies of 7 h duration following a 3-d adaptation to the test level of protein. On the fourth day, GSH fractional (FSR) and absolute synthesis (ASR) rates were quantified by measuring the incorporation of U-[13C2-15N]glycine into GSH at isotopic steady state. A mixed-effect change-point regression model was used to determine a breakpoint in FSR and ASR. Secondary outcomes included plasma concentrations of oxidative stress markers, homocysteine, 5-L-oxoproline (5-OP), and urinary sulfate. The effect of secondary outcomes on GSH kinetics was analyzed using a joint linear mixed-effect model and Tukey’s post hoc test. ResultsA protein intake of 1.08 g⋅kg−1⋅d−1 (95% confidence interval [CI]: 0.83, 1.32; Rm2 = 0.207; Rc2 = 0.671; P < 0.001) maximized GSH FSR. There was no effect of protein intake on concentrations of erythrocyte GSH, plasma homocysteine, oxidative stress markers, or 5-OP (P > 0.05). Protein intake had a positive effect on urinary sulfate excretion (P < 0.0001). ConclusionA protein intake of 1.08 g⋅kg−1⋅d−1 from a high-quality protein maximized GSH synthesis in adults ≥60 y. This lends support to data suggesting a requirement higher than the current recommendation.This study was registered at clinicaltrials.gov as NCT02971046.

Protein intake affects erythrocyte glutathione synthesis in young healthy adults in a repeated-measures trial

BackgroundIn 2005, the Institute of Medicine advised using methods other than nitrogen balance (NB) for determining protein requirements. Since then, protein requirements using indicator amino acid oxidation (IAAO) have been published and are higher than NB. Glutathione (GSH), a tripeptide of cysteine, glutamate, and glycine, is a principal antioxidant that can be used as a functional indicator of protein adequacy. ObjectivesThe aim of this study was to measure changes in erythrocyte GSH kinetics [fractional synthesis rate (FSR) and absolute synthesis rate (ASR)] in healthy adults following a range of protein intakes at and above the current recommendations. MethodsSixteen healthy adults [8 males and 8 females, aged 25.6 ± 0.9 y (mean ± SEM)] were studied at 4 of 6 protein intakes ranging from 0.6 to 1.5 g⋅kg-1⋅d-1. Erythrocyte GSH kinetics were assessed during a 7-h infusion of [U-13C2–15N]glycine following 2 d of adaptation to each protein intake. Blood and urine tests were performed to measure oxidative stress markers, plasma homocysteine, triglycerides, plasma amino acid concentrations, 5-L-oxoproline (5-OP), and urinary sulfate. The protein intake that maximized GSH synthesis was determined using mixed-effect change-point regression in R. Primary and secondary outcomes were analyzed using linear mixed-effects and repeated-measures analysis of variance with Tukey’s post hoc test. ResultsThe protein intake that maximized GSH FSR at 78%⋅d-1 was 1.0 g⋅kg-1⋅d-1 (95% confidence interval: 0.63, 1.39). GSH ASR was significantly lower at 0.6 and 0.8 g⋅kg-1⋅d-1 than at 1.5 g⋅kg-1⋅d-1 (2.03 and 2.17, respectively, compared with 3.71 mmol⋅L-1⋅d-1). Increasing the protein intake led to increased urinary sulfate but did not affect erythrocyte GSH concentration, plasma oxidative stress markers, triglycerides, homocysteine, or 5-OP. ConclusionsA protein intake of 1.0 g⋅kg-1⋅d-1 maximized GSH synthesis, which is in agreement with earlier IAAO-derived protein requirements of 0.93 to 1.2 g⋅kg-1⋅d-1. These findings suggest that recommendations based on NB (0.66 g⋅kg-1⋅d-1) may underestimate protein needs for adequate health.This trial was registered at clinicaltrials.gov as NCT02971046.

Efficacy of reading strategies on text-level reading comprehension in people with post-stroke chronic aphasia: A repeated measures study.

People with aphasia (PWA) frequently experience difficulties in understanding longer written content such as paragraphs or books. Reading strategies are a promising approach to treat text-level reading comprehension deficits in PWA. Nevertheless, empirical evidence for their efficacy remains rare. The primary objective of this study was to analyse the efficacy of a strategy-based intervention on text-level reading comprehension in PWA. Secondary objectives were to compare the effects of two strategy-based intervention components and to explore potential moderator effects. A protocol was published prior to data acquisition. In a repeated measures trial, 26 German participants with chronic, post-stroke aphasia participated in a waiting period without aphasia treatment (control condition) followed by a strategy-based intervention called 'Strategiebasierte Textverständnis-Therapie bei Aphasie' (StraTexT, 14 face-to-face-sessions, twice per week, 60 min each). Two strategy combinations, Intervention Micro targeting microstructure and Intervention Macro targeting macrostructure, were applied to newspaper and magazine articles. Participants were randomly allocated to two parallel groups that received these strategy combinations in interchanged sequences. Assessments were implemented before and after each period as well as 3 and 6 months after the intervention. The primary outcome measure was text-level reading comprehension measured with the total score of a German version of the Test de Compréhension de Textes (TCT-D). Secondary outcome measures addressed the self-reported perception of reading abilities, reading activities and feelings about reading (German version of the Comprehensive Assessment of Reading in Aphasia CARA reading questionnaire) as well as selected cognitive functions. The per-protocol-analysis included data from 22 participants. We found significant small improvements up to 6 months post-intervention compared to pre-intervention in the TCT-D Total (d = 0.35-0.46) as well as medium to large improvements in the CARA questionnaire (d = 0.68-0.96). Up to 3 months after the intervention, treatment-induced improvements in the TCT-D Total were significantly larger than change without treatment during the control condition. There was no evidence of moderator effects. Furthermore, we found improvements in several cognitive functions. Reading strategies can lead to long-term improvements in text-level reading comprehension and in self-reported reading abilities, feelings about reading and reading activities in aphasia. In regular clinical settings, it seems reasonable to implement both Intervention Micro and Intervention Macro. It remains important to investigate participant characteristics that contribute to treatment success. What is already known on the subject Systematic reviews and multiple case studies suggest that reading strategies are a promising approach to treat text-level reading comprehension in aphasia. The efficacy of reading strategies has been demonstrated for different populations. However, to date no group study has evaluated the efficacy of reading strategies on text-level reading comprehension in people with aphasia. What this study adds This study provides the first group-level evidence about the efficacy of a systematic strategy-based intervention in 22 people with post-stroke chronic aphasia. During 14 treatment sessions, participants applied four reading strategies to newspaper and magazine articles within two intervention components called Intervention Micro and Intervention Macro (two strategies per intervention component). We found improvements in text-level reading comprehension for at least 3 months post-intervention, as well as effects on selected cognitive functions and self-reported reading abilities, thoughts and feelings about reading and the ability to engage in reading activities. What are the clinical implications of this work? The strategies and materials evaluated in this study could be used in clinical practice with people with aphasia. In order to replicate treatment effects in clinical practice, we suggest applying the strategy combination with the same protocol features (e.g., frequency, duration, homework, product orientation) as in this study, implementing Intervention Micro and Intervention Macro sequentially in either order. As treatment response was not equal in all individuals, it seems important to investigate individual features that contribute to treatment success.

Effects of Telephone-Based Brief Motivational Interviewing on Self-Management, Medication Adherence, and Glycemic Control in Patients with Uncontrolled Type 2 Diabetes Mellitus in a Rural Community in Thailand.

Owing to the increased prevalence of type 2 diabetes mellitus (T2DM) and the high proportion of patients with uncontrolled T2DM, effective interventions for disease management are needed. The study aim was to test the effects of brief motivational interviewing (MI) on patients' self-management, medication adherence, and glycemic control. A single-group repeated measures trial was used to examine the effects of usual care only and usual care plus telephone-based brief MI. Participants were 29 patients with uncontrolled T2DM recruited from a rural primary care setting in Nakhon Sawan, Thailand. Participants received usual care during the first 4 weeks, followed by usual care plus brief MI during weeks 4-8. Outcomes of self-management, medication adherence, fasting blood sugar (FBS) levels, and hemoglobin A1c (HbA1c) levels were assessed at baseline, 4 weeks, and 8 weeks. Data were analyzed using descriptive statistics, one-way repeated measures analysis of variance, and Friedman test. Significant changes in self-management (p < 0.001), medication adherence (p < 0.001), and FBS (p < 0.05) were observed over the 8-week study. In multiple comparisons, self-management was the only parameter significantly different across baseline, 4, and 8 weeks (p <0.05, <0.001, and <0.001, respectively); medication adherence was significantly different between 4 and 8 weeks (p < 0.05), and between baseline and 8 weeks (p < 0.001); and FBS was significantly different between 4 and 8 weeks (p < 0.05). HbA1c declined over the 8-week study, but not significantly. An intervention combining telephone-based brief MI with usual care significantly increased self-management, medication adherence, and glycemic control (ie, FBS) after 4 weeks, whereas usual care only significantly increased self-management. Phone-based brief MI may be an effective way for healthcare providers to remotely enhance patients' self-management and glycemic control, thus reducing barriers related to time and geographic location.

Live and recorded music interventions for management of delirium symptoms in acute geriatric patients: Protocol for a randomized feasibility trial

ABSTRACT Introduction Delirium is an acute alteration in attention, awareness, arousal, and cognition, precipitated by a sudden illness and highly prevalent in older, frail and acutely hospitalized patients. It is associated with poor outcomes, and few effective treatment alternatives. Non-pharmacological interventions and music show promising effects, warranting further research. This pilot randomized repeated measures trial aims to test feasibility of the trial methodology, acceptability, fidelity and safety of the music interventions, suitability of the effect-outcomes. and preliminary effectiveness. Method Acute geriatric patients with delirium or subsyndromal delirium will be randomized to Preferred Recorded Music (n = 30) or Preferred Live Music (n = 30), delivered for 30 minutes, over three consecutive days. Planned feasibility outcomes will comprise recruitment rate, retention and attrition rates, percentage of adherence, deviations rates, and success of treatment fidelity. Clinical outcomes will include: (a) trajectory of delirium symptoms: level of arousal as assessed by Observational Scale of Level of Arousal (OSLA) and modified Richmond Agitation Sedation Scale (mRASS); attention, assessed using backwards tests and digit span tests; orientation and short-term memory, assessed using recall tasks and orientation questions from Memorial Delirium Assessment Scale, (b) duration of delirium, (c) length of hospital stay, and (d) use of PRN medication (benzodiazepines and antipsychotics). Discussion The trial will provide results needed to design a subsequent sufficiently powered RCT, informing on the expected recruitment, feasibility and acceptability of the interventions and assessments and preliminary effectiveness

Do posted foot orthoses alter hip biomechanics and pain during walking in women with greater trochanteric pain syndrome?

BackgroundGreater trochanteric pain syndrome (GTPS), including gluteal tendinopathy and bursitis, is a common, painful and debilitating condition. It is thought to involve overload of the gluteal tendons, which may be amplified through increased hip adduction moment (HAM) seen during gait in these individuals. Reducing the aberrant HAM may improve pain and function in this population. We aimed to determine if medially-posted foot orthoses immediately reduce HAM and pain in females with GTPS during walking gait. MethodsA double-blind, repeated-measures trial with randomised intervention order compared three conditions in 53 women with GTPS. Participants acted as their own control during baseline (everyday-shoe insole), medially-posted (active) orthosis, or flat insert (sham orthosis) walking. Data were collected via three-dimensional gait analysis for HAM, hip, pelvic, and thorax kinematics; as well as ground reaction force; and pain via the numerical rating scale. Subgroup analysis was performed based on a pronated foot-posture defined by the Foot Posture Index. ResultsA small pain reduction was found between the active orthosis and flat insert (mean difference = −0.444, p = 0.017). No difference was detected for pain between other condition comparisons. Thoracic lateral flexion increased at second-peak HAM between the baseline and active conditions (mean difference = −0.917, p = 0.040). No differences were detected for HAM, remaining kinematic or kinetic variables, or ground reaction force data across the three conditions. No significant differences were detected between any of the three conditions for biomechanical or pain data in the pronated-foot subgroup. SignificanceA medially-posted foot orthosis did not immediately alter gait biomechanics or provide a clinically meaningful pain reduction in women with GTPS. There is uncertainty regarding the clinical benefit of orthoses in the management of GTPS. Longer-term follow-up or the use of customised orthoses may produce different outcomes and should be explored in future research.

Exploring Force Production Reliability across Different Levels of Clinical Experience during a Simulated One-handed Instrument-Assisted Soft Tissue Mobilization Treatment: A Pilot Study.

BackgroundInstrument-assisted soft tissue mobilization (IASTM) is a commonly utilized intervention for musculoskeletal pain and dysfunction. However, little is known regarding the reliability of forces applied by clinicians of different experience levels during an IASTM intervention.PurposeThe purpose of this pilot study was to assess intra-clinician reliability of IASTM force (i.e., mean normal force) during a simulated, one-handed stroke IASTM intervention across different levels of IASTM clinical experience.DesignDescriptive laboratory study.MethodsThe researchers conducted a repeated measures trial in a laboratory setting with a convenience sample of ten participants who had previously completed professional IASTM training. Participants performed 15 one-handed sweeping strokes with an IASTM instrument on a skin simulant attached to a force plate for a standardized hypothetical treatment scenario. The participants performed the treatment on two separate days, 24-48 hours apart. The researchers examined the intra-rater reliability for average (mean) normal forces using Bland-Altman (BA) plots and Coefficient of Variation (CV) values.ResultsThe BA plot results indicated all participants (professional athletic training students = 4, athletic trainers = 6; males = 5, females = 5; age = 32.60 ± 8.71 y; IASTM experience = 3.78 ± 4.10 y), except participant D (1.9N, 190g), were consistently reliable within 1N (100g) or less of force for mean differences and within the maximum limits of agreement around 3.7N (370g). Most participants’ CV scores ranged between 8 to 20% supporting reliable force application within each treatment session.ConclusionThe data indicated that IASTM trained clinicians could produce consistent forces within and across treatment sessions irrespective of clinical experience.Level of Evidence3

Dental hygiene students' participation as subjects in a randomized controlled trial: A full evidence-based dentistry experience.

Demonstrate that dental hygiene students' participation in a randomized controlled trial comparing the plaque-removing capability of two toothbrushes provides a fuller understanding of the factors affecting the potential application of research to practice. All students (N=18) in a baccalaureate dental hygiene class were engaged in the design of a randomized controlled trial using the Consolidated Standards of Reporting Trials (CONSORT) standard and then participated as subjects in a staggered, repeated measures trial using plaque removal as the dependent variable and brush type, brush head wear, and time in study as independent variables. A debriefing of student participation and lessons learned from analyzing the results was conducted. The study found statistically significant differences in plaque removal capability. Brush type accounted for only 4% of the variance, while measures of brush head wear were inconsistent, and time in the study ("experimental fatigue") accounted for the most variance (9%). Students recognized and confirmed by their personal experiences that research that fails to focus on variance can create an overly optimistic impression of research effectiveness. There was strong agreement that subjects/patients vary widely and that performance depends on multiple factors. Dental hygiene students who participated as subjects in a randomized controlled trial comparing toothbrushes for plaque removal capacity felt that full analysis to account for all sources of variance and estimate the magnitude of measures of effect add to the value of reported research. Variation across patients is important in practice, if often overlooked as an "error" in the literature.

Chronic Ingestion of Bicarbonate-Rich Water Improves Anaerobic Performance in Hypohydrated Elite Judo Athletes: A Pilot Study.

In combat sports, anaerobic power and anaerobic capacity determine sport performance and the dominant metabolic pathways. The decline in performance during exercise that is attributed to the cumulative effects of fatigue, including excessive accumulation of metabolites, depletion of energy substrates, and water and electrolyte disturbances, seems to be of greatest significance. In our experiment, we evaluated the effectiveness of three weeks of bicarbonate-rich water ingestion on anaerobic performance in a state of hydration and dehydration in elite judo athletes. Eight male, elite judo athletes participated in two single-blind, repeated-measures trials. They were assigned to two hydration protocols, ingesting low mineralized table water and bicarbonate-rich water. Anaerobic performance was evaluated by two 30 s Wingate tests for lower and upper limbs, respectively, under conditions of hydration as well as exercise-induced dehydration. Resting, post-ingestion, and post-exercise concentrations of bicarbonate (HCO3), urine osmolality (UOSM), urine specific gravity (UGRAV), and lactate (La) were measured. The current investigation assessed two related factors that impair anaerobic performance—hypohydration and buffering capacity. High-bicarbonate water ingestion improved buffering capacity, and we demonstrated the potential role of this mechanism and its phenomenon in masking the adverse effects of dehydration in the context of repeated high-intensity anaerobic exercise (HIAE).

Effect of Posterior Pelvic Tilt Taping on Abdominal Muscle Thickness and Lumbar Lordosis in Individuals With Chronic Low Back Pain and Hyperlordosis: A Single-Group, Repeated-Measures Trial

ObjectiveThe purpose of this study was to investigate the effect of posterior pelvic tilt taping (PPTT) on lumbar lordosis, pain, disability, and abdominal muscle thickness in individuals with nonspecific chronic low back pain with hyperlordosis. MethodsA prospective, single-group, repeated-measures design was conducted with 31 individuals with nonspecific chronic low back pain (16 men, 15 women) with hyperlordosis (mean ± SD = 59.3° ± 2.9°). Participants’ mean age, pain, disability, and lumbar lordosis were, respectively, 35.7 ± 9.9 years, 5.1 ± 1.3, 26.8 ± 11.5, and 59.3° ± 2.9°. The thickness of the abdominal muscles on both sides was measured in the crook lying position by ultrasound imaging. PPTT was performed on both sides. Pain intensity, functional disability, lumbar lordosis angle, and abdominal muscle thickness were measured before PPTT (W0), 1 week after PPTT (W1), and 1 week after PPTT removal (W2). ResultsAnalysis revealed significant reductions in lumbar lordosis, pain, and disability, and increased abdominal muscle thickness, at W1 and W2 compared with W0 (P < .001). There were no significant differences in lumbar lordosis or abdominal muscle thickness between W1 and W2. ConclusionThe current study showed in a small group of participants that 1 week of PPTT may improve lumbar lordosis, pain, disability, and abdominal muscle thickness in individuals with nonspecific chronic low back pain with hyperlordosis.

Efficacy of spoken word comprehension therapy in patients with chronic aphasia: a cross-over randomised controlled trial with structural imaging

ObjectiveThe efficacy of spoken language comprehension therapies for persons with aphasia remains equivocal. We investigated the efficacy of a self-led therapy app, ‘Listen-In’, and examined the relation between brain structure...

Muscle activity in children with spastic unilateral cerebral palsy when walking with ankle-foot orthoses: an explorative study

BackgroundA hinged ankle-foot orthosis is prescribed for children with spastic unilateral cerebral palsy to improve gait function by correcting spastic equinus. However, little is known about how orthotic management relates to muscle activity during walking in this population. Research questionDoes muscle activity in medial gastrocnemius and tibialis anterior change in children with spastic unilateral cerebral palsy when walking with hinged ankle-foot orthoses featuring two different footplate designs? MethodsIn this prospective, repeated-measures trial, electromyographic activity in medial gastrocnemius and tibialis anterior was recorded from 17 children (mean age: 8.4 years ± 1.3 years) with spastic unilateral cerebral palsy walking barefoot and with two designs of hinged ankle-foot orthosis. The orthotic devices consisted of custom-made hinged ankle-foot orthoses with unmodified, flatter footplates and rectified, contoured footplates. Primary outcome measures were total muscle activity, quantified as the area under a linear envelope, and relative change in profiles of muscle activity, depicted by curves of mean difference with 95% confidence bands. ResultsNo statistical difference was found in total activity of either muscle for the ankle-foot orthosis with an unmodified footplate but a significant reduction in muscle activity of tibialis anterior was seen for the ankle-foot orthosis with a contoured footplate relative to barefoot walking. Profiles of change in muscle activity were significantly altered for both shank muscles between all walking conditions. The most pronounced differences were decreased activity in medial gastrocnemius during early stance phase and lower activity in tibialis anterior during swing phase with orthotic devices. SignificanceOrthotic management with hinged ankle-foot orthoses may mitigate spastic activation of medial gastrocnemius in children with spastic unilateral cerebral palsy but also appears to functionally inactivate tibialis anterior during gait. The hinged ankle-foot orthosis with an unmodified footplate corresponded with better performance by facilitating more functional muscle activity while impeding spastic response.

Acute Soy Supplementation Improves 20-km Time Trial Performance, Power, and Speed.

Isoflavones, a chemical class of phytoestrogens found in soybeans and soy products, may have biological functions similar to estradiol. After binding with ERβ or perhaps independently of estrogen receptors, isoflavones may augment vascular endothelial relaxation, contributing to improved limb blood flow. To determine if acute fermented soy extract supplementation influences 20-km time trial cycling performance and cardiac hemodynamics compared with a placebo. Subjects included 25 cyclists and triathletes (31 ± 8 yr, V˙O2peak: 55.1 ± 8.4 mL·kg·min). Each subject completed a V˙O2peak assessment, familiarization, and two 20-km time trials in randomized order after ingestion of a fermented soy extract supplement or placebo. The fermented soy extract consisted of 30 g powdered supplement in 16 fl. ounces of water. The placebo contained the same quantities of organic cocoa powder and water. Each trial consisted of 60 min of rest, 30 min at 55% Wpeak, and a self-paced 20-km time trial. Soy supplementation elicited a faster time to 20-km completion (-0.22 ± 0.51 min; -13 s), lower average HR (-5 ± 7 bpm), and significantly greater power (7 ± 3 W) and speed (0.42 ± 0.16 km·h) during the last 5 km of the time trial compared with placebo. Analysis of the results by relative fitness level (<57 vs ≥ 57 mL⋅kg⋅min) indicated that those with a higher level of fitness reaped the largest performance improvement alongside a reduced HR (-5 ± 7 bpm). Ingestion of a fermented soy extract supplement improved sprint-distance performance through improvements in both power and speed. For those with great aerobic fitness, soy supplementation may help to decrease cardiac demand alongside performance improvement.

Results of a randomized trial comparing aerobic exercise and tai chi on cardiovascular function, cytokines and metabolic markers in survivors of solid tumors

There is a high incidence of hyperlipidemia, increased body fat, decreased aerobic performance, function and psychological distress in long-term survivors of cancer. This study compares the efficacy of Tai Chi (TC) vs. aerobic exercise (AE) in impacting some of these factors in adult survivors of solid tumors. We performed an unblinded randomized, repeated measures trial in adult cancer survivors who were free of metastatic disease and had not received chemotherapy for 24 months. Participants were randomized to standard 12 week instructor-led TC program, 12 week supervised AE, or waitlist (WL). WL patients were randomized to TC or AE after 12 weeks and were included in respective group analyses. Clinical variables and serum analytes were compared at baseline (T 0 ), 6 (T 1 ) and 13 (T 2 ) weeks. We measured inflammatory cytokines and growth factors: IL1b, IL6, IL8, IL10, eotaxin, GCSF, INF-g, MCP-1, PDGF-bb, and TNF-a; hormones: cortisol, insulin; and kynurenine using Elisa or Bio-plex assays. Paired group tests were performed along with analysis of unpaired analyte levels between groups for several analytes when repeated measures were not attainable. Forty-one participants completed all phases of the study. Intervention assignments are presented in Table 1. In (T 2— T 0 ) cardiovascular comparisons, the only near significant difference that was detected, was a drop in post-exercise systolic blood pressure in the TC group ( P = 0.06). There was a significant decrease in insulin ( P > 0.05) and IL10 ( P = 0.01) and a greater drop in TNFa ( P = 0.02) in the AE treated group. There was a trend for decrease of PDGF ( P = 0.06) in the TC group (Table 2). AE and TC interventions lead to different shifts in serum analyte levels. AE may offer therapeutic benefit in reducing metabolic and inflammatory markers, IL10, TNF-a and insulin. TC does not.

Effectiveness of a Mindfulness-Based Intervention in the Management of Musculoskeletal Pain in Nursing Workers

BackgroundChronic pain is a prevalent disorder in nursing workers worldwide. Several studies have proposed measures to mitigate this critical scenario. Mindfulness-based interventions (MBI) have been found to have promising results in the treatment of this disorder. AimsTo quantify the effectiveness of an adapted mindfulness program (AMP) in the management of musculoskeletal pain (MSP) in nursing technicians of a Brazilian university hospital. DesignThis study was a clinical, prospective, open, repeated measures trial, with data collection between January and July 2015. SettingsBrazilian university hospital. Participants/SubjectsSixty-four female nursing technicians with a mean age of 47.01 years (standard deviation = 9.50) with chronic pain symptoms. MethodsSixty-four female nursing technicians with a mean age of 47.01 years (standard deviation = 9.50) and MSP participated in this prospective study. Before the intervention (T0), scores of anxiety, depression, mindfulness, musculoskeletal complaints, pain catastrophizing, self-compassion, and perception of quality of life were quantified. These scores were reevaluated after 8 weeks (T1) and 12 weeks (T2) of weekly AMP sessions (60 minutes each). The variables were evaluated by analysis of variance for repeated measures, followed by the Bonferroni test. ResultsAMP reduced the scores of musculoskeletal symptoms, anxiety, depression, and pain catastrophizing (p < .001). A significant increase was identified in self-compassion scores and perception of quality of life in the physical, psychological, and overall assessment (p ≤ .04). Positive effects of AMP occurred at T1 and remained unchanged at T2. ConclusionAMP contributed to a reduction in painful symptoms and improved the quality of life of nursing workers, with a lasting effect until the 20th week of follow-up, indicating utility as an effective strategy for the management of MSP in the group studied.

Effects of an Integrative Nursing Intervention on Pain in Critically Ill Patients: A Pilot Clinical Trial.

Pain, a persistent problem in critically ill patients, adversely affects outcomes. Despite recommendations, no evidence-based nonpharmacological approaches for pain treatment in critically ill patients have been developed. To investigate the effects of a multimodal integrative intervention on the incidence of pain and on secondary outcomes: intensity of pain, hemodynamic indices (systolic and mean arterial pressure, heart rate), anxiety, fear, relaxation, optimism, and sleep quality. A randomized, controlled, double-blinded repeated-measures trial with predetermined eligibility criteria was conducted. The intervention included relaxation, guided imagery, moderate pressure massage, and listening to music. The primary outcome was incidence of pain (score on Critical Care Pain Observation Tool > 2). Other outcomes included pain ratings, hemodynamic measurements, self-reported psychological outcomes, and quality of sleep. Repeated-measures models with adjustments (baseline levels, confounders) were used. Among the 60 randomized critically ill adults in the sample, the intervention group experienced significant decreases in the incidence (P = .003) and ratings of pain (P < .001). Adjusted models revealed a significant trend for lower incidence (P = .002) and ratings (P < .001) of pain, systolic arterial pressure (P < .001), anxiety (P = .01), and improved quality of sleep (P = .02). A multimodal integrative intervention may be effective in decreasing pain and improving pain-related outcomes in critically ill patients.

Different types of bhastrika pranayama: repeated measures trials with different treatments to study the trend of the effects on static balance ability

PurposeThe objective of the study was to find out the trend of the effects of 4 varieties of bhastrika pranayama on static balance ability.MethodsThe total of 75 male students were selected as subjects. The age of the subjects ranged 17–25 years. The participants were divided randomly into 5 groups, 15 students each. They practiced 4 varieties of bhastrika pranayama.ResultsQuadratic components for overall trends were found significant in static balance ability. A significant difference was observed between linear components of the trends for the treatment groups and the control group in static balance ability. Also, a significant difference was noted between quadratic components of the trends for the treatment groups and the control group as for static balance ability.ConclusionsThere was a significant difference among the adjusted post-test means of 4 experimental groups and the control group in static balance ability.