Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial

Background Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery. Methods A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. Discussion The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015).

ARMin - robot for rehabilitation of the upper extremities

Task-oriented repetitive movements can improve motor recovery in patients with neurological or orthopaedic lesions. The application of robotics can serve to assist, enhance, evaluate, and document neurological and orthopaedic rehabilitation. ARMin is a new robot for arm therapy applicable to the training of activities of daily living in clinics. ARMin has a semiexoskeletal structure with six degrees of freedom, and is equipped with position and force sensors. The mechanical structure, the actuators and the sensors of the robot are optimized for patient-cooperative control strategies based on impedance and admittance architectures. This paper describes the mechanical structure, the control system, the sensors and actuators, safety aspects and results of a first pilot study with hemiplegic and spinal cord injured subjects.

Short-term Functional and Patient Outcome of the Bi-cruciate Stabilized Total Knee Replacement: Prospective Consecutive Case-series

Background: Total knee replacement is the gold standard treatment for patients suffering from advanced symptomatic knee osteoarthritis. The main goals of knee prosthetics are pain reduction and restoration of knee motion. The new prostheses on the market such as the bi-cruciate stabilized Journey knee implant, promise a reconstruction of total physiological function of the knee with physiological range of motion and therefore high patient satisfaction. Purpose: The aim of this study was to analyze the patient-based Knee Injury and Osteoarthritis Outcome Score (KOOS) outcome after total knee replacement with new physiological bi-cruciate stabilized Journey knee prosthesis. Study Design: Prospective, consecutive case-series. Patients: Ninety nine patients, who received bi-cruciate stabilized Journey total knee prosthesis between January 1st 2006 and May 31st 2012, were included in the study. A single surgeon operated all patients. There were 61.1% females and the overall average age was 68 years (range 41-83 years). Left knee was replaced in 55.6%. Methods: The patients filled in KOO’s questionnaire pre- and 1 year postoperative. Range of motion (ROM) was studied preoperatively and at 1-year follow-ups. The pre- and postoperative KOOS subscores and ROM were compared using the Wilcoxon signed rank test. Results: There are significant improvements of all KOOS subscores. Ninety percent of patients have reached the minimum clinically relevant 10 points in symptoms, 94.5% in pain, 94.5% in activities of daily living, 84.9% in sport and recreation, and 90% in knee related quality of life. Postoperative, the average passive ROM was 131° (range 110-145°) and the average active ROM 122° (range 105-135°). The highest correlation coefficients ROM and the KOOS were observed for the activity and pain subscores. Very low or no correlation was seen for the sport subscore. Conclusions: Bi-cruciate stabilized knee prosthetic offers a solid outcome 1 year postoperative based on the results measured with the KOOS evaluation questionnaire. The Patients showed a generalized improvement in all domains measured in the KOOS of minimally 35, and up to over 52 points, what can be described as statistically significant. Patients described the level of functionality close to double compared to the preoperative status.

Neurostimulation for Parkinson's disease with early motor complications.

BACKGROUND Subthalamic stimulation reduces motor disability and improves quality of life in patients with advanced Parkinson's disease who have severe levodopa-induced motor complications. We hypothesized that neurostimulation would be beneficial at an earlier stage of Parkinson's disease. METHODS In this 2-year trial, we randomly assigned 251 patients with Parkinson's disease and early motor complications (mean age, 52 years; mean duration of disease, 7.5 years) to undergo neurostimulation plus medical therapy or medical therapy alone. The primary end point was quality of life, as assessed with the use of the Parkinson's Disease Questionnaire (PDQ-39) summary index (with scores ranging from 0 to 100 and higher scores indicating worse function). Major secondary outcomes included parkinsonian motor disability, activities of daily living, levodopa-induced motor complications (as assessed with the use of the Unified Parkinson's Disease Rating Scale, parts III, II, and IV, respectively), and time with good mobility and no dyskinesia. RESULTS For the primary outcome of quality of life, the mean score for the neurostimulation group improved by 7.8 points, and that for the medical-therapy group worsened by 0.2 points (between-group difference in mean change from baseline to 2 years, 8.0 points; P=0.002). Neurostimulation was superior to medical therapy with respect to motor disability (P<0.001), activities of daily living (P<0.001), levodopa-induced motor complications (P<0.001), and time with good mobility and no dyskinesia (P=0.01). Serious adverse events occurred in 54.8% of the patients in the neurostimulation group and in 44.1% of those in the medical-therapy group. Serious adverse events related to surgical implantation or the neurostimulation device occurred in 17.7% of patients. An expert panel confirmed that medical therapy was consistent with practice guidelines for 96.8% of the patients in the neurostimulation group and for 94.5% of those in the medical-therapy group. CONCLUSIONS Subthalamic stimulation was superior to medical therapy in patients with Parkinson's disease and early motor complications. (Funded by the German Ministry of Research and others; EARLYSTIM ClinicalTrials.gov number, NCT00354133.).

Sleepwalking, REM sleep behaviour disorder and overlap parasomnia in patients with Parkinson's disease

BACKGROUND/AIMS In a questionnaire survey, we identified 36 (9%) of 417 Parkinson's disease (PD) patients with sleepwalking (SW); 72% of them also had a history of REM sleep behaviour disorder (RBD). We aimed to assess the clinical and polysomnographic characteristics of SW in PD and to compare them to patients with PD with and without a history of RBD. METHODS We performed video-polysomnography and detailed clinical examination in 30 PD patients from the above-mentioned survey: 10 patients with a history of SW, 10 patients with a history of RBD, and 10 patients with no history of either SW or RBD. RESULTS PD patients with SW had higher depression, anxiety and Hoehn & Yahr scores and lower activities of daily living scores than patients without a history of RBD but did not differ from patients with RBD. Patients with SW and RBD also had more often dyskinesia and hallucinations. By polysomnography, RBD was observed in 8 patients with SW and in all patients with a history of RBD. A total of 5 patients without a history of either SW or RBD had REM sleep without atonia without behavioural peculiarities. CONCLUSION SW in PD is associated with depression, higher disease severity and functional disability. The simultaneous occurrence of SW and RBD (overlap parasomnia) in most patients suggests a common underlying disturbance of motor control during sleep in PD, with variable manifestations in different sleep stages.

Hand preference patterns in expert basketball players: Interrelations between basketball-specific and everyday life behavior

In the present study we examined the interrelation of everyday life handedness and hand preference in basketball, as an area of expertise that requires individuals being proficient with both their nondominant and dominant hand. A secondary aim was to elucidate the link between basketball-specific practice, hand preference in basketball and everyday life handedness. Therefore, 176 expert basketball players self-reported their hand preference for activities of daily living and for basketball-specific behavior as well as details about their basketball-specific history via questionnaire. We found that compared to the general population the one-hand bias was significantly reduced for both everyday life and basketball-specific hand preference (i.e., a higher prevalence of mixed-handed individuals), and that both concepts were significantly related. Moreover, only preference scores for lay-up and dribbling skills were significantly related to measures of basketball-specific practice. Consequently, training-induced modulations of lateral preference seem to be very specific to only a few basketball-specific skills, and do not generalize to other skills within the domain of basketball nor do they extend into everyday life handedness. The results are discussed in terms of their relevance regarding theories of handedness and their practical implications for the sport of basketball.

Quality of life after pulmonary embolism: validation of the French version of the PEmb-QoL questionnaire.

BackgroundThe PEmb-QoL is a validated 40-item questionnaire to quantify health-related quality of life in patients having experienced pulmonary embolism (PE). It covers six health dimensions: frequency of complaints, activities of daily living limitations, work-related problems, social limitations, intensity of complaints, and emotional complaints. Originally developed in Dutch and English, we sought to prospectively validate the psychometric properties of a French version of the PEmb-QoL.MethodsWe performed a forward and backward translation of the English version of the PEmb-QoL into French. French-speaking consecutive adult patients with an acute, objectively confirmed PE admitted to the emergency department of a Swiss university hospital between 08/2009 and 09/2011 were recruited telephonically. We used standard psychometric tests and criteria to evaluate the acceptability, reliability, and validity of the French version of the PEmb-QoL. We also performed an exploratory factor analysis.ResultsOverall, 102 patients were enrolled in the study. The French version of the PEmb-QoL showed good reliability (internal consistency, item¿total and inter-item correlations), reproducibility (test-retest reliability), and validity (convergent, discriminant) in French-speaking patients with PE. The exploratory factor analysis suggested three underlying dimensions: limitations in daily activity (items 4b-m, 5a-d), symptoms (items 1a-h and 7), and emotional complaints (items 9a-f and j).ConclusionWe successfully validated the French version of the PEmb-QoL questionnaire in patients with PE. Our results show that the PEmb-QoL is a valuable tool for assessing health-related quality of life after PE in French-speaking patients.

Complementary Medicine in Nursing Homes - Results of a Mixed Methods Pilot Study

Background ‘Kneipp Therapy’ (KT) is a form of Complementary and Alternative Medicine (CAM) that includes a combination of hydrotherapy, herbal medicine, mind-body medicine, physical activities, and healthy eating. Since 2007, some nursing homes for older adults in Germany began to integrate CAM in the form of KT in care. The study investigated how KT is used in daily routine care and explored the health status of residents and caregivers involved in KT. Methods We performed a cross-sectional pilot study with a mixed methods approach that collected both quantitative and qualitative data in four German nursing homes in 2011. Assessments in the quantitative component included the Quality of Life in Dementia (QUALIDEM), the Short Form 12 Health Survey (SF-12), the Barthel-Index for residents and the Work Ability Index (WAI) and SF-12 for caregivers. The qualitative component addressed the residents’ and caregivers’ subjectively experienced changes after integration of KT. It was conceptualized as an ethnographic rapid appraisal by conducting participant observation and semi-structured interviews in two of the four nursing homes. Results The quantitative component included 64 residents (53 female, 83.2 ± 8.1 years (mean and SD)) and 29 caregivers (all female, 42.0 ± 11.7 years). Residents were multimorbid (8 ± 3 diagnoses), and activities of daily living were restricted (Barthel-Index 60.6 ± 24.4). The caregivers’ results indicated good work ability (WAI 37.4 ± 5.1), health related quality of life was superior to the German sample (SF-12 physical CSS 49.2 ± 8.0; mental CSS 54.1 ± 6.6). Among both caregivers and residents, 89% considered KT to be positive for well-being. The qualitative analysis showed that caregivers perceived emotional and functional benefits from more content and calmer residents, a larger variety in basic care practices, and a more self-determined scope of action. Residents reported gains in attention and caring, and recognition of their lay knowledge. Conclusion Residents showed typical characteristics of nursing home inhabitants. Caregivers demonstrated good work ability. Both reported to have benefits from KT. The results provide a good basis for future projects, e.g. controlled studies to evaluate the effects of CAM in nursing homes.

Short-term functional versus patient-reported outcome of the bicruciate stabilized total knee arthroplasty: prospective consecutive case series

BACKGROUND The main goals of the standard treatment for advanced symptomatic knee osteoarthritis, total knee arthroplasty (TKA), are pain reduction and restoration of knee motion.The aim of this study was to analyse the outcome of the patient-based Knee Injury and Osteoarthritis Outcome Score (KOOS), and the surgeon-based Knee Society Score (KSS) and its Knee Score (KS) and Knee Functional Score (KFS) components after (TKA) using the Journey knee prosthesis, and to assess the correlation of these scores with range of motion (ROM). METHODS In a prospective case series study between August 1st 2008 and May 31st 2011, 99 patients, all operated by a single surgeon, received Journey bicruciate stabilized total knee prostheses. The female/male ratio was 53/34, the mean patient age at surgery was 68 years (range 41-83 years), and the left/right knee ratio was 55/44. The KOOS, range of motion, and KS and KFS were obtained preoperatively and at 1-year follow-up. The pre- and postoperative levels of the outcome measures were compared using the Wilcoxon signed-rank test. Correlation between ROM and patient outcomes was analysed with the Spearman coefficient. RESULTS All KOOS subscores improved significantly. Ninety percent of patients improved by at least the minimum clinically relevant difference of 10 points in stiffness and other symptoms, 94.5% in pain, 94.5% in activities of daily living, 84.9% in sports and recreation, and 90% in knee-related quality of life. The mean passive and active ROM improved from 122.4° (range 90-145°) and 120.4° (range 80-145°) preoperatively to 129.4° (range 90-145°) and 127.1° (range 100-145°) postoperatively. The highest correlation coefficients for ROM and KOOS were observed for the activity and pain subscores. Very low or no correlation was seen for the sport subscore.There was a significant and clinically relevant improvement of KSS (preop/postop 112.2/174.5 points), and its KS (preop/postop 45.6/86.8 points) and KFS (preop/postop 66.6/87.8 points) components. CONCLUSIONS The Journey bicruciate stabilized knee prosthesis showed good 1-year postoperative results in terms of both functional and patient-based outcome. However, higher knee ROM correlates only moderately with patient-based outcome, implying that functionality afforded by the Journey bicruciate TKA is not equivalent to patient satisfaction.

Fall-related emergency department admission: fall environment and settings and related injury patterns in 6357 patients with special emphasis on the elderly

PRINCIPALS Throughout the world, falls are a major public health problem and a socioeconomic burden. Nevertheless there is little knowledge about how the injury types may be related to the aetiology and setting of the fall, especially in the elderly. We have therefore analysed all patients presenting with a fall to our Emergency Department (ED) over the past five years. METHODS Our retrospective data analysis comprised adult patients admitted to our Emergency Department between January 1, 2006, and December 31, 2010, in relation to a fall. RESULTS Of a total of 6357 patients 78% (n = 4957) patients were younger than 75 years. The main setting for falls was patients home (n = 2239, 35.3%). In contrast to the younger patients, the older population was predominantly female (56.3% versus 38.6%; P < 0.0001). Older patients were more likely to fall at home and suffer from medical conditions (all P < 0.0001). Injuries to the head (P < 0.0001) and to the lower extremity (P < 0.019) occurred predominantly in the older population. Age was the sole predictor for recurrent falls (OR 1.2, P < 0.0001). CONCLUSION Falls at home are the main class of falls for all age groups, particularly in the elderly. Fall prevention strategies must therefore target activities of daily living. Even though falls related to sports mostly take place in the younger cohort, a significant percentage of elderly patients present with falls related to sporting activity. Falls due to medical conditions were most likely to result in mild traumatic brain injury.

Can geriatric approaches support the care of old patients in emergency departments? A review from a Swiss ED

In the coming decades, old patients will account for an increasing proportion of emergency department (ED) visits. During or after their stay in the ED, they more frequently suffer adverse outcomes than younger patients. There is evidence that specific age-centred approaches improve the outcomes. We therefore reviewed specific conditions needing particular attention in older ED patients, such as cognitive disorders and delirium, impaired mobility and falls, as well as problems related to the activities of daily living, disability, poly-pharmacy, adverse drug effects, co-morbidity and atypical presentation. We also propose steps to further improve the quality of care in older ED patients by using appropriate age-centred management.

A novel multidimensional geriatric screening tool in the ED: evaluation of feasibility and clinical relevance

PURPOSES Geriatric problems frequently go undetected in older patients in emergency departments (EDs), thus increasing their risk of adverse outcomes. We evaluated a novel emergency geriatric screening (EGS) tool designed to detect geriatric problems. BASIC PROCEDURES The EGS tool consisted of short validated instruments used to screen 4 domains (cognition, falls, mobility, and activities of daily living). Emergency geriatric screening was introduced for ED patients 75 years or older throughout a 4-month period. We analyzed the prevalence of abnormal EGS and whether EGS increased the number of EGS-related diagnoses in the ED during the screening, as compared with a preceding control period. MAIN FINDINGS Emergency geriatric screening was performed on 338 (42.5%) of 795 patients presenting during screening. Emergency geriatric screening was unfeasible in 175 patients (22.0%) because of life-threatening conditions and was not performed in 282 (35.5%) for logistical reasons. Emergency geriatric screening took less than 5 minutes to perform in most (85.8%) cases. Among screened patients, 285 (84.3%) had at least 1 abnormal EGS finding. In 270 of these patients, at least 1 abnormal EGS finding did not result in a diagnosis in the ED and was reported for further workup to subsequent care. During screening, 142 patients (42.0%) had at least 1 diagnosis listed within the 4 EGS domains, significantly more than the 29.3% in the control period (odds ratio 1.75; 95% confidence interval, 1.34-2.29; P<.001). Emergency geriatric screening predicted nursing home admission after the in-hospital stay (odds ratio for ≥3 vs <3 abnormal domains 12.13; 95% confidence interval, 2.79-52.72; P=.001). PRINCIPAL CONCLUSIONS The novel EGS is feasible, identifies previously undetected geriatric problems, and predicts determinants of subsequent care.

Home-based training to improve manual dexterity in patients with multiple sclerosis: A randomized controlled trial.

BACKGROUND Impaired manual dexterity is frequent and disabling in patients with multiple sclerosis (MS), affecting activities of daily living (ADL) and quality of life. OBJECTIVE We aimed to evaluate the effectiveness of a standardized, home-based training program to improve manual dexterity and dexterity-related ADL in MS patients. METHODS This was a randomized, rater-blinded controlled trial. Thirty-nine MS patients acknowledging impaired manual dexterity and having a pathological Coin Rotation Task (CRT), Nine Hole Peg Test (9HPT) or both were randomized 1:1 into two standardized training programs, the dexterity training program and the theraband training program. Patients trained five days per week in both programs over a period of 4 weeks. Primary outcome measures performed at baseline and after 4 weeks were the CRT, 9HPT and a dexterous-related ADL questionnaire. Secondary outcome measures were the Chedoke Arm and Hand Activity Inventory (CAHAI-8) and the JAMAR test. RESULTS The dexterity training program resulted in significant improvements in almost all outcome measures at study end compared with baseline. The theraband training program resulted in mostly non-significant improvements. CONCLUSION The home-based dexterity training program significantly improved manual dexterity and dexterity-related ADL in moderately disabled MS patients. Trial Registration NCT01507636.

Quality of life after pulmonary embolism: Prospective validation of the German version of the PEmb-QoL questionnaire.

BACKGROUND The Pulmonary Embolism Quality of Life questionnaire (PEmb-QoL) is a 40-item questionnaire to measure health-related quality of life in patients with pulmonary embolism. It covers six 6 dimensions: frequency of complaints, limitations in activities of daily living, work-related problems, social limitations, intensity of complaints, and emotional complaints. Originally developed in Dutch and English, we prospectively validated a German version of the PEmb-QoL. METHODS A forward-backward translation of the English version of the PEmb-QoL into German was performed. German-speaking consecutive adult patients aged ≥18 years with an acute, objectively confirmed pulmonary embolism discharged from a Swiss university hospital (01/2011-06/2013) were recruited telephonically. Established psychometric tests and criteria were used to evaluate the acceptability, reliability, and validity of the German PEmb-QoL questionnaire. To assess the underlying dimensions, an exploratory factor analysis was performed. RESULTS Overall, 102 patients were enrolled in the study. The German version of the PEmb-QoL showed a good internal consistency (Cronbach's alpha ranging from 0.72 to 0.96), item-total (0.53-0.95) and inter-item correlations (>0.4), and test-retest reliability (intra-class correlation coefficients 0.59-0.89) for the dimension scores. A moderate correlation of the PEmb-QoL with SF-36 dimension and summary scores (0.21-0.83) indicated convergent validity, while low correlations of PEmb-QoL dimensions with clinical characteristics (-0.16-0.37) supported discriminant validity. The exploratory factor analysis suggested four underlying dimensions: limitations in daily activities, symptoms, work-related problems, and emotional complaints. CONCLUSION The German version of the PEmb-QoL questionnaire is a valid and reliable disease-specific measure for quality of life in patients with pulmonary embolism.

Detection of muscle wasting in patients with chronic heart failure using C-terminal agrin fragment: results from the Studies Investigating Co-morbidities Aggravating Heart Failure (SICA-HF).

AIMS Skeletal muscle wasting affects 20% of patients with chronic heart failure and has serious implications for their activities of daily living. Assessment of muscle wasting is technically challenging. C-terminal agrin-fragment (CAF), a breakdown product of the synaptically located protein agrin, has shown early promise as biomarker of muscle wasting. We sought to investigate the diagnostic properties of CAF in muscle wasting among patients with heart failure. METHODS AND RESULTS We assessed serum CAF levels in 196 patients who participated in the Studies Investigating Co-morbidities Aggravating Heart Failure (SICA-HF). Muscle wasting was identified using dual-energy X-ray absorptiometry (DEXA) in 38 patients (19.4%). Patients with muscle wasting demonstrated higher CAF values than those without (125.1 ± 59.5 pmol/L vs. 103.8 ± 42.9 pmol/L, P = 0.01). Using receiver operating characteristics (ROC), we calculated the optimal CAF value to identify patients with muscle wasting as >87.5 pmol/L, which had a sensitivity of 78.9% and a specificity of 43.7%. The area under the ROC curve was 0.63 (95% confidence interval 0.56-0.70). Using simple regression, we found that serum CAF was associated with handgrip (R = - 0.17, P = 0.03) and quadriceps strength (R = - 0.31, P < 0.0001), peak oxygen consumption (R = - 0.5, P < 0.0001), 6-min walk distance (R = - 0.32, P < 0.0001), and gait speed (R = - 0.2, P = 0.001), as well as with parameters of kidney and liver function, iron metabolism and storage. CONCLUSION CAF shows good sensitivity for the detection of skeletal muscle wasting in patients with heart failure. Its assessment may be useful to identify patients who should undergo additional testing, such as detailed body composition analysis. As no other biomarker is currently available, further investigation is warranted.