Co-activation during gait following anterior cruciate ligament reconstruction

BackgroundHeightened co-activation of the quadriceps and hamstrings has been reported following anterior cruciate ligament reconstruction during various tasks, and may contribute to post-traumatic osteoarthritis risk. However, it is unclear if this phenomenon occurs during walking or how co-activation influences gait biomechanics linked to changes in joint health.MethodsCo-activation and gait biomechanics were assessed in 50 individuals with ACLR and 25 healthy controls. Biomechanical outcomes included knee flexion displacement, peak vertical ground reaction force magnitude and rate, peak internal knee extension and valgus moments and rates, sagittal knee stiffness, and the heelstrike transient. Co-activation was calculated for the flexors and extensors collectively (i.e. composite), the medial musculature, and the lateral musculature.FindingsComposite co-activation was greater in the ACLR limb compared to the contralateral limb and the control cohort during the preparatory and heelstrike phases of gait, and co-activation of the medial musculature was greater in the ACLR limb compared to the control cohort during the heelstrike phase. Greater co-activation in multiple gait phases was associated with less knee flexion displacement (r = −0.293 to −0.377), smaller peak vertical ground reaction force magnitude (r = −0.291), smaller peak internal knee extension moment (r = −0.291 to −0.328), and greater peak internal knee valgus moment (r = 0.317).InterpretationIndividuals with ACLR displayed heightened co-activation during walking which was associated with biomechanical outcomes that have been linked to negative changes in joint health following ACLR. These data suggest that excessive co-activation may contribute to the mechanical pathogenesis of post-traumatic osteoarthritis.ClinicalTrials.gov Identifier: NCT02605876.     

Agonist and antagonist activation at the ankle monitored along the swing phase in hemiparetic gait

BackgroundDescending command in hemiparesis is reduced to agonists and misdirected to antagonists. We monitored agonist and antagonist activation along the swing phase of gait, comparing paretic and non-paretic legs.MethodsForty-two adults with chronic hemiparesis underwent gait analysis with bilateral EMG from tibialis anterior, soleus and gastrocnemius medialis. We monitored ankle and knee positions, and coefficients of agonist activation in tibialis anterior and of antagonist activation in soleus and gastrocnemius medialis over the three thirds of swing phase. These coefficients were defined as the ratio of the root-mean-square EMG from one muscle over any period to the root-mean-square EMG from the same muscle over 100 ms of its maximal voluntary isometric contraction.FindingsAs against the non-paretic side, the paretic side showed lesser ankle dorsiflexion and knee flexion (P < 1.E⁻⁵), with higher coefficients of agonist activation in tibialis anterior (+100 ± 28%, P < 0.05), and of antagonist activation in soleus (+224 ± 41%, P < 0.05) and gastrocnemius medialis (+276 ± 49%, P < 0.05). On the paretic side, coefficient of agonist activation in tibialis anterior decreased from mid-swing on; coefficients of antagonist activation in soleus and gastrocnemius medialis increased and ankle dorsiflexion decreased in late swing (P < 0.05).InterpretationDuring the swing phase in hemiparesis, normalized tibialis anterior recruitment is higher on the paretic than on the non-paretic leg, failing to compensate for a marked increase in plantar flexor activation (cocontraction). The situation deteriorates along swing with a decrease in tibialis anterior recruitment in parallel with an increase in plantar flexor activation, both likely related to gastrocnemius stretch during knee re-extension.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT03119948     

Effects of milrinone on renal perfusion,filtration and oxygenation in patients with acute heart failure and low cardiac output early after cardiac surgery

PurposeEarly postoperative heart failure is common after cardiac surgery, and inotrope treatment may impact renal perfusion and oxygenation. We aimed to study the renal effects of the inodilator milrinone when used for the treatment of heart failure after weaning from cardiopulmonary bypass (CPB).Material and methodsIn 26 patients undergoing cardiac surgery with CPB, we used renal vein catheterization to prospectively measure renal blood flow (RBF), glomerular filtration rate (GFR), and renal oxygenation. Patients who developed acute heart failure and low cardiac output (cardiac index <2.1 L/min/m²) at 30 min after weaning from CPB (n = 7) were given milrinone, and the remaining patients (n = 19) served as controls. Additional measurements were made at 60 min after CPB.ResultsIn patients with acute postoperative heart failure, before receiving milrinone, renal blood flow was lower (−33%, p < .05) while renal oxygen extraction was higher (41%, p < .05) compared to the control group. Milrinone increased cardiac index (21%, p < .001), RBF (36%, p < .01) and renal oxygen delivery (35%, p < .01), with no significant change in GFR and oxygen consumption compared to the control group.ConclusionsIn patients with acute heart failure after weaning from CPB, the milrinone-induced increase in cardiac output was accompanied by improved renal oxygenation.Trial registrationClinicalTrials.gov; identifier NCT02405195, date of registration; March 27, 2015, and NCT02549066, date of registration; 9 September 2015.     

Cancer history and risk factors in healthy older people enrolling in the ASPREE clinical trial

BackgroundCancer is a leading cause of death globally. Given the elevated risk of cancer with age and an ageing population, it is important to understand the changing burden of cancer in older populations. The ASPirin in Reducing Events in the Elderly (ASPREE) study randomised healthy older individuals to 100 mg aspirin or placebo, with clinical outcomes and disability-free survival endpoints. Detailed baseline data provides a rare opportunity to explore cancer burden in a uniquely healthy older population.MethodsAt study enrolment (2010–2014), self-reported personal cancer history, cancer type and cancer risk factor data were sought from 19,114 participants (Australia, n = 16,703; U.S., n = 2411). Eligible participants were healthy, free of major diseases and expected to survive 5 years.ResultsNearly 20% of enrolling ASPREE participants reported a prior cancer diagnosis; 18% of women and 22% of men, with women diagnosed younger (16% vs 6% of diagnoses <50 years). Cancer prevalence increased with age. Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants. Cancer history prevalence was not associated with contemporary common risk factors nor previous aspirin use, but was associated with poor health ratings in men. Blood and breast cancer history were more common with past aspirin use.ConclusionsPersonal cancer history in healthy older ASPREE participants was as expected for the most common cancer types in the respective populations, but was not necessarily aligned with known risk factors. We attribute this to survivor bias, likely driven by entry criteria.Trial Registration: International Standard Randomised Controlled Trial Number Register (ISRCTN83772183) and clinicaltrials.gov (NCT01038583).     

Effect of whole-body vibration on obstacle clearance and stair negotiation time in chronic stroke patients; A randomized controlled trial

ObjectiveTo assess the effect of Whole-Body Vibration (WBV) and Routine Physiotherapy (RP) on obstacle crossing and stair negotiation time in chronic stroke patients.MethodsThe current study was randomized, parallel-group, assessor-blinded, clinical trial conducted in Physiotherapy Department of Lahore General Hospital, involving 64 patients with chronic stroke. Patients were randomly allocated to 2 groups, i.e., the WBV group (n = 32) and the RP group (n = 32). The WBV group was given additional twelve sessions of vibration therapy (amplitude of 3 mm and frequency of 20 Hz), 6 days/week for 2 weeks. The outcome measures were change in score of height and depth of obstacles cleared, i.e., 6, 8, 10 & 12 inches height and 6, 8, 10 & 12 inches depth and stair negotiation time, i.e., Stair-Climb Test. Chi square test, Independent sample t-test and Paired sample t-test were used to analyze the data.ResultsResults show that higher number of patients improved in crossing the maximum height and maximum depth of obstacles in the WBV group but improvement was significant only in height, i.e., (p < 0.05). In the WBV group, Stair Negotiation Time decreased significantly as compared to the RP group, i.e., (p < 0.05).ConclusionsThe present study concluded that both study groups, i.e., RP and WBV, improved despite better results for the latter. Speed of stair climbing and capacity to cross obstacles improved with the WBV therapy in chronic stroke survivors.Trial registrationIRCT, IRCT20190328043131N1. Registered 03 august 2019 - Retrospectively registered, https://www.irct.ir/user/trial/38832/view.     

Transversus abdominis activation does not alter gait impairments in patients with and without knee osteoarthritis

BackgroundKnee osteoarthritis accounts for more years of disability than all other forms of osteoarthritis combined. Gait kinetic and kinematic changes, in addition to reduced gait speed, are commonly observed. This study investigates whether core activation, which modifies lower extremity movement in young, active populations, can alter the gait and baseline core activation of those with knee osteoarthritis as compared to controls, and alter osteoarthritic knee pain.MethodsForty-four participants (22 controls and 22 with knee osteoarthritis) underwent biomechanical gait assessment, examining kinetic and kinematic variables, in addition to gait speed, with and without volitional transversus abdominis activation. Surface electromyography was used to measure baseline transversus abdominis activation under both conditions. Knee pain ratings were examined for those with knee osteoarthritis.FindingsNo significant biomechanical differences were observed within groups, or in the time/group interaction. Between-groups kinetic (time to first peak ground reaction force and amplitude of second peak ground reaction force) and gait speed differences were observed under both conditions. There were no differences in baseline electromyography activation between or within-groups, or within-group for self-reported pain for the osteoarthritic group.InterpretationAlthough previous studies have shown the benefit of core activation in correcting lower extremity movement patterns and kinetic loading in young, athletic populations, this study is the first to show this is not the case for persons with knee osteoarthritis. Future studies should examine the value of a progressive core stabilization program, of sufficient dose and mode, in correcting the observed gait differences in those with knee osteoarthritis.Clinical Trial Registration Number: NCT03776981     

The effect of self-affirmation on anxiety and perceived discomfort in patients who have undergone open-heart surgery. A randomized controlled trial

BackgroundSelf-affirmations help one focus on positive outcomes and adapt to new situations both psychologically and physiologically by the repetition of positive affirmation sentences. This method, which has promising results in symptom management, is predicted to have effective results in the management of pain and discomfort in patients undergoing open-heart surgery.AimTo investigate the effect of self-affirmation on anxiety and perceived discomfort in patients who have undergone open-heart surgery.MethodsThis study adopted a randomized controlled pretest-posttest follow-up research design. The study was conducted at a public training and research hospital (Istanbul, Turkey) specialized in thoracic and cardiovascular surgery. The sample consisted of 61 patients randomized into two groups: intervention (n = 34) and control (n = 27). The participants of the intervention group listened to a self-affirmation audio recording for three days after surgery. Anxiety levels and perceived discomfort regarding pain, dyspnoea, palpitations, fatigue and nausea were measured daily. The State Trait Anxiety Inventory (STAI) was used to measure the level of anxiety, meanwhile perceived discomfort regarding pain, dyspnoea, palpitations, fatigue and nausea were measured by a 0 to 10 Numeric Rating Scale (NRS).ResultsThe control group had significantly higher anxiety than the intervention group three days after surgery (P < 0.001). The intervention group had less pain (P < 0.01), dyspnoea (P < 0.01), palpitations (P < 0.01), fatigue (P < 0.001) and nausea (P < 0.01) than the control group.ConclusionsPositive self-affirmation helped reduce anxiety and perceived discomfort in patients who underwent open-heart surgery.ClinicalTrials.gov Identifier: NCT05487430.     

Noninvasive ventilation support during fiberoptic bronchoscopy-guided nasotracheal intubation effectively prevents severe hypoxemia

PurposeThis study investigated the feasibility and efficacy of continuous noninvasive ventilation (NIV) support with 100% oxygen using a specially designed face mask, for reducing desaturation during fiberoptic bronchoscopy (FOB)-guided intubation in critically ill patients with respiratory failure.Materials and methodsThis was a single-center prospective randomized study. All patients undergoing FOB-guided nasal tracheal intubation were randomized to bag-valve-mask ventilation or NIV for preoxygenation followed by intubation. The NIV group were intubated through a sealed hole in a specially designed face mask during continuous NIV support with 100% oxygen. Control patients were intubated with removal of the mask and no ventilatory support.ResultsWe enrolled 106 patients, including 53 in each group. Pulse oxygen saturation (SpO₂) after preoxygenation (99% (96%–100%) vs. 96% (90%–99%), p = .001) and minimum SpO₂ during intubation (95% (87%–100%) vs. 83% (74%–91%), p < .01) were both significantly higher in the NIV compared with the control group. Severe hypoxemic events (SpO₂ < 80%) occurred less frequently in the NIV group than in controls (7.4% vs. 37.7%, respectively; p < .01).ConclusionsContinuous NIV support during FOB-guided nasal intubation can prevent severe desaturation during intubation in critically ill patients with respiratory failure.Trial registration: ClinicalTrials.gov, NCT02462668. Registered on 25 May 2015, https://www.clinicaltrials.gov/ct2/results?term=NCT02462668.     

Influence of graft type on sagittal plane knee biomechanics during stair ambulation following anterior cruciate ligament reconstruction

BackgroundBoth graft type and surgical technique for anterior cruciate ligament reconstruction can affect knee biomechanics. Several studies reported the influence of graft type, but few have controlled the surgical technique and fully investigated stair ambulation. This study aimed to compare knee biomechanics during stair ambulation between patients treated with hamstring tendon graft and those treated with patellar tendon graft when anterior medial portal technique was used to drill femoral tunnel.MethodsTwo groups of patients (patellar tendon, n = 18; hamstring tendon, n = 18) at average 12 months after reconstruction surgery were recruited to ascend and descend a customized staircase in a gait lab. Joint kinematics and kinetics were calculated for both operated and contralateral intact limbs based on kinematic analysis and inverse dynamics. The influence of graft type on knee flexion angle and moment was identified using one-way mixed (graft type and limb side) analysis of variance with post-hoc paired t-test.FindingsSignificant interaction between graft and limb was found for knee flexion and range of motion. Only the hamstring tendon group had significant kinematic deficits on the operated limb than the contralateral limb during stair ascent and descent. No significant interaction was found for knee flexion moment. Both graft groups had significant deficits in peak knee flexion moment on the operated side during stair ascent and descent.InterpretationWhile the choice of graft type does not affect the restoration of knee dynamic loading, patellar tendon graft better restores knee flexion-extension kinematics during stair ambulation.     

A randomized controlled trial comparing non-invasive ventilation delivered using neurally adjusted ventilator assist (NAVA) or adaptive support ventilation (ASV) in patients with acute exacerbation of chronic obstructive pulmonary disease

PurposeNo study has compared neurally adjusted ventilator assist (NAVA) with adaptive support ventilation (ASV) during non-invasive ventilation (NIV) in subjects with acute exacerbation of chronic obstructive pulmonary disease (AECOPD).Materials and methodsIn this randomized controlled trial, we compared NAVA-NIV with ASV-NIV for delivering NIV in consecutive subjects with AECOPD. The primary outcome was NIV failure rate (invasive mechanical ventilation). The key secondary outcomes were number of NIV manipulations, asynchrony index, and 90-day mortality.ResultsWe enrolled 76 subjects (NAVA-NIV, n = 36, ASV-NIV, n = 40; 74% males) with a mean ± SD age of 61.4 ± 8.2 years. We found no difference in NIV failure rates between the two arms (NAVA-NIV vs. ASV-NIV; 8/36 [22.2%] vs. 8/40 [20%]; p = 0.83). The median physician manipulations for NIV were significantly less in the ASV-NIV arm than in the NAVA-NIV arm (2 [0.8–4] vs. 3 [2–5]; p= 0.014) during the initial 24-h. We found no difference in median asynchrony index (NAVA-NIV vs. ASV-NIV, 16.6% vs. 16.4%, p = 0.5) and 90-day mortality (22.2% vs. 17.5%, p = 0.67).ConclusionThe use of NAVA-NIV was not superior to ASV-NIV in reducing NIV failure rates in AECOPD. Both NAVA-NIV and ASV-NIV had similar asynchrony index and 90-day mortality.Trial registrywww.clinicaltrials.gov (NCT04414891).     

The effects of an enteral nutrition feeding protocol on critically ill patients: A prospective multi-center,before-after study

PurposeThe aim of this study was to explore the effects of an enteral nutrition (EN) feeding protocol in critically ill patients.MethodsThis was a prospective multi-center before-after study. We compared energy related and prognostic indicators between the control group (pre-implementation stage) and intervention group (post-implementation stage). The primary endpoint was the percentage of patients receiving EN within 7 days after ICU admission.Results209 patients in the control group and 230 patients in the intervention group were enrolled. The implementation of the EN protocol increased the percentage of target energy reached from day 3 to day 7, and the difference between two groups reached statistical significance in day 6 (P = .01) and day 7 (P = .002). But it had no effects on proportion of patient receiving EN (P = .65) and start time of EN (P = .90). The protocol application might be associated with better hospital survival (89.1% vs 82.8%, P = .055) and reduce the incidence of EN related adverse (P = .004). There was no difference in ICU length of stay, duration of mechanical ventilation and ICU cost.ConclusionThe implementation of the enteral feeding protocol is associated with improved energy intake and a decreased incidence of enteral nutrition related adverse events for critically ill patients, but it had no statistically beneficial effects on reducing the hospital mortality rate.Trial registrationClinicalTrials.gov, NCT02976155. Registered November 29, 2016- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02976155.     

Patients with total knee arthroplasty do not use all of their available range of knee flexion during functional activities

BackgroundRecent research designed to improve outcome from total knee arthroplasty has included focus on strategies that increase the range of post-operative knee flexion. Patients with knee arthroplasty can now expect > 100° of knee flexion following surgery, but it is not clear whether this improved range of motion facilitates outcome or whether patients take advantage of this range when completing daily functional activities. The aim of this study was to investigate the knee flexion angles used during daily functional activities that specifically required high degrees of knee flexion. It was hypothesised that patients with greater range of passive knee flexion would achieve higher degrees of knee flexion during functional activities.MethodsMotion analysis was used to assess the maximum knee flexion of 40 patients with total knee arthroplasty and 40 control participants as they performed maximum flexion squatting and lunging activities.FindingsPatients with knee arthroplasty used between 80.8 and 91.4° of knee flexion to complete these activities, which was 20 to 30% less than that used by the control participants. Patients with greater ranges of passive knee flexion had greater maximum knee flexion during functional activities. However, they used only between 68% and 77% of their full passive range when lunging and squatting.InterpretationThe development of rehabilitation strategies that aim to increase weightbearing knee flexion capacity may be warranted to improve functional performance following total knee arthroplasty.     

Safety,tolerability, pharmacokinetics,and efficacy of kukoamine B in patients with sepsis: A randomized phase IIa trial

PurposeTo evaluate the safety, tolerability, pharmacokinetics, and efficacy of kukoamine B (KB), an alkaloid compound with high affinity for both lipopolysaccharide (LPS) and oligodeoxynucle-otides containing CpG motifs (CpG DNA), in patients with sepsis-induced organ failure.Materials and methodsThis was a multicenter, randomized, double-blind, placebo-controlled phase IIa trial. Patients with sepsis-induced organ failure were randomized to receive either KB (0.06, 0.12, or 0.24 mg/kg) or placebo, every 8 h for 7 days. Primary endpoint was safety, and secondary endpoints included pharmacokinetic (PK) parameters, changes in inflammatory mediators' level, and prognostic parameters.ResultsOf 44 patients enrolled, adverse events occurred in 28 patients [n = 20, 66.7% (KB pooled); n = 8, 57.1% (placebo)], while treatment emergent adverse events were reported in 14 patients [n = 10, 33.3% (KB pooled); n = 4, 28.6% (placebo)]. Seven patients died at 28-day follow-up [n = 4, 13.3% (KB pooled); n = 3, 21.4% (placebo)], none was related to study drug. PK parameters suggested dose-dependent drug exposure and no drug accumulation. KB did not affect clinical outcomes such as ΔSOFA score, vasopressor-free days or ventilator-free days.ConclusionsIn patients with sepsis-induced organ failure, KB was safe and well tolerated. Further investigation is warranted.Trial registrationhttp://ClinicalTrials.gov, NCT03237728.     

The impact of a cardiopulmonary resuscitation video on reducing surrogates' anxiety: A pilot randomized controlled trial

PurposeTo test the primary hypothesis that a CPR video will reduce ICU patients' surrogates' anxiety when deciding code status, as measured by the Hamilton Anxiety Rating (HAM-A) Scale, as compared to the no video group.Materials and methodsThis is a prospective randomized control trial. Twenty-seven ICU patients' surrogates were enrolled in the study after receiving an ICU team-led code status discussion. After the enrollment, twelve surrogates were randomized to the video group and fifteen to the no video group. The primary outcome of anxiety was quantified using the HAM-A Scale. Demographic information, clinical data, and patients' provenance information (Home vs. Not Home) were collected. The patients' severity of illness was calculated using the Sequential Organ Failure Assessment (SOFA) Score.ResultsThe HAM-A score in the video group was 5.65 points lower than in the no video group ([β = −5.65, 95% CI −11.12 −0.18] P = 0.04). The statistically significant difference was maintained when adjusting for patients' SOFA Score and patients' provenance (P = 0.03).ConclusionCPR video used to supplement ICU team-led code status discussions reduced surrogates' anxiety, as compared to no video. Trial Registration: ClinicalTrials.gov Identifier NCT03630965.     

An adaptive clinical trial design for cocaine use disorder: Extended-release amphetamine salts for early behavioral intervention non-responders

Background/aimsCocaine use disorder (CUD) persists as a major public health problem in the United States. Response to evidence-based behavioral treatment has been shown to be predicted by dopaminergic dysfunction. Amphetamine formulations modulate dopaminergic systems and are one of the few agents with positive clinical findings but are associated with unique risks. We aimed to find a model for determining the most appropriate patients for treatment with mixed amphetamine salts-extended-release (MAS-ER) for CUD using an adaptive trial design.MethodsWe are enrolling treatment-seeking adults ages 18–60 years. All eligible participants receive bi-weekly individual counseling augmented with a computer-based intervention based on the community reinforcement approach with contingency management (CRA + CM) for 4 weeks. Participants who fail to achieve abstinence are additionally randomly assigned to 10 weeks of either MAS-ER, titrated up to 80 mg daily, or placebo. All participants complete a follow-up assessment after 12 weeks.ResultsFrequency and amount of cocaine use, cravings, retention, and quality of life will be compared between groups. The primary outcome will be having at least 3 weeks of urine toxicology-confirmed self-reported abstinence. Analyses will also be conducted to identify variables that may help identify who is more or less likely respond to the behavioral intervention during the first 4-weeks of treatment.ConclusionsThis trial more closely mimics a personalized medicine approach that is often used in clinical practice. It will help us understand who may be appropriate for psychostimulant therapy as an enhancement to evidence-based behavioral interventions, while limiting exposure to those who would respond to a psychosocial intervention alone.ClinicalTrials.gov Identifier: NCT01986075     

Comparative effectiveness of proprioceptive neuromuscular facilitation and passive vertebral mobilization for neck disability in patients with mechanical neck pain: A randomized controlled trial

ObjectiveTo compare the effectiveness of Proprioceptive Neuromuscular Facilitation (PNF) and Passive Vertebral Mobilization (PVM), both when given in adjunct to routine physical therapy (RPT), on neck disability in patients with mechanical neck pain (MNP).MethodsA single-blinded randomized controlled trial was conducted on 90 patients with MNP at the National Institute of Rehabilitation Medicine, Islamabad, Pakistan, from September 2015 to March 2018. The participants aged between 18 and 65 years were recruited through a simple random sampling technique and randomly divided into three groups i.e. PNF + RPT, PVM + RPT, and RPT. Each participant was evaluated pre and post-intervention (after four weeks) through neck disability index (NDI). The data were analyzed by using SPSS version 21.ResultsThe MANOVA was run on the pre-post mean differences of the variables to determine the changes within the groups which showed that the participants improved significantly in all the groups in terms of the NDI components and overall NDI score (p < 0.05). Univariate analysis with the post-hoc comparison and Tuckey HSD correction was used to determine the differences between the groups which showed that there was a significant difference between the interventional groups in the overall pain intensity, as well as pain experienced while performing personal care activities, reading, doing work, driving, sleeping, recreation and in the total NDI score (p < 0.05).ConclusionPVM (in adjunct to RPT) was more effective than PNF (in adjunct to RPT) for the patients with MNP to manage themselves in daily activities.Clinical trial registrationNCT03813680 (at clinicaltrials.gov) (https://clinicaltrials.gov/ct2/show/NCT03813680)     

Increased knee loading in stair ambulation in patients dissatisfied with their total knee replacement

BackgroundTotal knee replacement patients have shown reductions in knee flexion range of motion, knee extensor moments, and gait speed during stair ascent and stair descent. However, it is unknown how patients dissatisfied with their total knee replacement differ from those who are satisfied during more difficult activities such as stair negotiation. Therefore, the purpose of this study was to compare knee biomechanics of patients who are dissatisfied with their joint replacement to those who are satisfied and healthy participants during stair negotiation.MethodsNine dissatisfied, fifteen satisfied patients and fifteen healthy participants participated, completing stair ascent and descent trials on an instrumented staircase. A 2 × 3 ANOVA was used to analyze biomechanical differences between groups and limbs during both activities.FindingsThe dissatisfied group showed reduced 2nd peak vertical GRF (P ≤ 0.0040) and loading-response knee extension moments (P ≤ 0.0041) in their operated limb compared to their non-operated limb and to satisfied and healthy groups during stair ascent. First peak vertical GRF (P < 0.0088) and both loading-response (P < 0.0117) and push-off abduction moments (P < 0.0028) showed reduced values in operated limbs compared to non-operated limbs for all groups. During stair descent, the dissatisfied group showed reduced loading-response and push-off knee extension moments (P ≤ 0.006) in their operated limb compared to their non-operated limb and the healthy group. The loading-response knee extension (P < 0.0379) and abduction moments (P ≤ 0.0048) were also reduced in the dissatisfied group compared to the satisfied group.InterpretationPatients who were dissatisfied showed asymmetrical loading of the knees in conjunction, which may have contributed to their dissatisfaction.     

Diagnostic accuracy of arterial and venous renal Doppler assessment for acute kidney injury in critically ill patients: A prospective study

Background and purposeRenal Resistive Index (RRI) and Venous Impedance Index (VII) might be of additional value for diagnosing Acute Kidney Injury (AKI). The purpose of this study was to assess the diagnostic accuracy of RRI and VII for AKI.Materials and methodsIn the prospective Simple Intensive Care Studies-II (NCT03577405), we measured RRI and VII in acutely admitted adult intensive care patients within 24 h of admission. AKI was defined by the Kidney Disease Improving Global Outcome (KDIGO) criteria. The primary outcome was persistent AKI, defined as non-resolved AKI on day three. We tested specificity, sensitivity and diagnostic accuracy of both RRI and VII for persistent AKI.ResultsIn total, 371 patients were included of whom 123 patients (33%) had persistent AKI. RRI and VII did not differ between patients with and those without persistent AKI (p = .08 and p = .59). RRI had a moderate specificity (72%, 95%CI 66–78%) and low sensitivity (32%, 95%CI 24–41%) and VII had high sensitivity (93%, 95%CI 85–98%) and low specificity (11%, 95%CI 6–16%) for persistent AKI. Overall diagnostic accuracy of RRI and VII was moderate.ConclusionsIn acutely admitted critically ill patients, measures of renal perfusion by renal ultrasound were not different between patients with and without AKI, and show limited diagnostic accuracy for AKI.Registered: NCT03577405     

The impact of Geriatric Emergency Department Innovations (GEDI) on health services use,health related quality of life,and costs: Protocol for a randomized controlled trial

Background and objectivesOlder adults (age 65 and older) use the emergency department (ED) at a rate of nearly 50 ED visits per 100 older adults, accounting for over 23 million ED visits in the US annually, up to 20% of all ED visits. These ED visits are sentinel health events as discharged patients often return to the ED, experience declines in health-related quality of life (HRQoL) and disability, or are later hospitalized. Those who are admitted incur increased costs and greater risk for poor outcomes including infections, delirium, and falls. The objective of this randomized controlled trial (RCT) is to evaluate the efficacy of the Geriatric Emergency Department Innovations (GEDI) program, an ED nurse-led geriatric assessment and care coordination program, in decreasing unnecessary health services use and improving Health-Related Quality-of-Life (HRQoL) for older adults in the ED.MethodsCommunity dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420). Outcome variables will be assessed during the ED visit and at 7–11 days and 28–32 days post ED visit.Projected outcomesThe primary outcome is hospitalization or death within 30 days of the ED visit. Secondary outcomes include health service use outcomes (ED visits and hospitalizations), healthcare costs, and HRQoL outcomes [Patient-Reported Outcomes Measurement Information System (PROMIS) scores: PROMIS-Preference, Physical Function, Ability to Participate in Social Roles and Activities, Anxiety, and Depression].Trial registrationClinicaltrials.Gov identifier NCT04115371     

Time limited eating in adolescents with obesity (time LEAd): Study protocol

BackgroundTime limited eating (TLE) has been shown to be effective for weight loss and improvement of glycemic control in adults with obesity and type 2 diabetes (T2D), but has not been well studied in adolescents. TLE may be a more feasible, flexible and effective dietary intervention for adolescents because it removes the need for intensive counting of calories or macronutrients, and emphasizes eating during a specified time period.ObjectivesThe aim of this study is to assess the feasibility of a TLE approach in adolescents with obesity using a continuous glucose monitor (CGM) to promote adherence to the intervention.MethodsWe propose a prospective, randomized controlled trial, in 60 adolescents (ages 14–18) with obesity (BMI% ≥ 95th percentile). Youth will be randomized to one of three treatment groups for a 12-week intervention: Group 1) Low sugar and carbohydrate education (LSC, 5% of total daily calories from sugar (<35 g)/day; <90 g carbohydrate (CHO)/day) + blinded CGM (used to monitor adherence and glycemic outcomes without real time feedback), Group 2) LSC + TLE (16-h fast/8-h feed for 5 days per week) + blinded CGM, and Group 3) LSC + TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy). Outcomes will include change in total body fat (TBF) percentage measured on DEXA scan, BMI status and fasting blood glucose at 12 weeks compared to baseline.ConclusionsTLE is a potentially powerful lifestyle intervention that could be readily integrated into pediatric weight management programs to optimize their impact and accelerate healthy changes.Clinical trial registrationClinicalTrials.gov identifier: NCT03954223