Between-group Difference In Improvement Research Articles

Impact of prior knee surgery on change in knee pain, quality of life, and walking speed following supervised education and exercise therapy: an analysis of 30,545 people with knee osteoarthritis

To investigate the impact of prior knee surgery on changes in outcomes following an 8-week supervised patient education and exercise therapy program in patients with knee osteoarthritis. Patients were classified according to knee surgery in the most affected knee joint (yes/no) prior to enrolment in the Good Life with osteoArthritis in Denmark (GLA:D®) program. Between-group differences in outcome changes from baseline to 3 months follow-up were evaluated using linear regression stratified by sex. Outcomes were knee pain intensity (VAS, 0–100 mm), joint related quality of life (Knee Injury and Osteoarthritis Outcome Score Quality of Life subscale score (KOOS QOL, 0–100)) and walking speed (40-m fast-paced walk test). To evaluate clinically relevant between-group differences, proportions of patients reaching a threshold of minimal important change in the surgery and non-surgery groups were compared. Among 30,545 patients, 27% (n, 8254) had prior surgery in the most affected knee. The prior surgery and the non-surgery group experienced improvements in all outcomes with minor between-group differences in change in pain intensity (males, 0.03 95% CI − 0.9 to 1.0; females, 1.3 95% CI 0.6 to 2.1); KOOS QOL (males, 0.3 95% CI − 0.4 to 0.9; females 0.02 95% CI − 0.5 to 0.5); and walking speed (males, 0.01 95% CI − 0.01 to 0.02; females 0.01 95% CI 0.003 to 0.02). The responder analysis showed no clinically relevant between-group differences in improvements. Previous knee surgery does not seem to modify the clinical outcome following exercise therapy and patient education in patients with knee osteoarthritis.Key Points• About one in four patients with knee osteoarthritis participating in an 8-week supervised patient education and exercise therapy program had previous knee joint surgery in the most affected knee.• Those with prior knee surgery were more likely to be males, to have prior knee injury, to have a longer symptom duration, and to have a high physical activity level compared to those without previous knee surgery.• Patients with prior knee surgery did not experience clinically relevant less change in knee pain, joint related quality of life, and walking speed after participation in the intervention, compared to those without previous knee surgery.• Patients with previous knee surgery can expect clinical outcomes following exercise therapy and patient education similar to patients without prior knee joint surgery.

Total Knee Arthroplasty Versus Education and Exercise for Knee Osteoarthritis: A Propensity-Matched Analysis.

We estimate the treatment effect of total knee arthroplasty (TKA) versus an education and exercise (Edu+Ex) program on pain, function, and quality of life outcomes 3 and 12 months after treatment initiation for knee osteoarthritis (OA). Patients with knee OA who had undergone TKA were matched on a 1:1 ratio with participants in an Edu+Ex program based on a propensity score fitted to a range of pretreatment covariates. After matching, between-group differences in improvement (the treatment effect) in Knee Injury and Osteoarthritis Outcome Score 12-item version (0, worst to 100, best) pain, function, and quality of life from baseline to 3 and 12 months were estimated using linear mixed models, adjusting for unbalanced covariates, if any, after matching. The matched sample consisted of 522 patients (Edu+Ex, n=261; TKA, n=261) who were balanced on all pretreatment characteristics. At 12-month follow-up, TKA resulted in significantly greater improvements in pain (mean difference [MD] 22.8; 95% confidence interval [95% CI] 19.7-25.8), function (MD 21.2; 95% CI 17.7-24.4), and quality of life (MD 18.3; 15.0-21.6). Even so, at least one-third of patients receiving Edu+Ex had a clinically meaningful improvement in outcomes at 12 months compared with 75% of patients with TKA. TKA is associated with greater improvements in pain, function, and quality of life, but these findings also suggest that Edu+Ex may be a viable alternative to TKA in a meaningful proportion of patients, which may reduce overall TKA need. Confirmatory trials are needed.

Abstract 14315: Does Gender Moderate the Effect of Virtual Cognitive Behavioral Therapy Interventions on Depressive Symptoms in Rural Cardiac Patients? Preliminary Analysis of the Combat Study

Background: Depressive symptoms are common in patients with coronary heart disease (CHD) and heart failure (HF) living in rural areas and are associated with worse health outcomes. Cognitive behavioral therapy (CBT) can effectively improve depressive symptoms in patients with CHD and HF, however, traditional CBT is not accessible to most rural individuals, and some, particularly males, may be reluctant to participate in traditional CBT even if available. Therefore, we developed and tested two types of virtual CBT, video conferences with a therapist (vCBT) and self-directed CBT (iCBT). Aim: To determine whether gender moderated the effect of vcCBT or iCBT interventions on depressive symptoms in rural people with CHD and HF. Methods: This is a preliminary analysis of 4-month outcomes in an ongoing 12-month randomized comparative effectiveness trial. Depressive symptoms were measured by the Patient Health Questionnaire-9 (PHQ-9). Gender was self-identified. Participants with at least mild depressive symptoms were enrolled. Participants were randomly assigned to either a 6-8 week vcCBT or iCBT without a face-to-face therapist. Repeated measures ANOVA was performed to determine whether gender interacted with either intervention to produce an effect on depressive symptoms at 4-months compared with baseline. Results: Participants (N=143) were on average 57 years old, 51% female, and 99.3 % non-Hispanic. At baseline, mean PHQ-9 score for males was 10 ± 5 and 12 ± 5 for females (p-value=0.002). Both intervention groups had a significant decrease in depressive symptoms over time (p<0.001 for group by time interaction). There was no between-group difference in improvement of depressive symptoms (p=0.415). There was no moderating interaction of gender by intervention group on depressive symptoms (p=0.502). Conclusion: Both interventions resulted in a significant decrease in depressive symptoms. The lack of a gender moderating effect demonstrates that both interventions were equally effective in males and females.

No Difference Between One-shot Co-injection of Corticosteroids and Hyaluronic Acid in a Three-injection Regimen for Knee Osteoarthritis: A Randomized, Double-blind Trial [RETRACTED

Although many guidelines now recommend against hyaluronic acid (HA) injections alone for the nonoperative management of knee osteoarthritis (OA), prior studies have disagreed about whether adding an intra-articular corticosteroid to HA results in sufficient benefit to justify the potential dose-dependent and time-dependent chondrotoxicity of corticosteroids. (1) Do patients with knee OA treated with low-dose intra-articular corticosteroids and HA administered under ultrasound guidance have more favorable patient-reported knee OA-related outcomes from 1 to 26 weeks after treatment than those treated with ultrasound-guided HA injections alone? (2) Do patients treated with a corticosteroid co-injection exhibit more favorable physical functional performance than those treated with injections of HA alone? We conducted a randomized, double-blind trial at a small medical center in urban Taipei, Taiwan. We considered those who fulfilled the clinical and radiographic criteria for knee OA, defined by the American College of Rheumatology as a Kellgren-Lawrence grade 2 or 3, as potentially eligible. We excluded those who had a previous knee fracture or surgery and those who had received intra-articular knee injections of HA or corticosteroids within 6 months of the trial. Based on these criteria, 78 patients were eligible, and 76 agreed to be randomized to the co-injection or HA-only groups through block randomization. The groups had 38 patients each; all participants who completed the study follow-up were analyzed in the groups to which they were randomized and treated. There was no crossover. The patients in the co-injection group were treated with a one-shot co-injection of HA with corticosteroids (Hyruan Plus: molecular weight, 3000 kDa, 10 mg/mL HA, 2 mL with triamcinolone acetonide 10 mg/dL, 1 mL) in the first week followed by two injections of HA (10 mg/mL, 2 mL) at a 1-week interval. The patients in the HA-only group received three HA injections (Hyruan Plus: molecular weight, 3000 kDa, 10 mg/mL HA, 2 mL) administered at a 1-week interval. A senior physiatrist performed ultrasound-guided knee injections using the lateral suprapatellar approach. The physiatrist, participants, and outcome assessor were all blinded to the injection contents. No differences were observed between the two groups regarding primary demographic data, baseline WOMAC and Knee Injury and Osteoarthritis Outcome Score (KOOS) scores, and physical functional performance. Three participants experienced localized swelling after the injections, and all symptoms improved after a few days of localized ice pack application. A total of 3.9% of patients (three of 76) had adverse events (mainly localized swelling of the knee, with or without accompanying pain), with no between-group differences in the frequency of adverse events. No severe side effects were reported during or after the injections. The patient-reported outcomes were the WOMAC and KOOS scores. The objective outcome was physical function performance (speed for 10-meter regular and fastest walking, and time for stair-climbing and chair-rising). The primary outcome timepoint was 6 months postinjection. A sample size of 34 participants was required in each group, based on a difference in WOMAC scores of 58 points, a significance level of 0.05, and a power of 0.8. We found no difference in improvement from baseline between the two groups regarding patient-reported outcomes at any follow-up timepoint, from 1 week after injection to 6 months. At 6 months post-treatment, compared with baseline, there were no between-group differences in improvement between the co-injection group and the HA-only group in terms of WOMAC pain scores (mean difference 1 [95% CI -2 to 3]; p = 0.62), stiffness (mean difference -11 [95% CI -13 to -9]; p < 0.001), and physical function (mean difference -4 [95% CI -5 to -3]; p < 0.001) and KOOS scores for pain, other symptoms, activities of daily living, sports and recreation, and quality of life. Except for chair-rising time at 6 months, which may have represented spurious significance because of the number of comparisons, compared with baseline, we found no differences in improvement between the two groups regarding the regular and fastest walking speed and stair ascent and descent time. We found that a single co-injection of corticosteroids along with HA did not confer any additional benefit regarding patient-reported outcomes or physical function compared with a three-injection regimen of HA. Therefore, we do not recommend a one-shot co-injection of corticosteroids alongside the three-injection regimen of HA for patients with knee OA, and because prior research found HA to be ineffective, HA should not be used with or without corticosteroids for patients with knee OA. Level I, therapeutic study.

Efficacy and safety of low-dose sacubitril/valsartan in heart failure patients: A systematic review and meta-analysis.

Controversy has persisted over the clinical benefits of low-dose sacubitril/valsartan in patients with heart failure (HF). Low-dose sacubitril/valsartan might also be effective and safe in HF patients. Electronic databases including PubMed, Ovid, and Cochrane Library were systematically retrieved from inception to August 5, 2021. Review manager 5.4 and Stata 15.1 were employed in this systematic review and meta-analysis. Key efficacy outcomes of interest included HF hospitalization, all-cause mortality, left ventricular ejection fraction (LVEF), N-terminal pro-B-type natriuretic peptide (NT-proBNP), together with New York Heart Association (NYHA) functional class. The safety outcome was systolic blood pressure (SBP). The grading of recommendations assessment, development, and evaluationapproach was conducted to evaluate the quality of evidence for each outcome. A total of 1269 studies were screened and 9 real-world studies met the inclusion criteria were included in the meta-analysis, with 1697 participants. Compared with low-dose sacubitril/valsartan, high-dose sacubitril/valsartan significantly reduced the risk of HF hospitalization (odds ratio[OR]: 0.4, 95%confidence interval[CI]: 0.27-0.61, p < .0001) and the risk of all-cause mortality (OR: 0.23, 95%CI: 0.11-0.47, p < .0001). However, there were no appreciable differences in improvements of NYHA (OR: 0.59, 95%CI: 0.15-2.35, p = .45), changes of LVEF (mean difference[MD]: 2.73%, 95%CI: -2.24% to 7.7%, p = .28), changes of NT-proBNP (MD: 43.09, 95%CI: -28.41 to 114.59, p = .24) and changes of SBP (MD: 3.01, 95%CI: -4.62 to 10.64, p = .44) between groups with low-dose and high-dose sacubitril/valsartan. Compared with high-dose sacubitril/valsartan, low-dose sacubitril/valsartan was associated with increased risks of HF hospitalization and all-cause mortality. However, no distinct between-group differences in improvements of NYHA, changes of LVEF, changes of NT-proBNP and changes of SBP were observed.

Self-reported Reasons for Changes in Performance of Daily Activities During a 2-Year Multidisciplinary Multiple Sclerosis Rehabilitation.

Few multidisciplinary rehabilitation studies with a heterogeneous design have focused on individuals with multiple sclerosis (MS). This study compared subjective-reported changes in performance and satisfaction with daily activities among moderately and severely disabled individuals with MS during a 2-year, multidisciplinary, group-based, outpatient rehabilitation program comprising education in self-management and compensatory techniques, exercise, and guided peer support. Thirty-eight adults with moderate disability (Expanded Disability Status Scale [EDSS] score of 4.0-5.5, 74% women, mean age of 48) and 41 individuals with severe disability (EDSS 6.0-8.5, 63% women, mean age of 48) were assessed at baseline and after 12 and 21 months of outpatient rehabilitation using the Canadian Occupational Performance Measure (COPM). Group × time interactions were analyzed using mixed analysis of variance. Participants' explanations of reasons for changes in activity performance were collected via semistructured interviews and analyzed content. Statistically significant improvements in COPM performance and satisfaction scores were reported in both groups from baseline to 21 months of rehabilitation. No significant between-group differences in improvement were observed. The self-reported reasons for improvement were mainly linked to environmental factors. The outpatient rehabilitation program, including 4 themes-cognition, mood, energy conservation, and body control-improved the self-reported performance of patients with MS with moderate and severe disabilities. Environmental factors warrant consideration during rehabilitation.

Surgical Plating vs Closed Reduction for Fractures in the Distal Radius in Older Patients

The burden of injury and costs of wrist fractures are substantial. Surgical treatment became popular without strong supporting evidence. To assess whether current surgical treatment for displaced distal radius fractures provided better patient-reported wrist pain and function than nonsurgical treatment in patients 60 years and older. In this multicenter randomized clinical trial and parallel observational study, 300 eligible patients were screened from 19 centers in Australia and New Zealand from December 1, 2016, until December 31, 2018. A total of 166 participants were randomized to surgical or nonsurgical treatment and followed up at 3 and 12 months by blinded assessors. Those 134 individuals who declined randomization were included in a parallel observational cohort with the same treatment options and follow-up. The primary analysis was intention to treat; sensitivity analyses included as-treated and per-protocol analyses. Surgical treatment was open reduction and internal fixation using a volar-locking plate (VLP). Nonsurgical treatment was closed reduction and cast immobilization (CR). The primary outcome was the Patient-Rated Wrist Evaluation score at 12 months. Secondary outcomes were Disabilities of Arm, Shoulder, and Hand questionnaire score, health-related quality of life, pain, major complications, patient-reported treatment success, bother with appearance, and therapy use. In the 300 study participants (mean [SD] age, 71.2 [7.5] years; 269 [90%] female; 166 [81 VLP and 85 CR] in the randomized clinical trial sample and 134 [32 VLP and 102 CR] in the observational sample), no clinically important between-group difference in 12-month Patient-Rated Wrist Evaluation scores (mean [SD] score of 19.8 [21.1] for VLP and 21.5 [24.3] for CR; mean difference, 1.7 points; 95% CI -5.4 to 8.8) was observed. No clinically important differences were found in quality of life, wrist pain, or bother at 3 and 12 months. No significant difference was found in total complications between groups (12 of 84 [14%] for the CR group vs 6 of 80 [8%] for the VLP group; risk ratio [RR], 0.53; 95% CI, 0.21-1.33). Patient-reported treatment success favored the VLP group at 12 months (very successful or successful: 70 [89%] vs 57 [70%]; RR, 1.26; 95% CI, 1.07-1.48; P = .005). There was greater use of postoperative physical therapy in the VLP group (56 [72%] vs 44 [54%]; RR, 1.32; 95% CI, 1.04-1.69; P = 0.02). This randomized clinical trial found no between-group differences in improvement in wrist pain or function at 12 months from VLP fixation over CR for displaced distal radius fractures in older people. http://anzctr.org.au identifier: ACTRN12616000969460.

A positive psychology-motivational interviewing program to promote physical activity in type 2 diabetes: The BEHOLD-16 pilot randomized trial

BackgroundThe majority of persons with type 2 diabetes (T2D) do not meet recommended levels of physical activity, despite clear links between physical activity and superior medical outcomes in this population. The objective of this trial was to assess the feasibility and impact of a novel 16-week combined positive psychology-motivational interviewing (PP-MI) program to promote physical activity among inactive persons with T2D. MethodsThis pilot randomized trial compared the 16-week, phone-delivered PP-MI intervention to an attention-matched diabetes counseling condition among 70 persons with T2D and low levels of baseline moderate to vigorous physical activity (MVPA; <150 min/week). The primary study outcomes were feasibility (assessed via rates of session completion) and acceptability (assessed via mean participant ratings [0−10] of the ease and utility of weekly sessions). Key secondary outcomes included between-group differences in improvement in positive affect, other psychological outcomes, and accelerometer-measured physical activity, assessed using mixed effects regression models, at 16 and 24 weeks. ResultsParticipants completed a mean 11.0 (SD 4.4; 79%) of 14 PP-MI phone sessions, and composite mean ratings of ease/utility were 8.6/10, above our a priori benchmarks for feasibility/acceptability (70% session completion; 7.0/10 mean ratings). PP-MI participants had small to medium effect size (ES) difference improvements in MVPA (ES difference = 0.34) and steps/day (ES difference = 0.76) at 16 weeks, with sustained but smaller effects at 24 weeks (ES difference = 0.22–0.33). ConclusionsNext-step studies of this PP-MI program in T2D patients can more rigorously explore the intervention's effects on physical activity and clinical outcomes.

Oral neuromuscular training in patients with dysphagia after stroke: a prospective, randomized, open-label study with blinded evaluators

BackgroundOral and pharyngeal swallowing dysfunction are common complications in acute stroke patients. This primary aim of this study was to determine whether oral neuromuscular training improves swallowing function in participants with swallowing dysfunction after stroke. A secondary aim was to assess how well results of the timed water-swallow test (TWST) correspond with swallowing dysfunction diagnosed by videofluoroscopy (VFS).MethodsThis was an intention-to-treat two-centre prospective randomized open-label study with blinded-evaluators (PROBE) design. At 4 weeks after stroke onset, participants with swallowing dysfunction were randomized to 5 weeks of continued orofacial sensory-vibration stimulation with an electric toothbrush or additional oral neuromuscular training with an oral device (Muppy®). Participants were examined with TWST, a lip-force test, and VFS before (baseline), after 5 weeks’ treatment (the end-of-treatment), and 12 months after treatment (follow-up). The baseline VFS results were compared with the TWST results. The primary endpoint was changes in swallowing rate assessed using TWST, from baseline to the end of training and from baseline to follow-up based on intention-to-treat analyses. The secondary endpoint was the corresponding changes in lip-force between baseline, the end of treatment, and follow-up.ResultsThe participants were randomly assigned as controls (n = 20) or for intervention with oral neuromuscular training (n = 20). After treatment, both groups had improved significantly (intervention, P < 0.001; controls, P = 0.001) in TWST but there was no significant between-group difference in swallowing rate. At the 12-month follow-up, the intervention group had improved further whereas the controls had deteriorated, and there were significant between-group differences in swallowing rate (P = 0.032) and lip force (P = 0.001). A TWST < 10 mL/sec at baseline corresponded to VFS-verified swallowing dysfunction in all assessed participants.ConclusionThe 5-week oral neuromuscular training improved swallowing function in participants with post-stroke dysphagia compared with the controls 12 months after intervention, but there was no between-group difference in improvement immediately after treatment. TWST results corresponded with VFS results, making TWST a feasible method for identifying persons with swallowing dysfunction after stroke. Larger randomized controlled trials are required to confirm our preliminary positive long-term results.Trial registrationRetrospectively registered at ClinicalTrials.gov: NCT04164420. Registered on 15 November 2019.

Effect of a Collaborative Care Model on Depressive Symptoms and Glycated Hemoglobin, Blood Pressure, and Serum Cholesterol Among Patients With Depression and Diabetes in India

Mental health comorbidities are increasing worldwide and worsen outcomes for people with diabetes, especially when care is fragmented. To assess whether collaborative care vs usual care lowers depressive symptoms and improves cardiometabolic indices among adults with diabetes and depression. Parallel, open-label, pragmatic randomized clinical trial conducted at 4 socioeconomically diverse clinics in India that recruited patients with type 2 diabetes; a Patient Health Questionnaire-9 score of at least 10 (range, 0-27); and hemoglobin A1c (HbA1c) of at least 8%, systolic blood pressure (SBP) of at least 140 mm Hg, or low-density lipoprotein (LDL) cholesterol of at least 130 mg/dL. The first patient was enrolled on March 9, 2015, and the last was enrolled on May 31, 2016; the final follow-up visit was July 14, 2018. Patients randomized to the intervention group (n = 196) received 12 months of self-management support from nonphysician care coordinators, decision support electronic health records facilitating physician treatment adjustments, and specialist case reviews; they were followed up for an additional 12 months without intervention. Patients in the control group (n = 208) received usual care over 24 months. The primary outcome was the between-group difference in the percentage of patients at 24 months who had at least a 50% reduction in Symptom Checklist Depression Scale (SCL-20) scores (range, 0-4; higher scores indicate worse symptoms) and a reduction of at least 0.5 percentage points in HbA1c, 5 mm Hg in SBP, or 10 mg/dL in LDL cholesterol. Prespecified secondary outcomes were percentage of patients at 12 and 24 months who met treatment targets (HbA1c <7.0%, SBP <130 mm Hg, LDL cholesterol <100 mg/dL [<70 mg/dL if prior cardiovascular disease]) or had improvements in individual outcomes (≥50% reduction in SCL-20 score, ≥0.5-percentage point reduction in HbA1c, ≥5-mm Hg reduction in SBP, ≥10-mg/dL reduction in LDL cholesterol); percentage of patients who met all HbA1c, SBP, and LDL cholesterol targets; and mean reductions in SCL-20 score, Patient Health Questionnaire-9 score, HbA1c, SBP, and LDL cholesterol. Among 404 patients randomized (mean [SD] age, 53 [8.6] years; 165 [40.8%] men), 378 (93.5%) completed the trial. A significantly greater percentage of patients in the intervention group vs the usual care group met the primary outcome (71.6% vs 57.4%; risk difference, 16.9% [95% CI, 8.5%-25.2%]). Of 16 prespecified secondary outcomes, there were no statistically significant between-group differences in improvements in 10 outcomes at 12 months and in 13 outcomes at 24 months. Serious adverse events in the intervention and usual care groups included cardiovascular events or hospitalizations (4 [2.0%] vs 7 [3.4%]), stroke (0 vs 3 [1.4%]), death (2 [1.0%] vs 7 [3.4%]), and severe hypoglycemia (8 [4.1%] vs 0). Among patients with diabetes and depression in India, a 12-month collaborative care intervention, compared with usual care, resulted in statistically significant improvements in a composite measure of depressive symptoms and cardiometabolic indices at 24 months. Further research is needed to understand the generalizability of the findings to other low- and middle-income health care settings. ClinicalTrials.gov Identifier: NCT02022111.

WHEN AND HOW I WANT: FEASIBILITY AND EFFECTS OF EMBEDDING PHYSICAL ACTIVITY INTO NURSING HOME CARE

Physical activity (PA) is essential to maintaining health into older age. However, older adults living in nursing homes (NHs) remain highly inactive. This study tested the feasibility of a PA programme embedded into NH care and its potential effects on older adults’ function and quality of life (QOL). A cluster-randomised controlled pilot feasibility study, including qualitative and economic components, was conducted. Intervention participants (n=18) performed Morning Movement (morning-time walking and sit-to-stand exercises) and Activity Bursts (bouts of activity throughout the day in standing), 3 times weekly for 12-weeks. Participants in the control NH (n=16) received usual care. At baseline and 12-weeks, feasibility and economic data were collected, function was measured using the Timed Up and Go (TUG) and 10-Metre Walk Test (10MWT) and QOL was measured with the Nottingham Health Profile (NHP) and Investigating Choice Experiments for the Preferences of Older People-CAPability (ICECAP-O). Semi-structured interviews were conducted with staff and participants at mid- and post-intervention and analysed thematically. The PA programme was acceptable to staff and participants and study procedures were feasible. Mean TUG improved by 10.2 (±21.6) seconds in the intervention group and was unchanged -0.2 (9.5) seconds in the control group (95% confidence interval of between-group difference in improvement -2.5 to 23.3 seconds). 10MWT scores stayed stable in the intervention group and disimproved in the control group. ICECAP-O and NHP scores were unchanged. While this study contained a small sample, it demonstrated a feasible, acceptable and potentially effective NH PA intervention and provides guidance for a definitive trial.

Effectiveness of a Personalized Brain-Computer Interface System for Cognitive Training in Healthy Elderly: A Randomized Controlled Trial.

Cognitive training has been demonstrated to improve cognitive performance in older adults. To date, no study has explored personalized training that targets the brain activity of each individual. This is the first large-scale trial that examines the usefulness of personalized neurofeedback cognitive training. We conducted a randomized-controlled trial with participants who were 60-80 years old, with Clinical Dementia Rating (CDR) score of 0-0.5, Mini-Mental State Examination (MMSE) score of 24 and above, and with no neuropsychiatric diagnosis. Participants were randomly assigned to the Intervention or Waitlist-Control group. The training system, BRAINMEM, has attention, working memory, and delayed recall game components. The intervention schedule comprised 24 sessions over eight weeks and three monthly booster sessions. The primary outcome was the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score after the 24-session training. There were no significant between-subjects differences in overall cognitive performance post-intervention. However, a sex moderation effect (p = 0.014) was present. Men in the intervention group performed better than those in the waitlist group (mean difference, +4.03 (95% CI 0.1 to 8.0), p = 0.046. Among females, however, both waitlist-control and intervention participants improved from baseline, although the between-group difference in improvement did not reach significance. BRAINMEM also received positive appraisal and intervention adherence from the participants. A personalized neurofeedback intervention is potentially feasible for use in cognitive training for older males. The sex moderation effect warrants further investigation and highlights the importance of taking sex into account during cognitive training.

The Effect of Anti-Gravity Treadmill on Balance in Acute Phase of Post-Operative Knee Rehabilitation

Background: An anti-gravity treadmill has been used in orthopedic and neurological rehabilitation. However, little literature on its use in post-operative knee rehabilitation is available. Objectives: The purpose of this investigation was to study an effect of anti-gravity treadmill on balance in an early phase of post-operative knee rehabilitation. Methods: Forty-nine patients who underwent knee surgery participated in this study (study design: cohort study; level of evidence: level II). At one week post-operatively, each patient was tested for timed single leg stance (SLS) on surgical knee on a floor. Patients were placed onto either AlterG group (AG) or control group (CG) after the test based on their pain level. The patients in AG underwent a balance exercise on AlterG, with the pressure adjusted to a pain-free or minimal pain level, once a day at least 5 days a week. Those in CG underwent their balance exercise on a floor in the same manner. All patients were tested again for SLS at 2 week post-operatively. The lengths of SLS were recorded and analyzed. Results: The lengths of SLS were 38.8 seconds and 19.9 seconds for CG and AG, respectively, at 1 week post-operatively. They improved to 50.5 seconds (CG) and 35.0 seconds (AG) at 2 week post-operatively. There was statistically significant between-group difference at both 1 week and 2 week post-operatively. However, there was no significant between-group difference in improvement from week 1 to week 2. Conclusions: A use of anti-gravity treadmill may have a positive effect on balance in an acute phase of post-operative knee recovery in patients who had an increased level of pain during full weight-bearing immediately after knee operation.

Effect of Oral Capsule– vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection

Fecal microbiota transplantation (FMT) is effective in preventing recurrent Clostridium difficile infection (RCDI). However, it is not known whether clinical efficacy differs by route of delivery. To determine whether FMT by oral capsule is noninferior to colonoscopy delivery in efficacy. Noninferiority, unblinded, randomized trial conducted in 3 academic centers in Alberta, Canada. A total of 116 adult patients with RCDI were enrolled between October 2014 and September 2016, with follow-up to December 2016. The noninferiority margin was 15%. Participants were randomly assigned to FMT by capsule or by colonoscopy at a 1:1 ratio. The primary outcome was the proportion of patients without RCDI 12 weeks after FMT. Secondary outcomes included (1) serious and minor adverse events, (2) changes in quality of life by the 36-Item Short Form Survey on a scale of 0 (worst possible quality of life) to 100 (best quality of life), and (3) patient perception on a scale of 1 (not at all unpleasant) to 10 (extremely unpleasant) and satisfaction on a scale of 1 (best) to 10 (worst). Among 116 patients randomized (mean [SD] age, 58 [19] years; 79 women [68%]), 105 (91%) completed the trial, with 57 patients randomized to the capsule group and 59 to the colonoscopy group. In per-protocol analysis, prevention of RCDI after a single treatment was achieved in 96.2% in both the capsule group (51/53) and the colonoscopy group (50/52) (difference, 0%; 1-sided 95% CI, -6.1% to infinity; P < .001), meeting the criterion for noninferiority. One patient in each group died of underlying cardiopulmonary illness unrelated to FMT. Rates of minor adverse events were 5.4% for the capsule group vs 12.5% for the colonoscopy group. There was no significant between-group difference in improvement in quality of life. A significantly greater proportion of participants receiving capsules rated their experience as "not at all unpleasant" (66% vs 44%; difference, 22% [95% CI, 3%-40%]; P = .01). Among adults with RCDI, FMT via oral capsules was not inferior to delivery by colonoscopy for preventing recurrent infection over 12 weeks. Treatment with oral capsules may be an effective approach to treating RCDI. clinicaltrials.gov Identifier: NCT02254811.

Randomized controlled trial of increasing physical activity on objectively measured and self-reported cognitive functioning among breast cancer survivors: The memory & motion study.

Increasing physical activity can improve cognition in healthy and cognitively impaired adults; however, the benefits for cancer survivors are unknown. The current study examined a 12-week physical activity intervention, compared with a control condition, on objective and self-reported cognition among breast cancer survivors. Sedentary breast cancer survivors were randomized to an exercise arm (n = 43) or a control arm (n = 44). At baseline and at 12 weeks, objective cognition was measured with the National Institutes of Health Cognitive Toolbox, and self-reported cognition using the Patient-Reported Outcomes Measurement Information System scales. Linear mixed-effects regression models tested intervention effects for changes in cognition scores. On average, participants (n = 87) were aged 57 years (standard deviation, 10.4 years) and were 2.5 years (standard deviation, 1.3 years) post surgery. Scores on the Oral Symbol Digit subscale (a measure of processing speed) evidenced differential improvement in the exercise arm versus the control arm (b = 2.01; P < .05). The between-group differences in improvement on self-reported cognition were not statistically significant but were suggestive of potential group differences. Time since surgery moderated the correlation, and participants who were ≤2 years post surgery had a significantly greater improvement in Oral Symbol Digit score (exercise vs control (b = 4.00; P < .01), but no significant improvement was observed in patients who were >2 years postsurgery (b = -1.19; P = .40). A significant dose response was observed with greater increased physical activity associated with objective and self-reported cognition in the exercise arm. The exercise intervention significantly improved processing speed, but only among those who had been diagnosed with breast cancer within the past 2 years. Slowed processing speed can have substantial implications for independent functioning, supporting the potential importance of early implementation of an exercise intervention among patients with breast cancer. Cancer 2018;124:192-202. © 2017 American Cancer Society.

Virtual Reality Telerehabilitation for Postural Instability in Parkinson's Disease: A Multicenter, Single-Blind, Randomized, Controlled Trial.

Introduction Telerehabilitation enables patients to access remote rehabilitation services for patient-physiotherapist videoconferencing in their own homes. Home-based virtual reality (VR) balance training has been shown to reduce postural instability in patients with Parkinson's disease (PD). The primary aim was to compare improvements in postural stability after remotely supervised in-home VR balance training and in-clinic sensory integration balance training (SIBT). Methods In this multicenter study, 76 PD patients (modified Hoehn and Yahr stages 2.5–3) were randomly assigned to receive either in-home VR telerehabilitation (n = 38) or in-clinic SIBT (n = 38) in 21 sessions of 50 minutes each, 3 days/week for 7 consecutive weeks. VR telerehabilitation consisted of graded exergames using the Nintendo Wii Fit system; SIBT included exercises to improve postural stability. Patients were evaluated before treatment, after treatment, and at 1-month follow-up. Results Analysis revealed significant between-group differences in improvement on the Berg Balance Scale for the VR telerehabilitation group (p = 0.04) and significant Time × Group interactions in the Dynamic Gait Index (p = 0.04) for the in-clinic group. Both groups showed differences in all outcome measures over time, except for fall frequency. Cost comparison yielded between-group differences in treatment and equipment costs. Conclusions VR is a feasible alternative to in-clinic SIBT for reducing postural instability in PD patients having a caregiver.

High- and low-intensity exercise do not improve cognitive function after stroke: A randomized controlled trial.

To determine the effects of high versus low-intensity exercise on cognitive function following stroke. Secondary analysis from a randomized controlled trial with blinded assessors. 50-80 years old, living in the community, > 1 year post-stroke. Participants were randomized into a high-intensity Aerobic Exercise or low-intensity non-aerobic Balance/Flexibility program. Both programs were 6 months long, with 3 60-min sessions/week. Verbal item and working memory, selective attention and conflict resolution, set shifting were assessed before and after the program. Forty-seven participants completed the study (22/25 in Aerobic Exercise group, 25/25 in Balance/Flexibility group). There was an improvement in verbal item memory in both groups (time effect p = 0.04), and no between-group differences in improvement in the other outcomes (p > 0.27). There was no association between pre-exercise cognitive function and post-exercise improvement. In contrast to a small body of previous research suggesting positive benefits of exercise on cognition post-stroke, the current study found that 6 months of high or low intensity exercise was not effective in improving cognitive function, specifically executive functions. Further research in this area is warranted to establish the effectiveness of post-stroke exercise programs on cognition, and examine the mechanisms that underlie these changes.

A Combined Patient and Provider Intervention for Management of Osteoarthritis in Veterans: A Randomized Clinical Trial.

Management of osteoarthritis requires both medical and behavioral strategies, but some recommended therapies are underused. To examine the effectiveness of a combined patient and provider intervention for improving osteoarthritis outcomes. Cluster randomized clinical trial with assignment to osteoarthritis intervention and usual care groups. (ClinicalTrials.gov: NCT01130740). Department of Veterans Affairs Medical Center in Durham, North Carolina. 30 providers (clusters) and 300 outpatients with symptomatic hip or knee osteoarthritis. The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved delivery of patient-specific osteoarthritis treatment recommendations to primary care providers through the electronic medical record. The primary outcome was total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes were WOMAC function and pain subscale scores, physical performance (Short Physical Performance Battery), and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models that were adjusted for clustering of providers assessed between-group differences in improvement in outcomes. At 12 months, WOMAC scores were 4.1 points lower (indicating improvement) in the osteoarthritis intervention group versus usual care (95% CI, -7.2 to -1.1 points; P = 0.009). WOMAC function subscale scores were 3.3 points lower in the intervention group (CI, -5.7 to -1.0 points; P = 0.005). WOMAC pain subscale scores (P = 0.126), physical performance, and depressive symptoms did not differ between groups. Although more patients in the osteoarthritis intervention group received provider referral for recommended osteoarthritis treatments, the numbers who received them did not differ. The study was conducted in a single Veterans Affairs medical center. The combined patient and provider intervention resulted in modest improvement in self-reported physical function in patients with hip and knee osteoarthritis. Department of Veterans Affairs, Health Services Research and Development Service.

No difference between two types of exercise after proximal phalangeal fracture fixation: a randomised trial.

Are 6 weeks of synergistic wrist and finger exercises with the metacarpophalangeal joint constrained in an orthosis (constrained exercises) more effective than traditional finger exercises with the metacarpophalangeal joint unconstrained (unconstrained exercises) after open reduction and internal fixation of a proximal phalangeal fracture in terms of impairment, activity limitation and participation restriction at 6 and 12 weeks? Randomised, parallel-group trial with concealed allocation, intention-to-treat analysis and blinded outcome assessors. Sixty-six participants within 1 week of open reduction and internal fixation of proximal phalangeal fractures. The experimental group carried out 6 weeks of synergistic wrist and finger exercises with the metacarpophalangeal joint constrained, whilst the control group carried out finger exercises with the metacarpophalangeal joint unconstrained, as part of a comprehensive rehabilitation program. The primary outcomes were: active proximal interphalangeal joint extension of the injured finger, total active range of motion, and strength. Secondary outcomes were: pain, difficulty with specific hand activity and difficulty with usual hand activity. A blinded assessor measured outcomes at Weeks 1, 6 and 12. By Week 6, there were no significant between-group differences in improvement for: active proximal interphalangeal joint extension (MD 2 deg, 95% CI -3 to 7); total active finger range of motion (MD 0 deg, 95% CI -21 to 22); strength (MD -2kg, 95% CI -8 to 4); pain (MD 1/50, 95% CI -3 to 5); difficulty with specific hand activity (MD 2/60, 95% CI -3 to 8); or difficulty with usual hand activity (MD 0/40, 95% CI -4 to 3). By Week 12, there were also no significant between-group differences in any outcome. Constrained and unconstrained exercises has similar effects after open reduction and internal fixation of proximal phalangeal fracture. Australian New Zealand Clinical Trials Registry (ACTRN12610000294055).

Comparative Analgesic Efficacy of Oxycodone/Acetaminophen vs Codeine/Acetaminophen for Short-Term Pain Management Following ED Discharge.

To test the hypothesis that oxycodone/acetaminophen provides analgesia superior to codeine/acetaminophen following emergency department (ED) discharge. Prospective, randomized, double-blind, trial. Adult inner city ED. ED patients with acute extremity pain who were discharged home. Patients randomized to oxycodone/acetaminophen (5 mg/325 mg) or codeine/acetaminophen (30 mg/300 mg). The primary outcome, obtained via telephone one day after ED discharge, was the between-group difference in improvement in numerical rating scale (NRS) pain scores over a 2-hour period following the most recent ingestion of study drug. Secondary outcomes included proportion of patients with >50% pain reduction, side-effect profile, and patient satisfaction. Two hundred and forty patients were enrolled. Mean baseline NRS scores were 7.9 in both groups. Mean decrease over 2 hours was 4.5 NRS units in the oxycodone/acetaminophen group vs 4.2 NRS units in the codeine/acetaminophen group, for a clinically and statistically nonsignificant difference of 0.2 NRS units (95% CI -0.4-0.9 NRS units). Similarly, 66% vs 61% achieved >50% pain relief for a nonsignificant difference of 5% (95% CI -8% to 17%). Side-effect profile and patient satisfaction were similar. Our hypothesis that oxycodone/acetaminophen provides analgesia superior to codeine/acetaminophen was rejected. Although pain within each group was reduced by more than half, the between-group difference was not significant. Pending independent validation, these unexpected findings suggest that codeine/acetaminophen, a Schedule III agent, may be a clinically reasonable outpatient opioid alternative to oxycodone/acetaminophen, a more tightly restricted Schedule II agent thought to be more prone to misuse.