Interdisciplinary and cross-sectoral perioperative care model in cardiac surgery: implementation in the setting of minimally invasive heart valve surgery (INCREASE)-study protocol for a randomized controlled trial.

BACKGROUND: Valvular heart diseases are frequent and increasing in prevalence. Minimally invasive heart valve surgery embedded in an interdisciplinary enhanced recovery after surgery (ERAS) program may have potential benefits with regard to reduced length of stay and improved patient reported outcomes. However, no prospective randomized data exist regarding the superiority of ERAS program for the patients' outcome. METHODS: We aim to randomize (1:1) a total of 186 eligible patients with minimally invasive heart valve surgery to an ERAS program vs. standard treatment at two centers including the University Medical Center Hamburg-Eppendorf, Germany, and the University Hospital Augsburg, Germany. The intervention is composed out of pre-, peri-, and postoperative components. The preoperative protocol aims at better preparation for the operation with regard to physical activity, nutrition, and psychological preparedness. Intraoperative anesthesiologic and surgical management are trimmed to enable an early extubation. Patients will be transferred to a specialized postoperative anesthesia care unit, where first mobilization occurs 3 h after surgery. Transfer to low care ward will be at the next day and discharge at the fifth day. Participants in the control group will receive treatment as usual. Primary endpoints include functional discharge at discharge and duration of in-hospital care during the first 12 months after index surgery. Secondary outcomes include health-related quality of life, health literacy, and level of physical activity. DISCUSSION: This is the first randomized controlled trial evaluating the effectiveness of an ERAS process after minimally invasive heart valve surgery. Interprofessional approach is the key factor of the ERAS process and includes in particular surgical, anesthesiological, physiotherapeutic, advanced nursing, and psychosocial components. A clinical implication guideline will be developed facilitating the adoption of ERAS model in other heart teams. TRIAL REGISTRATION: The study has been registered in ClinicalTrials.gov ( NCT04977362 assigned July 27, 2021).

The longitudinal association of symptom-related and psychological factors with health-related quality of life in patients with chronic pelvic pain syndrome.

OBJECTIVE: To analyze the course of symptom-related measures, psychological variables and health-related quality of life (HRQoL) over a 12-month period, and to longitudinally examine symptom-related and psychological factors as predictors for HRQoL in male and female patients with chronic pelvic pain syndrome (CPPS). METHODS: Data from 125 patients aged 19-83 years at baseline attending an interdisciplinary outpatient clinic for CPPS were analyzed. Participants completed a self-administered questionnaire on subjective health issues, and a postal follow-up survey was conducted 12 months later. We assessed physical and mental HRQoL, CPPS symptom severity, pain intensity, severity of somatic, depressive and anxiety symptoms, pain catastrophizing, and data on treatments during the follow-up period. Data were analyzed using multilevel linear modelling. RESULTS: CPPS symptom severity, pain intensity, and pain catastrophizing significantly decreased over time. HRQoL and levels of somatic symptoms, depressive symptoms and anxiety remained stable. Lower baseline levels of somatic symptoms were associated with an increase in physical HRQoL, and lower baseline levels of depressive symptoms, anxiety and pain catastrophizing were associated with an increase in mental HRQoL after 12 months. Treatment utilization was neither related to decrease in CPPS symptom severity, pain intensity and pain catastrophizing, nor to HRQoL after 12 months. CONCLUSIONS: Our data suggest that CPPS is related to persistently diminished HRQoL. Somatic symptoms and psychological factors are important determinants of HRQoL and potential therapeutic targets. To evaluate the efficacy and impact of treatment on CPPS-related outcomes, future large-scaled studies should systematically assess detailed data about therapies patients receive in routine care.

Physiotherapy and combined cognitive-behavioural therapy for patients with chronic pelvic pain syndrome: results of a non-randomised controlled feasibility trial.

OBJECTIVE: To explore feasibility in terms of delivering and evaluating a combination of physiotherapy and psychotherapy for patients with chronic pelvic pain syndrome (CPPS). DESIGN: Prospective non-randomised controlled pilot study. SETTING: Tertiary care facility with a specialised interdisciplinary outpatient clinic for patients with CPPS. PARTICIPANTS: A total of 311 patients was approached; 60 participated. 36 patients were included in the intervention group (mean age ±SD 48.6 years±14.8; 52.8% female) and 24 in the control group (mean age ±SD 50.6 years±14.5; 58.3% female). Fourteen participants were lost to follow-up. INTERVENTIONS: Participants were non-randomly allocated to the intervention group with two consecutive treatment modules (physiotherapy and cognitive behavioural therapy) with a duration of 9 weeks each or to the control group (treatment as usual). MAIN OUTCOME MEASURES: Feasibility was operationalised in terms of delivering and evaluating the therapeutic combination. Regarding eligibility as the first aspect of feasibility, willingness to participate, dropout and satisfaction were assessed; for the second aspect, standardised self-report questionnaires measuring health-related quality of life, depression severity and pain were applied. RESULTS: Although eligibility and willingness-to-participate rates were low, satisfaction of the participants in the intervention group was high and dropout rates were low. Results indicated a small and non-significant intervention effect in health-related quality of life and significant effects regarding depression severity and pain. CONCLUSIONS: The combination of physiotherapy and psychotherapy for patients with CPPS seems to be feasible and potentially promising with regard to effect. However, a subsequent fully powered randomised controlled trial is needed. TRIAL REGISTRATION NUMBER: German Clinical Trials Register (DRKS00009976) and ISRCTN (ISRCTN43221600).

Economic impact of enhanced recovery after surgery protocol in minimally invasive cardiac surgery.

BACKGROUND: ERAS (Enhanced Recovery After Surgery) is a multidisciplinary and integrative approach with the goal of optimizing the postoperative recovery. We aimed to analyze the economic impact of a newly established ERAS protocol in minimally invasive heart valve surgery at our institution. METHODS: ERAS protocol was implemented in 61 consecutive patients who were referred for elective minimally-invasive aortic or mitral valve surgery, between February 1, 2018 and March 31, 2019 (ERAS-group). Another 69 patients who underwent elective minimally-invasive heart valve surgery during the same time period were managed according to the hospital standards (Control-group). A detailed cost comparison analysis was carried out from a hospital perspective using a micro-costing approach. RESULTS: The total in-hospital stay was significantly shorter in the ERAS-group compared to the Control-group (6.1 ± 2.6 vs 7.7 ± 3.8 days; p = 0.008) resulting in significant cost savings of €1087.2 per patient (p = 0.003). Due to the intensified physiotherapy in the ERAS protocol, the costs for physiotherapy were €94.3 higher compared to the Control-group (p < 0.001). The total costs in the ERAS cohort were €11,200.0 ± 3029.6/patient compared to € 13,109.8 ± 4527.5/patient in the Control-Group resulting in cost savings of €1909.8 patient due to the implementation of the ERAS protocol (p = 0.006). CONCLUSION: Implementation of an ERAS-protocol in minimally-invasive cardiac surgery can be carried out safely with a fast postoperative recovery of the patient. ERAS results in a financial benefit of up to €1909 per patient and therefore will play a key role in modern cardiac surgery in the near future.

Depression Partially Mediates the Association of Adverse Childhood Experiences with Pain Intensity in Patients with Chronic Pelvic Pain Syndrome: Results from a Cross-Sectional Patient Survey.

OBJECTIVE: Adverse childhood experiences (ACEs), such as emotional and physical maltreatment, are linked to chronic pelvic pain syndrome (CPPS) in adults. Psychological factors are important in understanding CPPS. We aimed to determine the nature and frequency of ACEs in male and female patients with CPPS and to investigate whether somatic symptoms and psychological comorbidities mediate the relationship of ACE severity with pain intensity. DESIGN: Cross-sectional study. SETTING: Interdisciplinary outpatient clinic for CPPS in Hamburg, Germany. SUBJECTS: Individuals with CPPS (n = 234) who were 18 to 84 years of age. METHODS: Using a self-administered questionnaire, we assessed the history of ACEs (ACE Scale), pain intensity (McGill Pain Questionnaire), somatic symptoms (Patient Health Questionnaire-15]), depression (Patient Health Questionnaire-9), and anxiety (Generalized Anxiety Disorder Scale). Parallel mediation analysis was conducted to examine whether the association of ACE severity with pain intensity is mediated by somatic symptoms, depression, and anxiety. RESULTS: Emotional abuse and neglect were reported more than twice as often as physical abuse and neglect (37.2% vs 17.1%). Depression partially mediated the association of ACE severity with pain intensity in the whole study population. In sex-stratified analyses, different patterns of associations were observed, but somatic symptoms predicted pain intensity in both sexes. CONCLUSIONS: Emotional maltreatment was highly prevalent, supporting an increased consideration of psychological factors in CPPS and indicating the need to screen for ACEs in patients with CPPS. Findings further suggest that depression and somatic symptoms may be important targets for therapeutic interventions in patients with CPPS who have a history of childhood adversity.

Individual specialist physical activity assessment and intervention in advanced cancer patients on a palliative care ward; the 3STEPS-study.

The aim of this prospective study was to evaluate the feasibility and outcome of an activity assessment and intervention on a specialized palliative care ward. All patients admitted between May 2017 and April 2018 were screened for basic assessment (Step 1). Whenever possible the Tinetti-mobility test (TT) was performed by a physiotherapist. A comparison between physician and nurse-led assessment and patient report was performed (Step 2), followed by a low-intensity individually adapted activity intervention (Step 3). Physical function and global quality of life was measured at intervention start and at discharge. Home care training adherence was controlled by phone call. In total, 437 patients were admitted in one year. In 248 patients, a basic assessment was done of which 131 performed a TT. In this group, median age was 63 years. Types of cancer were gastrointestinal (n=39), lung (n=27), urogenital (n=20), non-cancer (n=26) and other (n=26). Median length of stay was 13 days. Correlations between assessment methods were low to moderate, the highest between the TT and the nurse led assessment. Six patients started the intervention. Four patients completed the intervention, of which two continued with the home based training. In all four patients, an improvement in outcomes was measured. In conclusion in around a quarter of patients on a palliative care ward a TT could be performed. The TT correlated to most with nurse led mobility assessment. In the few accrued patients, the activity intervention showed an effect.

Aerobic Exercise Induces Functional and Structural Reorganization of CNS Networks in Multiple Sclerosis: A Randomized Controlled Trial.

Objectives: Evidence from animal studies suggests that aerobic exercise may promote neuroplasticity and could, therefore, provide therapeutic benefits for neurological diseases such as multiple sclerosis (MS). However, the effects of exercise in human CNS disorders on the topology of brain networks, which might serve as an outcome at the interface between biology and clinical performance, remain poorly understood. Methods: We investigated functional and structural networks in patients with relapsing-remitting MS in a clinical trial of standardized aerobic exercise. Fifty-seven patients were randomly assigned to moderate-intensity exercise for 3 months or a non-exercise control group. We reconstructed functional networks based on resting-state functional magnetic resonance imaging (MRI) and used probabilistic tractography on diffusion-weighted imaging data for structural networks. Results: At baseline, compared to 30 healthy controls, patients exhibited decreased structural connectivity that was most pronounced in hub regions of the brain. Vice versa, functional connectivity was increased in hubs. After 3 months, we observed hub independent increased functional connectivity in the exercise group while the control group presented a loss of functional hub connectivity. On a structural level, the control group remained unchanged, while the exercise group had also increased connectivity. Increased clustering of hubs indicates a better structural integration and internal connectivity at the top of the network hierarchy. Conclusion: Increased functional connectivity of hubs contrasts a loss of structural connectivity in relapsing-remitting MS. Under an exercise condition, a further hub independent increase of functional connectivity seems to translate in higher structural connectivity of the whole brain.

To what extent does therapy of chronic stroke patients address participation? A content analysis of ambulatory physical and occupational therapy based on the International Classification of Functioning, Disability, and Health framework.

Purpose: The study aim was to analyze whether ambulatory therapy of chronic stroke patients contains elements that specifically address "Activity and participation", and to what extent participation as a major goal in rehabilitation is realized in ambulatory care.Method: Qualitative and quantitative content analysis of standard therapy of 71 chronic stroke patients with upper limb impairment. 469 statements on therapy of 34 therapists were analyzed using data-driven and concept-driven coding based on the International Classification of Functioning, Disability and Health framework.Results: Almost half of therapy provided to stroke patients was related to "Upper extremity" (47.5%), as one out of seven identified main categories. Regarding International Classification of Functioning, Disability, and Health framework, 75.1% of therapeutic practices in ambulatory therapy covered "Body functions," but only 13.2% addressed "Activities and participation". Some statements contained specific therapeutic concepts (9.4%) or isolated notes (2.1%) and were not linkable to the International Classification of Functioning, Disability and Health framework.Conclusions: Ambulatory therapy of chronic stroke patients is related, in part, to participation. There is potential for an increase in participation by applying therapeutic approaches, which actively involve the patients in goal-setting and therapeutic exercises to specifically address activities and participation.Implications for rehabilitationTo realize participation as a major goal in the rehabilitation process ambulatory therapy of chronic stroke patients, one should focus on therapeutic approaches and exercises that specifically address activities and participation.Structured goal-setting, which actively involve patients, can be used to identify goals relevant to individual activities and participation.

Myofascial Findings and Psychopathological Factors in Patients with Chronic Pelvic Pain Syndrome.

OBJECTIVE: Chronic pelvic pain syndrome (CPPS) is a common pain condition with psychosocial and somatic symptoms. Myofascial findings and psychiatric comorbidities are frequent. Therefore, the aim of the study was to analyze myofascial and psychosocial aspects. Furthermore, the study focuses on correlations between these aspects and gender differences in this topic. DESIGN: Cross-sectional study. SETTING: Interdisciplinary outpatient clinic for patients with CPPS at the University Medical Centre Hamburg-Eppendorf, Germany. METHODS: Participants underwent a multimodal diagnostic algorithm including physiotherapeutic assessment and psychotherapeutic evaluation. Those with a positive diagnosis of CPPS were included. Descriptive statistics were used to characterize and analyze the sample. Bivariate correlations were calculated for the association between myofascial findings and psychopathological symptoms. RESULTS: A total of 187 patients (56.7% female, mean age ± SD = 49.06 ± 17.05 years) were included. Women had significantly higher numbers of tender (mean ± SD = 17.53 ± 9.58 vs 13.40 ± 8.79, P = 0.003) and trigger points (mean ± SD = 6.23 ± 6.64 vs 4.09 ± 7.15, P = 0.036). They had also significantly higher values in the PHQ-15 (mean ± SD = 11.51 ± 5.24 vs 9.28 ± 5.49, P = 0.009) and the SF-MPQ (mean ± SD = 17.84 ± 8.95 vs 15.11 ± 7.97, P = 0.041). Several significant correlations between myofascial findings and psychosocial factors exist. CONCLUSIONS: There might be a link between psychosomatic and myofascial aspects in CPPS; thus further studies are needed. Nevertheless, the results stress the urgent need of a multimodal treatment including physiotherapy and psychotherapy in these patients.

Somatic and psychosocial determinants of symptom severity and quality of life in male and female patients with chronic pelvic pain syndrome.

AIMS: To investigate the combined impact of somatic and psychosocial factors on symptom severity and physical and mental quality of life (QoL) in male and female patients with chronic pelvic pain syndrome (CPPS). METHODS: We examined 234 patients aged 18 to 84 years attending an interdisciplinary outpatient clinic for patients with CPPS in Hamburg, Germany. Using self-reports, we assessed CPPS symptom severity (NIH-CPSI), with the female counterpart of each male anatomical site used in the questionnaire for women; physical and mental QoL (SF-12) as well as symptoms of depression (PHQ-9) and anxiety (GAD-7); pain catastrophizing cognitions (PCS); social support (F-SozU) and medication intake. The presence of trigger and tender points was assessed in a physiotherapy examination. Hierarchical multiple regression analysis was calculated to analyze the contribution of somatic and psychosocial variables on CPPS symptom severity. Analyses were repeated with physical and mental QoL as outcomes. RESULTS: In the overall model, the intake of pain medication (B = 3.78, SE = 1.25, p = .006), the presence of depressive symptoms (B = 0.40, SE = 0.15, p = .01) and pain catastrophizing (B = 0.18, SE = 0.05, p = .001) significantly predicted CPPS symptom severity. Corresponding analyses revealed a differential pattern of factors predicting physical and mental QoL, whereas higher levels of depressive symptoms were consistently associated with diminished mental (B = -0.63; p < .001) and physical QoL (B = -0.85; p < .001). CONCLUSION: Present results emphasize the importance of psychosocial factors, in particular of depression, in CPPS symptom severity and both physical and mental QoL and give support to an integrated treatment concept encompassing both psychological support and somatic aspects of the disease.

Physiotherapy management of patients with chronic pelvic pain (CPP): A systematic review.

INTRODUCTION: Chronic pelvic pain (CPP) is a common pain condition. However, treatment remains challenging. Musculoskeletal findings are frequent; therefore physiotherapy might be helpful. The purpose of this review was to evaluate the current evidence on physiotherapy in patients with CPP (PROSPERO registration number CRD42016037516). METHODS: Six databases were searched and additional hand searches were performed. Two reviewers independently conducted the database search and selected studies using a two-step approach. The methodological quality was assessed applying the Critical Review Form - Quantitative Studies. RESULTS: A total of eight studies were included. Trigger point therapy was examined in four studies; two of which were randomized controlled trials. All studies indicate a significant change in pain measurement. The other four studies evaluated the effect of biofeedback, Thiele massage, Mensendieck somatocognitive therapy and aerobic exercises, whereas the last two were tested in controlled trials. All studies showed significant improvements in pain assessment. CONCLUSIONS: The evidence currently available is sparse with methodological flaws, making it difficult to recommend a specific physiotherapy option. There is an urgent need for high-quality randomized controlled trials to identify the most effective physiotherapy management strategy for patients with CPP.

The German version of the Functional Walking Categories (FWC): translation and initial validation.

BACKGROUND: Community ambulation is often affected after a stroke. However, no validated assessment in German to measure community ambulation on a participation level exists. OBJECTIVES: The purpose was to translate and cross-culturally adapt the Functional Walking Categories (FWC) into German and to assess its validity and reliability in patients with stroke. METHODS: Cross-cultural adaptation guidelines were used for translation. Face and content validity were established with the aid of an expert committee. A pilot study with patients after stroke in a neurological rehabilitation setting checked for concurrent validity using Kendall's tau and reliability using intraclass correlation coefficients. RESULTS: The results indicated that the German version of the FWC has adequate face and content validity. A total of 30 patients (mean age 62 ± 12.315 years, 56.7% female) participated in the study. The FWC correlated well with the Functional Ambulation Categories (tau-b = 0.783), cadence (tau-b = 0.640), gait velocity (tau-b = 0.628), the comfortable 10-m timed walk (tau-b = -0.629), and the fast 10-m timed walk (tau-b = -0.634). Moderate correlations were found between the FWC and step length (tau-b = 0.483) and the Timed Up and Go (tau-b = -0.520), respectively. Intrarater reliability was moderate (ICC = 0.651) while interrater reliability was excellent (ICC = 0.751) (all correlations p < 0.001). However, the study was designed as pilot study, thus, full psychometric property testing was not possible. CONCLUSIONS: The German FWC offers a reasonable tool for measuring community ambulation on participation level. However, a user manual seems to be helpful.

Combined Cognitive-Behavioural and Physiotherapeutic Therapy for Patients with Chronic Pelvic Pain Syndrome (COMBI-CPPS): study protocol for a controlled feasibility trial.

BACKGROUND: Chronic pelvic pain syndrome (CPPS) is a pain condition perceived in the pelvic area for at least 6 months. While evidence of the aetiology and maintenance of CPPS is still unclear and therapy options are rare, there is preliminary evidence for the efficacy of cognitive behavioural therapy and physiotherapy. However, an integrated treatment has not yet been studied. The primary aim of this study is therefore to test the feasibility of combined psychotherapy and physiotherapy for female and male patients with CPPS. The secondary aim is to explore changes in patient-relevant and economic outcomes compared to a control group. METHODS: A feasibility study with a crossover design based on the principles of a 'cohort multiple randomized controlled trial' will be conducted to test a combined therapy for patients with CPPS. The study will consist of two consecutive treatment modules (cognitive behavioural group psychotherapy and physiotherapy as individual and group sessions), which will be applied in varying order. The modules will consist of nine weekly sessions with a 4-week break between the modules. The control group will undergo treatment as usual. Study subjects will be recruited from the interdisciplinary outpatient clinic for CPPS at the University Medical Center Hamburg-Eppendorf. Thirty-six patients will be assigned to the intervention, and 18 patients will be assigned to the control group. The treatment groups will be gender homogeneous. Feasibility as the primary outcome will be analysed in terms of the demand, acceptability, and practicality. Secondary study outcomes will be measured using validated self-rating-scales and physical examinations. DISCUSSION: To the best of our knowledge, this study is the first to investigate the feasibility of combined psychotherapy and physiotherapy for patients with CPPS. In addition to testing feasibility, the results can be used for the preliminary estimation of therapeutic effects. The results from this study will be used to generate an enhanced therapeutic approach, which might be subject to further testing in a larger study. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00009976 . Registered on 15 March 2016. ISRCTN, ISRCTN43221600 . Registered on 10 May 2016.

Effects of exercise on Irisin, BDNF and IL-6 serum levels in patients with progressive multiple sclerosis.

BACKGROUND: Clinical studies have suggested beneficial effects of exercise on cognitive function in ageing adults and neurodegenerative diseases such as dementia. Recent work indicates the same for progressive multiple sclerosis (MS), an inflammatory and degenerative disease of the central nervous system (CNS). The biological pathways associated with these effects are however not well understood. OBJECTIVE: In this randomized controlled study, we explored serum levels of the myokine Irisin, the neurotrophin brain-derived neurotrophic factor (BDNF) and Interleukin-6 (IL-6) during acute endurance exercise and over the course of a 9-weeks endurance exercise training period in n=42 patients with progressive MS. RESULTS: We detected a significant increase of BDNF levels in progressive MS patients after 30min of bicycling (p<0.001). However, there were no significant changes for baseline levels after 22 sessions of training. No significant effects of acute or prolonged exercise could be found for Irisin or Interleukin-6. CONCLUSION: Our results indicate that BDNF is strongly induced during acute exercise even in patients with progressive MS and advanced physical disability. Long-term effects of exercise programs on biological parameters (Irisin, BDNF, IL-6) were much less pronounced. Given the hypothesis-driven selection of a limited set of biological markers in this pilot study, future studies should use unbiased approaches in larger samples to obtain a comprehensive picture of the networks involved in exercise effects on neurological diseases.

Home-based constraint-induced movement therapy for patients with upper limb dysfunction after stroke (HOMECIMT): a cluster-randomised, controlled trial.

BACKGROUND: Constraint-induced movement therapy (CIMT) is recommended for patients with upper limb dysfunction after stroke, yet evidence to support the implementation of CIMT in ambulatory care is insufficient. We assessed the efficacy of home CIMT, a modified form of CIMT that trains arm use in daily activities within the home environment. METHODS: In this parallel, cluster-randomised controlled trial, we selected 71 therapy practices in northern Germany that treat adult patients with upper limb dysfunction after stroke. Practices were stratified by region and randomly allocated by an external biometrician (1:1, block size of four) using a computer-generated sequence. 37 practices were randomly assigned to provide 4 weeks of home CIMT and 34 practices to provide 4 weeks of standard therapy. Eligible patients had mild to moderate impairment of arm function at least 6 months after stroke and a friend or family member willing to participate as a non-professional coach. Patients of both groups received 5 h of professional therapist contact in 4 weeks. In the home CIMT group, therapists used the contact time to instruct and supervise patients and coaches in home CIMT. Patients in the standard therapy group received conventional physical or occupational therapy, but additional home training was not obligatory. All assessments were done by masked outcome assessors at baseline, after 4 weeks of intervention, and at 6 month follow-up. The primary outcomes were quality of movement, assessed by the Motor Activity Log (MAL-QOM, assessor-assisted self-reported), and performance time, assessed by the Wolf Motor Function Test (WMFT-PT, assessor-reported). Primary outcomes were tested hierarchically after 4 weeks of intervention and analysed by intention to treat, using mixed linear models. This trial is registered with ClinicalTrials.gov, NCT01343602. FINDINGS: Between July 11, 2011, and June 4, 2013, 85 of 156 enrolled patients were assigned home CIMT and 71 patients were assigned standard therapy. 82 (96%) patients in the home CIMT group and 71 (100%) patients in the standard therapy group completed treatment and were assessed at 4 weeks. Patients in both groups improved in quality of movement (MAL-QOM; change from baseline 0·56, 95% CI 0·41-0·71, p<0·0001 for home CIMT vs 0·31, 0·15-0·46, p=0·0003 for standard therapy). Patients in the home CIMT group improved more than patients in the standard therapy group (between-group difference 0·26, 95% CI 0·05-0·46; p=0·0156). Both groups also improved in motor function performance time (WMFT-PT; change from baseline -25·60%, 95% CI -36·75 to -12·49, p=0·0006 for home CIMT vs -27·52%, -38·94 to -13·94, p=0·0004 for standard therapy), but the extent of improvement did not differ between groups (2·65%, -17·94 to 28·40; p=0·8152). Nine adverse events (of which six were serious) were reported in the home CIMT group and ten (of which seven were serious) in the standard therapy group; however, none was deemed related to the study intervention. INTERPRETATION: Home-based CIMT can enhance the perceived use of the stroke-affected arm in daily activities more effectively than conventional therapy, but was not superior with respect to motor function. Further research is needed to confirm whether home CIMT leads to clinically significant improvements and if so to identify patients that are most likely to benefit. FUNDING: German Federal Ministry of Education and Research.

Physical exercise and therapy in terminally ill cancer patients: a retrospective feasibility analysis.

PURPOSE: Physical exercise (PE) and/or therapy (PT) shows beneficial effects in advanced cancer patients and is increasingly implemented in hospice and palliative care, although systematic data are rare. This retrospective study systematically evaluated the feasibility of PE/PT in terminally ill cancer patients and of different modalities in correspondence to socio-demographic and disease- and care-related aspects. METHODS: All consecutive terminally ill cancer patients treated in a palliative care inpatient ward during a 3.5-year period were included. The modalities were chosen according to the therapists' and patients' appraisal of current performance status and symptoms. RESULTS: PE/PT were offered to 572 terminally ill cancer patients, whereof 528 patients (92 %) were able to perform at least one PE/PT unit (average 4.2 units/patient). The most frequently feasible modalities were physical exercises in 50 %, relaxation therapy in 22 %, breathing training in 10 %, and positioning and lymph edema treatment in 6 % each. Physical exercise and positioning treatment were performed significantly more often in older patients (p=0.009 and p=0.022, respectively), while relaxation (p=0.05) and lymph edema treatment (p=0.001) were used more frequently in younger. Breathing training was most frequently performed in head and neck cancer (p=0.002) and lung cancer (p=0.026), positioning treatment in brain tumor patients (p=0.021), and lymph edema treatment in sarcoma patients (p=0.012). CONCLUSIONS: PE/PT were feasible in >90 % of terminally ill cancer patients to whom PE/PT had been offered. Physical exercises, relaxation therapy, and breathing training were the most frequently applicable methods. Prospective trials are needed to evaluate the efficacy of specific PE/PT programs in terminally ill cancer patients.

Enhancing activities of daily living of chronic stroke patients in primary health care by modified constraint-induced movement therapy (HOMECIMT): study protocol for a cluster randomized controlled trial.

BACKGROUND: Stroke leads to constant rehabilitation needs even at the chronic stage. However, although many stroke patients receive physical or occupational therapy in primary health care, treatment prescriptions do not generally specify therapeutic goals; in particular, participation is not established as an explicit therapeutic goal in the ambulatory setting. The primary aim of this study is to evaluate the efficacy of a therapy regimen for chronic stroke patients (modified 'constraint-induced movement therapy (CIMT) at home') with impaired hand or arm function with regard to the prerequisites of participation in everyday activities: a sufficient arm and hand function. 'CIMT at home' will be compared with conventional physical and occupational therapy ('therapy as usual'). METHODS/DESIGN: The study is a parallel cluster randomized controlled trial with therapy practices as clusters (n = 48). After written consent from the patients (n = 144), the therapists will be randomly assigned to treat either the intervention or the control group. Blinded external assessors will evaluate the patients using standardized outcome measures before and after the intervention, and six months later. The two coprimary endpoint assessments of arm and hand function as prerequisites for participation (defined as equal involvement in activities of daily living) are the motor activity log (quality of arm and hand use) and the Wolf motor function test (arm and hand function). These assessments are made four weeks post-treatment and relativized to baseline performance. Changes in primary outcomes will be analyzed with mixed models, which consider the hierarchical structure of the data and will be adjusted to the baseline measurements and sex. The primary analysis will be the comparison of the two randomized groups, with respect to the adjusted averages for each of the two coprimary endpoints. To keep an overall significance level of 5%, the two endpoints will be tested at the significance level of 5% each in hierarchical order. DISCUSSION: A modification of the CIMT, feasible in the patients' homes (CIMT at home), appears to be a promising therapeutic approach in the ambulatory care of chronic stroke patients. With proven efficacy and practicality, a participation-oriented, stroke-specific treatment would be available in primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT01343602.

Comparison of two types of Constraint-Induced Movement Therapy in chronic stroke patients: A pilot study.

UNLABELLED: Several studies showed that Constraint-Induced Movement Therapy (CIMT) leads to a lasting improvement of upper extremity function in chronic stroke patients. The original technique includes an intensive 2-week program with 6 hours of daily physiotherapy. Due to high expenses it is difficult to implement this concept in outpatient care. PURPOSE: The objective of this study was to evaluate the effects of a 4-week homebased CIMT program among chronic stroke patients and to compare them with a 2-week CIMT program, based on the original technique. METHODS: Seven adults with chronic stroke completed a newly developed variant of CIMT, performed at patients' homes (group1, CIMThome), supervised by an instructed family member, constraint of unaffected hand for a target of 60% of waking hours. The intervention was analysed with pre-, post-treatment and 6-month follow-up measurements. Effects on improvement in upper extremity function were compared with patients treated according to the original protocol (group2, CIMTclassic), supervised by a physiotherapist, constraint of unaffected hand for a target of 90% of waking hours. RESULTS: Patients from both groups showed almost identical improvement of their motor function according to scores on the Wolf Motor Function Test (WMFT) and the Motor Activity Log (MAL) immediately after the treatment period as well as at follow-up after 6 months. CONCLUSIONS: Our study suggests that CIMThome is not only feasible but also as effective as CIMTclassic. This finding should be replicated in a larger prospective randomized trial to perform a non-inferiority analysis.

Repeat therapy for chronic motor stroke: a pilot study for feasibility and efficacy.

BACKGROUND: . Therapeutic interventions improve outcomes in the acute and chronic phase after motor stroke, but a significant amount of this improvement is usually lost after more than 1 year. Patients might profit from a second course of intensive physiotherapy, but this has not been investigated. OBJECTIVE: . The feasibility and effect of a second phase of physiotherapy was examined 2 years after the first one. METHODS: . A total of 12 patients with chronic stroke were instructed to wear a constraining splint on the affected elbow and hand while awake for 4 weeks and practice individually tailored tasks 2 hours per day. Motor tests for assessment included the Motor Activity Log, Wolf Motor Function Test, and 9-Hole Peg Test. RESULTS: . In the 11 patients who were available for postintervention assessment, the deterioration in the amount and quality of movement that had occurred since the first therapy was largely recouped. Patients who wore the constraint more than 80% of waking hours during the second therapy showed a clear secondary improvement in all tests, in some surpassing the level reached after the first therapy. CONCLUSIONS: . A repeated bout of home-based CIMT 2 years after initial training is feasible with relatively little time and effort provided by a therapist and can lead to further improvement.