A Bayesian analysis of non-significant rehabilitation findings: Evaluating the evidence in favour of truly absent treatment effects

BackgroundRelying solely on null hypothesis significance testing (NHST) to investigate rehabilitation interventions may result in researchers erroneously concluding the absence of a treatment effect.ObjectiveWe aimed to distinguish between truly null treatment effects and data that are insensitive to detecting treatment effects by calculating Bayes factors (BF₀₁s) for non-significant findings in the rehabilitation literature. Additionally, to examine associations between BF₀₁, sample size, and observed P-values.MethodWe searched the Cochrane Database of Systematic Reviews for meta-analyses with “rehabilitation” as a keyword that clearly evaluated a rehabilitation intervention. We extracted means, standard deviations, and sample sizes for treatment and comparison groups for individual findings within 175 meta-analyses. Two independent investigators classified the interventions into 4 categories using the Rehabilitation Treatment Specification System. We calculated t-statistics and associated P-values for each finding in order to extract non-significant results (P > 0.05). We calculated BF₀₁s for 5790 non-significant results and classified BF₀₁s based on the strength of evidence in favour of the null hypothesis (i.e., anecdotal, moderate, and strong) across and within intervention types. We examined correlations between BF₀₁, sample size, and P-values across and within intervention types.ResultsAcross all intervention types, most (71.9%) findings were deemed anecdotal, and this pattern remained within distinct intervention types (58.4–76.0%). Larger sample sizes tended to be associated with greater strength in favour of the null hypothesis, both across and within intervention types. Larger P-values were not associated with greater strength in favour of the null hypothesis; this finding was present both across and within intervention types.ConclusionOur findings indicate that most non-significant rehabilitation findings are unable to distinguish between the true absence of a treatment effect and data that are merely insensitive to detecting a treatment effect. Findings also suggest that rehabilitation researchers may improve the strength of their statistical conclusions by increasing sample size and that Bayes factors may offer unique benefits relative to P-values.     

Effect of high-intensity exercise on cardiorespiratory fitness in stroke survivors: A systematic review and meta-analysis

BackgroundKnowledge of the optimal protocol and safety of particularly high-intensity exercise applied to individuals with stroke is lacking.ObjectiveThis systematic review and meta-analysis aimed to investigate the effect of high-intensity exercise on cardiorespiratory fitness in stroke survivors.MethodsWe performed a systematic electronic search for articles in MedLine via PubMed, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials, CINAHL, and SPORTSDiscus up to April 1, 2019. Peak oxygen consumption (VO₂peak), 6-min walk test (6MWT), fastest 10-m walk test (10MWT), and adverse events were assessed. The standardized mean difference (SMD), weighted mean difference (WMD), and odds ratios (ORs) were used to compute the effect size, and subgroup analysis was conducted to test the consistency of results as well as sensitivity analysis to assess the robustness of the results. The quality of evidence was assessed with the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system.ResultsWe included 17 studies (PEDro score ≥ 4) in the meta-analysis. Post-intervention, high-intensity exercise had a significant effect on peak oxygen uptake (VO₂peak; SMD = 0.56, P < 0.01, I² = 8%; WMD = 2.53 mL/kg/min; high quality of evidence) and 6MWT (SMD = 0.26, P < 0.01, I² = 40%; WMD = 17.08 m; moderate quality of evidence) but not fastest 10MWT (SMD = 0.33, P = 0.27, I² = 77%; WMD = 0.05 m/s; low quality of evidence). Subgroup analysis showed better effects of higher-intensity treadmill training (≥ 70% heart rate reserve/VO₂peak) for a longer duration (≥ 12 weeks) on VO₂peak and 6MWT in sub-acute or chronic stroke survivors. The high-intensity exercise and control groups did not differ in adverse events including falls [odds ratio (OR) 1.40, P = 0.35, I² = 11%; low quality of evidence], pain (OR 3.34, P = 0.09, I² = 0%; moderate quality of evidence), or skin injuries (OR 1.08, P = 0.90, I² = 0%; low quality of evidence).ConclusionsOur meta-analysis suggests that high-intensity exercise is beneficial for cardiorespiratory fitness in stroke survivors and might be safe as a novel intervention in cardiopulmonary rehabilitation after stroke.     

Comparison of the clinical effectiveness of thermal cure and rehabilitation in knee osteoarthritis. A randomized therapeutic trial

ObjectiveTo compare the benefits of a thermal cure and non-thermal rehabilitation in treatment of knee osteoarthritis (KOA).MethodsRandomized therapeutic trial including patients with knee osteoarthritis (American College of Rheumatology criteria). Patients were randomly divided into two groups. Spa treatment consisted of underwater shower, massage-jet showers, hydromassage, pool rehabilitation and peloid therapy. Non-thermal rehabilitation consisted of analgesic physiotherapy, muscle strengthening and group physical rehabilitation. A blinded evaluation was carried out at day 21 and 12 months following treatment. It was based on the visual analogic scale of pain (VAS), which represented the primary endpoint.ResultsTwo hundred and forty patients were included (February–June 2005). The spa treatment and non-thermal rehabilitation groups included 119 and 121 patients respectively. Two hundred and thirty-three patients completed their treatments. Significant improvement of the visual analogic scale of pain was noted in the thermal cure group (61.6 ± 15 at day 0 versus 46.5 ± 22.4 at 12 months, P < 0.001), but not in the non-thermal group (64.1 ± 15 at day 0 versus 62 ± 29 at 12 months, P = 0.68). At day 21, comparison of the two groups revealed no significant difference on the VAS (P = 0.08). However, at 12 months, the thermal cure group was significantly more improved (P = 0.000).ConclusionIn our study, crenobalneotherapy had resulted, at 12 months, in more pronounced long-term improvement of the painful symptoms of KOA than had non-thermal rehabilitation.     

Axial and torsional stiffness of pediatric prosthetic feet

BackgroundProsthetic stiffness likely affects the walking biomechanics of toddlers and children with leg amputations, but the actual stiffness values for prostheses are not reported by manufacturers or in standardized testing procedures.AimWe measured axial (k_A) and torsional (k_T) stiffness from four brands of pediatric prosthetic feet (Trulife, Kingsley Mfg. Co., TRS Incorporated, and College Park Industries) over a range of foot sizes.MethodsWe applied forces and torques onto prostheses with a materials testing machine that replicated those exhibited in vivo by using the kinetics measured from four non-amputee toddlers (2–3 years) during walking.FindingsAcross brands, k_A averaged 35.2 kN/m during heel loading, was more stiff during midfoot loading (121.8 kN/m,  P < 0.001) and less stiff during forefoot loading (11.8 kN/m,  P = 0.013). k_A was similar across brands with no statistically significant effect of prosthetic foot size, with the exception of the TRS feet. Plantarflexion torsional stiffness (k_T1), was not statistically different across brands. For every 1 cm increase in foot size, k_T1 increased 0.16 kN·m/rad ( P < 0.001). College Park prostheses had 4.54 kN·m/rad lower dorsiflexion torsional stiffness (k_T2) ( P < 0.001) compared to other brands. For every 1 cm increase in foot size, the k_T2 applied on the foot increased 0.63 kN·m/rad.InterpretationThe axial and torsional stiffness testing methods are reproducible and should be adopted by prosthetic foot manufacturers. Axial and torsional stiffness values of commercially available prosthetic feet should be publically reported to health practitioners to ensure evidence-based decisions and meet the specific needs of each patient with a leg amputation.     

Patient transfer from a rehabilitation hospital to an emergency department : A retrospective study of an American trauma center

ObjectiveTo analyze medical indications and conditions for patients transferred from a rehabilitation hospital to an emergency department (ED). Are there differences in terms of which patients go to the ED during their stay and which do not? Specifically, what type of patient is most likely to be transferred?MethodologyA retrospective study was conducted at an American adult and pediatric urban trauma center that serves 40,000 patients per year. This study compared randomly selected samples of 534 patients having been transferred to the ED from a rehabilitation hospital and 500 patients who were directly admitted to the ED from the community. Variables examined were: demographics, ED diagnosis and level of care, length of hospital stay, costs, discharge condition and return within 60 days to the ED.ResultsThe patients transferred from the rehabilitation hospital were older (P < 0.01), differed with regard to ethnicity (83% African American; P < 0.01), the reason for hospitalization (P < 0.01; the majority presented with cardiovascular disease, respiratory disease or altered mental status), had longer and more expensive stays (average: 4–8 days, P < 0.01), required a higher level of care (P < 0.01), were more often admitted to surgery or telemetry, and, lastly, were more likely to be discharged in a frail or poor condition (P < 0.01).ConclusionsThe patients transferred from a rehabilitation hospital had complex, intense medical (and often psychological) issues. These patients’ medical needs required a high level of resources in the ED. They frequently left the hospital in sub-optimal conditions, making it likely that they would return to the hospital via the ED prior to completing their treatment within the rehabilitation hospital.     

Effect of self-tailored high-intensity interval training versus moderate-intensity continuous exercise on cardiorespiratory fitness after myocardial infarction: A randomised controlled trial

BackgroundWhether high-intensity interval training (HIIT) is more efficient than moderate-intensity continuous exercise (MICE) to increase cardiorespiratory fitness in patients with acute coronary syndrome at moderate-to-high cardiovascular risk is controversial. The best approach to guide training intensity remains to be determined.ObjectiveWe aimed to assess intensities achieved with self-tailored HIIT and MICE according to perceived exertion and to compare the effect on cardiorespiratory fitness in patients early after ST-elevation myocardial infarction (STEMI).MethodsWe included 69 males starting cardiac rehabilitation within 4 weeks after STEMI. After a 3-week run-in phase with MICE, 35 patients were randomised to 9 weeks of HIIT (2 × HIIT and 1 × MICE per week) and 34 patients to MICE (3 × MICE). Training workload for MICE was initially set at the patients’ first ventilatory threshold (VT). HIIT consisted of 4 × 4-min intervals with a workload above the second VT in high intervals. Training intensity was adjusted weekly to maintain the perceived exertion (Borg score 13–14 for MICE, ≥ 15 for HIIT). Session duration was 38 min in both groups. Peak oxygen consumption (VO₂) was measured by cardiopulmonary exercise testing pre- and post-intervention.ResultsBoth groups improved peak VO₂ (ml/kg/min) (HIIT +1.9, P < 0.001; MICE +3.2, P < 0.001, Cohen's d ?0.4), but changes in VO₂ were not significantly different between groups (P = 0.104). Exercise regimes did not differ between groups in terms of energy expenditure or training time, but perceived exertion was higher with HIIT.ConclusionsSelf-tailored HIIT was feasible in patients early after STEMI. It was more strenuous but not superior nor more time-efficient than MICE in improving peak VO₂.The trial was registered at ClinicalTrial.gov (NCT02627586).     

Impact of Kinect-based virtual reality training on physical fitness and quality of life in severely burned children: A monocentric randomized controlled trial

Pediatric burns lead to persistent and detrimental muscle breakdown, weakness and poor quality of life, so rehabilitation is integral for improving physical and psychological outcomes. However, children with burns are a major challenge to a rehabilitation team. To overcome these challenges, enjoyable and interesting interventions are suggested. Objective: we aimed to determine the impact of the Xbox Kinect on cardiopulmonary fitness, muscle strength, lean mass, quality of life and enjoyment in severely burned children after hospital discharge. Methods: this was a randomized controlled trial in a single centre. Participants (n = 40 children) with burn injuries were randomized to the Xbox training group (n = 20) or control group (n = 20) during 12 weeks. All children received a home programme rehabilitation and Xbox training children received Xbox training. Outcomes included cardiopulmonary fitness (VO₂peak), muscle strength (peak torque), lean mass (whole-body and regional), quality of life and physical activity enjoyment at baseline, immediately after hospital discharge, and 12 weeks after the intervention. Results: the mean (SD) age of the 40 children was 12.97 (1.42) years and total body surface area of burn was 51% (5). The groups did not differ in characteristics at baseline (P > 0.05). After 12 weeks of the intervention, the groups significantly differed in VO₂peak, peak torque, quality of life (P < 0.001), lean mass and leg lean mass (P < 0.05) in favour of Xbox training. The mean difference in VO₂peak, peak torque, lean mass and leg lean mass was 3.25 (2.1; 4.5) ml/kg/min, 7.5 (5.8; 9.2) Nm, 1.81 (0.5; 3.1) kg, and 1.1 (0.1; 2.1) kg, respectively. Lean trunk mass did not significantly differ between groups (P = 0.07). The Xbox training group reported significantly more enjoyment than did the control group (P < 0.001). Conclusion: Xbox Kinect training can increase cardiopulmonary fitness, muscle strength, lean mass and quality of life in burned children. It is one of the most enjoyable, motivated and efficient treatment modalities that should be widely introduced into the pediatric burn rehabilitation. Trial registration. ClinicalTrials.gov (ID: NCT04350034).     

Decrease in post-stroke spasticity and shoulder pain prevalence over the last 15 years

ObjectivesThe usual complications after recent stroke such as disabling spasticity and shoulder pain seemed less frequent in recent years. This study examined the frequency of spasticity and shoulder pain in recent post-stroke patients over time in our physical and rehabilitation medicine department.MethodsThis was a retrospective study of post-stroke inpatients over the last 15 years. Spasticity and shoulder pain prevalence were analyzed, as were demographic, clinical and stroke characteristics.ResultsWe reviewed medical records for 786 patients (506 men); mean age 58.1 years (SD 13.2); 530 (68%) with ischemic stroke and 256 (32.36%) hemorrhagic stroke. After a first increase from 2000 to 2006, the prevalence of disabling spasticity decreased from 2006 to 2015 (31%–10%; P < 0.001). Shoulder pain at admission and during hospitalization also decreased (13% of patients in 2000 to 8% in 2015, P < 0.001). Disabling spasticity was associated with shoulder pain (26% of patients with disabling spasticity presented shoulder pain at admission vs 7% with hyperreflexia of the deep tendon reflexes, P < 0.05). Characteristics of stroke, time of admission after stroke and length of stay did not change over the years. We observed an increase in number of walking patients at admission and number with a functional paretic arm at admission and discharge (P < 0.05), which may explain the increase in functional independence measure scores at admission and discharge (both P < 0.05). Prevalence of cognitive disorders increased over the same period (24% in 2000 vs 63% in 2015, P < 0.05).ConclusionsDisabling spasticity and shoulder pain frequency in recent post-stroke patients decreased over the last 15 years, and functional abilities both at admission and discharge improved. Confirmation of these results in a multicentric study may be important evidence of an improvement in stroke healthcare both in stroke and physical and rehabilitation medicine units in the last 10 years in France and could affect future estimations of the need for rehabilitation care after stroke.     

Local vibration training improves the recovery of quadriceps strength in early rehabilitation after anterior cruciate ligament reconstruction: A feasibility randomised controlled trial

BackgroundAfter anterior cruciate ligament reconstruction (ACLR), quadriceps strength must be maximised as early as possible.ObjectivesWe tested whether local vibration training (LVT) during the early post-ACLR period (i.e., ～10 weeks) could improve strength recovery.MethodsThis was a multicentric, open, parallel-group, randomised controlled trial. Thirty individuals attending ACLR were randomised by use of a dedicated Web application to 2 groups: vibration (standardised rehabilitation plus LVT, n = 16) or control (standardised rehabilitation alone, n = 14). Experimenters, physiotherapists and participants were not blinded. Both groups received 24 sessions of standardised rehabilitation over ～10 weeks. In addition, the vibration group received 1 hour of vibration applied to the relaxed quadriceps of the injured leg at the end of each rehabilitation session. The primary outcome — maximal isometric strength of both injured and non-injured legs (i.e., allowing for limb asymmetry measurement) — was evaluated before ACLR (PRE) and after the 10-week rehabilitation (POST).ResultsSeven participants were lost to follow-up, so data for 23 participants were used in the complete-case analysis. For the injured leg, the mean (SD) decrease in maximal strength from PRE to POST was significantly lower for the vibration than control group (n = 11, ?16% [10] vs. n = 12, ?30% [11]; P = 0.0045, Cohen's d effect size = 1.33). Mean PRE–POST change in limb symmetry was lower for the vibration than control group (?19% [11] vs. ?29% [13]) but not significantly (P = 0.051, Cohen's d effect size = 0.85).ConclusionLVT improved strength recovery after ACLR. This feasibility study suggests that LVT applied to relaxed muscles is a promising modality of vibration therapy that could be implemented early in ACLR.Trial registrationClinicalTrials.gov: NCT02929004.     

Effects of a low-intensity dynamic-resistance training protocol using an isokinetic dynamometer on muscular strength and aerobic capacity after coronary artery bypass grafting

ObjectiveStudy the effect of muscle strength training on muscle strength, maximal oxygen uptake (VO₂max), hemodynamic and anthropometric parameters as well as quality of life after coronary artery bypass grafting (CABG).MethodsAfter CABG surgery, 32 patients were randomized into two groups. The first group was to perform aerobic-type training with a cycle ergometer (AT = 16). The second group was to perform low-intensity muscle strength training of the quadriceps and hamstrings using an isokinetic dynamometer (i.e. 20 to 30% of peak torque) (ST = 16). Before and after the strength training program we conducted a stress test, evaluation of isokinetic force production, 6-minute walking test, body impedance analysis (BIA) and SF-36 quality of life test.ResultsCompared to the AT group, the ST group showed better results with improved quadriceps strength (48.2% vs. 8.2%), VO₂max (P < .001) and diastolic blood pressure at rest (P = 0.01). Quality of life improved in both groups.ConclusionThe dynamic-resistance muscle strength training protocol using isokinetic dynamometer can safely (i.e. without clinical symptoms or changes to the ECG and arterial blood pressure) improve muscle strength and VO₂max without any major risks in patients post-CABG. These findings should encourage additional studies to validate the relevance of these strength training modalities in rehabilitation centers.     

Extracorporeal shock wave therapy for treating dyspareunia: A prospective,randomized, double-blind,placebo-controlled study

BackgroundDyspareunia is a genital pain during or after penile-vaginal sexual intercourse. It is a painful spasm of the pelvic muscles that partly or entirely disables vaginal penetration.ObjectivesWe examined the effect of extracorporeal shock wave therapy (ESWT) on idiopathic non-organic dyspareunia in women. A prospective, randomized, double-blind, placebo-controlled study was conducted.MethodsThe study included 62 women who reported dyspareunia. Patients in the treatment and placebo groups received ESWT perineally weekly for 4 consecutive weeks; placebo patients received placebo stand-off treatment. The grade of dyspareunia was estimated by using the Marinoff Dyspareunia Scale and subjective pain intensity on a visual analog scale (VAS) before and after treatment. Follow-ups were conducted 1, 4 and 12 weeks after the final ESWT session.ResultsThe study included 61 women. The treatment but not placebo group differed by the Marinoff Dyspareunia Scale and VAS. Differences before and after treatment within groups were all P < 0.001 and between groups, P < 0.001. Pain reduction was always > 30%. The effect sizes were both large: Marinoff 0.825 and VAS 0.883.ConclusionsESWT significantly reduced subjective pain in our women treated for dyspareunia.     

Effectiveness of upper-limb robotic-assisted therapy in the early rehabilitation phase after stroke: A single-blind,randomised, controlled trial

BackgroundUpper-limb robotic-assisted therapy (RAT) is promising for stroke rehabilitation, particularly in the early phase. When RAT is provided as partial substitution of conventional therapy, it is expected to be at least as effective or might be more effective than conventional therapy. Assessments have usually been restricted to the first 2 domains of the International classification of functioning, disability and health (ICF).ObjectiveThis was a pragmatic, multicentric, single-blind, randomized controlled trial to evaluate the effectiveness of upper-limb RAT used as partial substitution to conventional therapy in the early phase of stroke rehabilitation, following the 3 ICF domains.MethodsWe randomized 45 patients with acute stroke into 2 groups (conventional therapy, n = 22, and RAT, n = 23). Both interventions were dose-matched regarding treatment duration and lasted 9 weeks. The conventional therapy group followed a standard rehabilitation. In the RAT group, 4 sessions of conventional therapy (25%) were substituted by RAT each week. RAT consisted of moving the paretic upper limb along a reference trajectory while the robot provided assistance as needed. A blinded assessor evaluated participants before, just after the intervention and 6 months post-stroke, according to the ICF domains UL motor impairments, activity limitations, and social participation restriction.ResultsIn total, 28 individuals were assessed after the intervention. The following were more improved in the RAT than conventional therapy group at 6 months post-stroke: gross manual dexterity (Box and Block test +7.7 blocks; P = 0.02), upper-limb ability during functional tasks (Wolf Motor Function test +12%; P = 0.02) and patient social participation (Stroke Impact Scale +18%; P = 0.01). Participants’ abilities to perform manual activities and activities of daily living improved similarly in both groups.ConclusionFor the same duration of daily rehabilitation, RAT combined with conventional therapy during the early rehabilitation phase after stroke is more effective than conventional therapy alone to improve gross manual dexterity, upper-limb ability during functional tasks and patient social participation.     

A ventilation technique for oxygenation and carbon dioxide elimination in CPR: Continuous insufflation of oxygen at three levels of pressure in a pig model

AimPulmonary ventilation remains an important part of cardiopulmonary resuscitation, affecting gas exchange and haemodynamics. We designed and studied an improved method of ventilation for CPR, constructed specifically to support both gas exchange and haemodynamics. This method uses continuous insufflation of oxygen at three levels of pressure, resulting in tri-level pressure ventilation (TLPV). We hypothesized that TLPV improves gas exchange and haemodynamics compared to manual gold standard ventilation (GSV).MethodsIn 14 pigs, ventricular fibrillation was induced and automated CPR performed for 10 min with either TLPV or GSV. After defibrillation, CPR was repeated with the other ventilation method. Gas exchange and haemodynamics were monitored. Data are presented as mean ± standard error of the mean.ResultsTLPV was superior to GSV for PaO₂ (163 ± 36 mmHg difference; P = 0.001), and peak AWP (−20 ± 2 cmH₂O difference; P = 0.000) and higher for mean AWP (8 ± 0.2 cmH₂O difference; P = 0.000). TLPV was comparable to GSV for CPP (5 ± 3 mmHg difference; P = 0.012), VCO₂ (0.07 ± 0.3 mL/min/kg difference; P = 0.001), SvO₂ (4 ± 3%-point; P = 0.001), mean carotid flow (−0.5 ± 4 mL/min difference; P = 0.016), and pH_a (0.00 ± 0.03 difference; P = 0.002). The PaCO₂ data do not provide a conclusive result (4 ± 4 mmHg difference).ConclusionWe conclude that the ventilation strategy with a tri-level pressure cycle performs comparable to an expert, manual ventilator in an automated-CPR swine model.     

Rehabilitation of 190 non-ambulatory children with cerebral palsy in structures of care or in liberal sector

AimsTo describe the rehabilitation of non-ambulatory children with cerebral palsy and to explore adjustability on their individual needs.Material and methodData described are extracted from an on-going national cohort study, following during 10 years 385 children with cerebral palsy, aged from 4 to 10, Gross Motor Function Classification System IV and V. We analysed data from the first 190 patients (mean age 6 years 10 months (SD 2.0), 111 boys), focusing on physiotherapy, ergotherapy, psychomotility and speech therapy in medico-social and liberal sectors.ResultsIn medico-social sector, duration of paramedical care is significantly more important than in liberal sector (structure of care: median = 4.25 h/week, liberal sector: median = 2.00 h/week) (P < 0.0001). More than 4 different types of care per week are given in medico-social sector, while in liberal sector children benefit from only 2 different types of care a week. In investigators opinion, rehabilitation in structures of care is 71.65% adapted as opposed to 18.75% in the liberal sector (P < 0.001). Children level V have less time of rehabilitation than the others (P = 0.0424).InterpretationRehabilitation of children with cerebral palsy who are not able to walk, with an objective to improve quality of life, is truly multidisciplinary and suitable in medico-social sector.     

Mobile health and supervised rehabilitation versus mobile health alone in breast cancer survivors: Randomized controlled trial

BackgroundSurvival rates in cancer are increasing exponentially, with a corresponding increase/influence in disability-adjusted life-years. Efforts should be made to explore the optimal balance between unsupervised/distance-based and supervised/onsite approaches to cancer care.ObjectiveThis study aimed to compare the clinical efficacy of the BENECA mobile Health (mHealth) lifestyle application combined with a supervised rehabilitation program (BENECA and supervised rehabilitation) versus the BENECA mHealth lifestyle application alone on quality of life (QoL) and functional outcomes of breast cancer survivors.MethodsThis randomized controlled trial included 80 survivors of breast cancer diagnosed at stage I–IIIA, who completed adjuvant therapy and were overweight or obese at diagnosis. Participants were randomly allocated (ratio 1:1, 3 waves) to BENECA mHealth and rehabilitation for 2 months (n = 40) or BENECA mHealth and usual care (BENECA mHealth alone; n = 40). Participants completed a questionnaire at baseline (T1), 8-weeks post-intervention (T2) and 6-month follow-up (T3). The primary outcome was QoL assessed with the EORT QLQ-C30. Secondary outcomes included upper-limb functionality and body composition. Statistical (between-group analyses of covariance) and clinical effects were analyzed by intention to treat.ResultsBoth groups showed improved outcomes, but global QoL was significantly better with BENECA mHealth and rehabilitation than BENECA mHealth alone (mean difference, 12.76; 95% confidence interval 4.85; 20.67; P = 0.004), with a moderate-to-large effect size (d = 72). The proportion of participants reporting reliable clinical improvement on global QoL at T2 was higher with BENECA mHealth and rehabilitation than BENECA mHealth alone (57.5% vs 26.3%, P = 0.008). Improvement in subjective and objective upper-limb functionality was also higher with BENECA mHealth and rehabilitation.ConclusionsThe BENECA mHealth lifestyle application with a supervised rehabilitation program had a statistically and clinically significant effect on QoL and upper-limb functionality in breast cancer survivors and is a unique and important promising new approach.     

Transcranial direct current stimulation as an adjunct to cognitive training for older adults with mild cognitive impairment: A randomized controlled trial

BackgroundCognitive training (CT) for individuals with mild cognitive impairment (MCI) may not be optimal for enhancing cognitive functioning. Coupling CT with transcranial direct current stimulation (tDCS) may maximize the strength of transmission across synaptic circuits in pathways that are stimulated by CT. The synergistic effects arising from this combination could be superior to those with administration of CT alone.ObjectivesTo investigate whether the receiving tDCS combined with CT is superior to CT alone on domain-specific and task-specific cognitive outcomes in older adults with MCI.MethodsThis double-blind, sham-controlled randomized trial included 67 older adults with MCI assigned to 3 groups: 1) tDCS combined with CT (tDCS + CT), 2) sham tDCS combined with CT (sham tDCS + CT) and 3) CT alone. Nine sessions of computerized CT were administered to the 3 groups for 3 weeks. In addition, tDCS and sham tDCS was delivered to the left dorsolateral prefrontal cortex to the tDCS + CT and sham tDCS + CT groups, respectively, simultaneously with CT. Standardized cognitive assessments were performed at baseline, post-intervention, and at 6-week follow-up. Participants’ performance in the CT tasks was rated every session.ResultsThe 3 groups showed improvements in global cognition and everyday memory (P < 0.017) after the intervention and at follow-up, with larger effect sizes in the tDCS + CT than other groups (d > 0.94) but with no significant differences between groups. Regarding CT outcomes, the groups showed significant differences in favour of the tDCS + CT group in decreasing the completion and reaction times of working memory and attention activities (P < 0.017).ConclusionstDCS combined with CT was not superior to sham tDCS with CT and CT alone in its effects on domain-specific cognitive outcomes, but it did provide comparatively larger effect sizes and improve the processing speed of task-specific outcomes.ClinicalTrials.govNCT03441152.     

Association of R230C ABCA1 gene variant with low HDL-C levels and abnormal HDL subclass distribution in Mexican school-aged children

BackgroundThe effect of ABCA1 genetic variation on HDL-C levels has been widely documented, although studies in children are scarce. We recently found a frequent non-synonymous ABCA1 variant (R230C) exclusive to populations with Native American ancestry, associated with low HDL-C levels and other metabolic traits in adults.MethodsWe genotyped R230C variant in 1253 healthy unrelated Mexican school-aged children aged 6–15 years (595 boys and 658 girls) to seek associations with HDL-C levels and other metabolic traits. HDL subclass distribution was analyzed in a subgroup of 81 age, gender and BMI-matched children.ResultsIndividuals carrying the C230 allele showed a significantly lower HDL-C levels (P = 2.9 × 10^? 8), and higher TC/HDL-C ratio, BMI, BMI z-score and percent fat mass (P = 0.001, 0.049, 0.032 and 0.039, respectively). HDL size was smaller in R230C heterozygotes as compared to R230R homozygotes (P < 0.05). Moreover, the proportion of HDL_2b was lower, while the proportion of HDL_3a and HDL_3b particles was higher in R230C heterozygous and/or C230C homozygous individuals as compared to R230R homozygotes (P < 0.05).ConclusionsOur data suggest that the R230C ABCA1 gene variant plays an important role in HDL-C level regulation and HDL subclass distribution in healthy Mexican school-aged children.     

The minimal important difference for Glittre-ADL test in patients with chronic obstructive pulmonary disease

ObjectiveTo determine Glittre-ADL test minimal important difference in patients with chronic obstructive pulmonary disease.MethodsThis is quasi-experimental study. Sixty patients with moderate to very severe chronic obstructive pulmonary disease (age 64.1, SD = 9.09 years; forced expiratory volume in the first second 37.9, SD = 13.0% predicted participated in a pulmonary rehabilitation program based on physical training, conducted over 24 sessions supervised, three times a week, including aerobic training in treadmill and resistance training for upper limbs and lower limbs. The main outcomes were the Glittre-ADL test and six-minute walk test, before and after 24 sessions of pulmonary rehabilitation. The minimal important difference was established using the distribution and anchor-based methods.ResultsPatients improved their functional capacity after the pulmonary rehabilitation. The effect sizes of Glittre-ADL test and six-minute walk test improvement were similar (0.45 vs 0.44, respectively). The established minimal important differences ranged from −0.38 to −1.05. The reduction of 0.38 min (23 s) corresponded to a sensitivity of 64% and a specificity of 69% with an area under the curve of 0.66 (95%CI 0.51–0.81; p = 0.04). Subjects who achieved the minimal important difference of −0.38 min for the Glittre-ADL test had a superior improvement of approximately 42 m in the six-minute walk test when compared to patients who did not.ConclusionsThe present findings suggest −0.38 min as the minimal important difference in the time spent in the Glittre-ADL test after 24 sessions of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease.Trial registration: NCT03251781 (https://clinicaltrials.gov/ct2/show/NCT03251781)     

Short-term effects of a 3-week interval training program on heart rate variability in chronic heart failure. A randomised controlled trial

BackgroundExaggerated sympathetic nervous system activity associated with low heart rate variability (HRV) is considered to trigger cardiac arrhythmias and sudden death. Regular exercise training is efficient to improve autonomic balance.ObjectiveWe aimed to verify the superiority of high-intensity interval training (HIIT) to enhance HRV, cardiorespiratory fitness and cardiac function as compared with moderate intensity continuous training (MICT) in a short, intense cardiac rehabilitation program.MethodsThis was a prospective, monocentric, evaluator-blinded, randomised (1:1) study with a parallel two-group design. Overall, 31 individuals with voluntary chronic heart failure (CHF) (left ventricular ejection fraction [LVEF] < 45%) were allocated to MICT (n = 15) or HIIT (n = 16) for a short rehabilitation program (mean [SD] 27 [4] days). Participants underwent 24-hr electrocardiography, echocardiography and a cardiopulmonary exercise test at entry and at the end of the study.ResultsHigh-frequency power in normalized units (HFnu%) measured as HRV increased with HIIT (from 21.2% to 26.4%, P < 0.001) but remained unchanged with MICT (from 23.1% to 21.9%, P = 0.444, with a significant intergroup difference, P = 0.003). Resting heart rate (24-hr Holter electrocardiography) decreased significantly for both groups (from 68.2 to 64.6 bpm and 66.0 to 63.5 bpm for MICT and HIIT, respectively, with no intergroup difference, P = 0.578). The 2 groups did not differ in premature ventricular contractions. Improvement in peak oxygen uptake was greater with HIIT than MICT (+ 21% vs. + 5%, P = 0.009). LVEF improved with only HIIT (from 36.2% to 39.5%, P = 0.034).ConclusionsIn this short rehabilitation program, HIIT was significantly superior to the classical MICT program for enhancing parasympathetic tone and peak oxygen uptake.ClinicalTrials.gov identifierNCT03603743     

Self-rehabilitation combined with botulinum toxin to improve arm function in people with chronic stroke. A randomized controlled trial

BackgroundBotulinum toxin injection (BTI) reduces muscle hyperactivity, but its effect on active upper-limb function is limited. Intensive rehabilitation could optimize the effects; however, outpatient post-stroke rehabilitation is usually not intensive. One solution could be self-rehabilitation.ObjectivesThe aim of this randomized controlled trial was to determine the effect of a self-rehabilitation program combined with BTI on upper-limb function in individuals with chronic hemiparesis.MethodsIn total, 33 outpatients were randomly allocated to receive BTI + self-rehabilitation (R group: n = 17) or BTI alone (C group: n = 16). Outcomes evaluated just before the BTI and 4 weeks later included the Wolf Motor Function Test (WMFT time: primary outcome), Action Research Arm Test, fatigue and quality of life.ResultsChange in WMFT did not differ between groups at 4 weeks (WMFT time: ?14% for R group, ?4% for C group. WFMT score: +12% for R group, 0% in C group). WFMT time and score improved significantly in the R group only (?14%, P = 0.01, and +12%, P = 0.02). In addition, the proportion of patients with improved WMFT time and score was higher in the R than C group (R group: 71% improved score, 77% improved time; C group: 43% improved score, 50% improved time). Also, passive range of shoulder flexion (P = 0.03) and wrist extension (P = 0.01) improved only in the R group. No other variables changed significantly. Compliance was excellent; average daily training time was greater than that prescribed.ConclusionsThe addition of a self-rehabilitation program to BTI did not significantly improve functional outcomes more than BTI alone; however, movement quality and speed improved only in the self-rehabilitation group. Participants in the self-rehabilitation group trained more than they were asked to, which suggests that they found the program worthwhile. These clinically relevant findings justify larger-scale studies of the effects of self-rehabilitation to enhance the effects of BTI. Clinical trial: NCT02699762.