Effects of an early multidisciplinary intervention on sickness absence in patients with persistent low back pain-a randomized controlled trial.

BACKGROUND: Multidisciplinary rehabilitation is recommended to reduce sickness absence and disability in patients with subacute or chronic low back pain (LBP). This study aimed to investigate whether a 12-week coordinated work oriented multidisciplinary rehabilitation intervention was effective on return to work and number of days off work during one-year follow-up when compared to usual care. METHODS: This study is a randomized controlled trial comparing the effectiveness of a 12-week multidisciplinary vocational rehabilitation program in addition to usual treatment. 770 patients with LBP, who were sick-listed, or at risk of being sick-listed were included in the study. The primary outcome was number of days off work due to LBP. The secondary outcomes were disability, health-related quality of life, pain, psychological distress and fear avoidance behavior. Data were collected at baseline, at the end of treatment, and at 6- and 12-months follow-up. Analyses were carried out according to the "intention-to-treat" principles. RESULTS: A significant decrease in the number of patients who were on sick-leave was found in both groups at the end of treatment and at 6- and 12-months follow-up. Additionally, disability, pain, health related quality of life, psychological distress, and fear avoidance beliefs improved in both groups. No statistically significant differences were found between the groups on any of the outcomes. CONCLUSIONS: The coordinated multidisciplinary intervention had no additional effect on sickness absence, disability, pain, or health related quality of life as compared with that of usual care. TRIAL REGISTRATION: This study was retrospectively registered in ClinicalTrials.gov (registration ID: NCT01690234). The study was approved by The Danish Regional Ethics Committee (file no: H-C-2008-112) as well as registered at and approved by the Danish Data Protection Agency.

Concurrent Validity Between Electronically Administered Physical Activity Questionnaires and Objectively Measured Physical Activity in Danish Community-Dwelling Older Adults.

AIM: To investigate the concurrent validity of the International Physical Activity Questionnaire-short form (IPAQ-SF) and the Nordic Physical Activity Questionnaire-short (NPAQ-short) when compared with objectively measured daily steps among older adults. METHODS: Spearman's ρ between IPAQ-SF and NPAQ-short and objectively measured steps using Garmin Vivofit 3 physical activity monitors. RESULTS: A total of 54 participants were included. The IPAQ-SF subscales' moderate physical activity (PA), moderate to vigorous PA (MVPA), and sedentary time showed little or no correlation with daily steps. The NPAQ-short subscales' vigorous PA, moderate PA, and MVPA showed little or no correlation. The IPAQ-SF subscales' vigorous PA and walking showed fair correlation. Only the IPAQ-SF metabolic equivalent of task minutes showed moderate to good correlation with daily steps. The IPAQ-SF categories and NPAQ-short categorization of World Health Organization compliance were significantly different, but the magnitudes were small and distributions indicated problems with the categorization. CONCLUSION: The concurrent validity is low, as the scores did not reflect objectively measured daily steps.

The MIPAM trial: a 12-week intervention with motivational interviewing and physical activity monitoring to enhance the daily amount of physical activity in community-dwelling older adults - a study protocol for a randomized controlled trial.

BACKGROUND: Physical Activity Monitors (PAMs) have been shown to effectively enhance level of physical activity (PA) in older adults. Motivational interviewing is a person-centred model where participants are guided using self-reflection and counselling, and addresses the behavioural and psychological aspects of why people initiate health behaviour change by prompting increases in motivation and self-efficacy. The addition of motivational interviewing to PA interventions may increase the effectiveness of PAMs for older adults. METHODS: This motivational interviewing and PA monitoring trial is designed as an investigator-blinded, two arm parallel group, randomized controlled superiority trial with primary endpoint after 12 weeks of intervention. The intervention group will receive a PAM-based intervention and motivational interviewing and the control group will only receive the PAM-based intervention. The primary outcome is PA, objectively measured as the average daily number of steps throughout the intervention period. Secondary outcome measures include self-reported PA health-related quality of life, loneliness, self-efficacy for exercise, outcome expectancy for exercise, and social relations. The outcomes will be analysed with a linear regression model investigating between-group differences, adjusted for baseline scores. Following the intention to treat principle, multiple imputation will be performed to handle missing values. DISCUSSION: A moderate effect of daily PA measured using PAMs is expected in this superiority RCT investigating the effect of adding motivational interviewing to a PAM intervention. According to the World Health Organization, walking and cycling are key activities in regular PA and should be promoted. To increase the general public health and lower the burden of inactivity in older adults, cost-beneficial solutions should be investigated further. If this RCT shows that motivational interviewing can enhance the effect of PAM-based interventions, it might be included as an add-on intervention when appropriate. No matter what the results of this study will be, the conclusions will be relevant for clinicians as the dependence on technology is increasing, especially in relation to public health promotion. TRIAL REGISTRATION: NCT03906162 , April 1, 2019.

Danish general practitioners' management of patients with COPD: a nationwide survey.

BACKGROUND: In Denmark, general practitioners (GPs) have the main responsibility for chronic obstructive pulmonary disease (COPD) management. Internationally, COPD appears to be significantly under-treated, which could be explained by 'therapeutic nihilism' or lack of knowledge. AIM: To investigate: (1) To what extent COPD management provided by GPs includes the core elements of pharmacological treatment, smoking cessation and physical activity, and (2) To what extent GPs need educational support and consulting with a specialist in pulmonary medicine. DESIGN: A national cross-sectional web-based survey conducted in April-June 2019. The survey included items on COPD management and educational support needs. SETTING: Danish general practice. SUBJECTS: A population of approximately 3400 GPs (all GPs in Denmark). RESULTS: We received response from 470 GPs (14% response rate). Overall, the respondents reported that they offered COPD management including all relevant treatment elements. Smoking cessation was supported in 58% and physical activity was supported in 23% of the respondents. Future consultations on smoking cessation were planned by 35% and physical activity by 15% respondents. GPs responded to 'needing educational support in COPD management' to a 'high degree' in 8% and to 'some degree' in 43%. CONCLUSION: The survey suggested that COPD maintenance support provided by GPs seemed to be inadequate regarding smoking cessation and physical activity. Moreover, some GPs expressed a need for educational support in COPD management. More research is needed to understand the potential barriers to evidence-based delivery of COPD-management. Key points In Denmark, general practitioners (GPs) have the main responsibility for the management of chronic obstructive pulmonary disease (COPD). The present study shows that non-pharmacological interventions such as supporting smoking cessation and particularly promoting physical activity received less attention than pharmacological treatment. The study suggests a need for educational support of the GPs in COPD management.

Type 2 diabetes remission 1 year after an intensive lifestyle intervention: A secondary analysis of a randomized clinical trial.

AIM: To investigate whether an intensive lifestyle intervention induces partial or complete type 2 diabetes (T2D) remission. MATERIALS AND METHODS: In a secondary analysis of a randomized, assessor-blinded, single-centre trial, people with non-insulin-dependent T2D (duration <10 years), were randomly assigned (2:1, stratified by sex, from April 2015 to August 2016) to a lifestyle intervention group (n = 64) or a standard care group (n = 34). The primary outcome was partial or complete T2D remission, defined as non-diabetic glycaemia with no glucose-lowering medication at the outcome assessments at both 12 and 24 months from baseline. All participants received standard care, with standardized, blinded, target-driven medical therapy during the initial 12 months. The lifestyle intervention included 5- to 6-weekly aerobic and combined aerobic and strength training sessions (30-60 minutes) and individual dietary plans aiming for body mass index ≤25 kg/m2 . No intervention was provided during the 12-month follow-up period. RESULTS: Of the 98 randomized participants, 93 completed follow-up (mean [SD] age 54.6 [8.9] years; 46 women [43%], mean [SD] baseline glycated haemoglobin 49.3 [9.3] mmol/mol). At follow-up, 23% of participants (n = 14) in the intervention and 7% (n = 2) in the standard care group met the criteria for any T2D remission (odds ratio [OR] 4.4, 95% confidence interval [CI] 0.8-21.4]; P = 0.08). Assuming participants lost to follow-up (n = 5) had relapsed, the OR for T2D remission was 4.4 (95% CI 1.0-19.8; P = 0.048). CONCLUSIONS: The statistically nonsignificant threefold increased remission rate of T2D in the lifestyle intervention group calls for further large-scale studies to understand how to implement sustainable lifestyle interventions among people with T2D.

High volume injection with and without corticosteroid in chronic midportion achilles tendinopathy.

BACKGROUND: High volume injection (HVI) shows promising results in the treatment of chronic midportion Achilles tendinopathy (AT). HVI consists of a large volume of saline with a small amount of corticosteroid and local anesthetic. OBJECTIVE: To determine the effect of corticosteroid in HVI in AT. METHODS: A total of 28 men (18-59 years) with chronic (>3 months) AT were included in a double-blinded RCT and followed for 24 weeks. All performed eccentric training and randomized to either (a) HVI injection with corticosteroid or (b) HVI injection without corticosteroid. Outcomes included self-reported function (VISA-A score) and pain (VAS score) and ultrasound imaging (tendon thickness, Doppler flow). RESULTS: VISA-A and VAS score improved in both groups at all time-points (P < 0.05). VISA-A improvement was significantly greater in HVI with corticosteroid (mean ± SEM; 6-weeks = 31 ± 3 points; 12-weeks = 32 ± 5 points) vs HVI without corticosteroid (6 weeks = 14 ± 3; 12-weeks = 17 ± 3) at 6 and 12 weeks (P < 0.05), but not at 24 weeks. Decrease in VAS scores was significantly greater in HVI with corticosteroid (6 weeks = 55 ± 3 mm; 12 weeks = 53 ± 5 mm) vs HVI without corticosteroid (6 weeks = 16 ± 3 mm; 12 weeks = 25 ± 5 mm) at 6 and 12 weeks (P < 0.05) but not at 24 weeks. Tendon thickness decreased significantly in both groups at all time-points (P < 0.05), but more in the HVI with corticosteroid vs HVI without corticosteroid at 6 and 12 weeks (P < 0.05) but not at 24 weeks. CONCLUSION: High volume injection with or without corticosteroid in combination with eccentric training seems effective in AT. HVI with corticosteroid showed a better short-term improvement than HVI without corticosteroid indicating a short-term effect of corticosteroid in HVI treatment of AT.

Histological and Molecular Adipose Tissue Changes Are Related to Metabolic Syndrome Rather Than Lipodystrophy in Human Immunodeficiency Virus-Infected Patients: A Cross-Sectional Study.

Background: In human immunodeficiency virus (HIV)-infected patients on combination antiretroviral therapy (cART), lipodystrophy shares many similarities with metabolic syndrome, but only metabolic syndrome has objective classification criteria. We examined adipose tissue changes related to lipodystrophy and metabolic syndrome to clarify whether it may be acceptable to focus diagnosis on metabolic syndrome rather than lipodystrophy. Methods: This is a cross-sectional study of 60 HIV-infected men on cART and 15 healthy men. We evaluated lipodystrophy (clinical assessment) and metabolic syndrome (JIS-2009). We compared adipocyte size, leukocyte infiltration, and gene expression in abdominal subcutaneous adipose tissue biopsies of patients with and without lipodystrophy and with and without metabolic syndrome. Results: Lipodystrophy was only associated with increased macrophage infiltration (P = .04) and adiponectin messenger ribonucleic acid ([mRNA] P = .008), whereas metabolic syndrome was associated with larger adipocytes (P < .0001), decreased expression of genes related to adipogenesis and adipocyte function (P values between <.0001 and .08), increased leptin mRNA (P = .04), and a trend towards increased expression of inflammatory genes (P values between .08 and .6). Conclusions: Metabolic syndrome rather than lipodystrophy was associated with major unfavorable abdominal subcutaneous adipose tissue changes. In a clinical setting, it may be more relevant to focus on metabolic syndrome diagnosis in HIV-infected patients on cART with regards to adipose tissue dysfunction and risk of cardiometabolic complications.

Modulation of task-related cortical connectivity in the acute and subacute phase after stroke.

The functional relevance of cortical reorganization post-stroke is still not well understood. In this study, we investigated task-specific modulation of cortical connectivity between neural oscillations in key motor regions during the early phase after stroke. EEG and EMG recordings were examined from 15 patients and 18 controls during a precision grip task using the affected hand. Each patient attended two sessions in the acute and subacute phase (median of 3 and 34 days) post-stroke. Dynamic causal modelling (DCM) for induced responses was used to investigate task-specific modulations of oscillatory couplings in a bilateral network comprising supplementary motor area (SMA), dorsal premotor cortex (PMd) and primary motor cortex (M1). Fourteen models were constructed for each subject, and the input induced by the experimental manipulation (task) was set to inferior parietal lobule (IPL). Bayesian model selection favoured a fully connected model. A reduced coupling from SMA and intact M1 in the γ-band (31-48 Hz) to lesioned M1 in the ß-band (15-30 Hz) was observed in patients in the acute phase compared to controls. Behavioural performance improved significantly in the subacute phase, while an increased positive coupling from intact PMd to lesioned M1 and a less negative modulation from lesioned M1 to intact M1 were observed for patients compared to controls both from the γ-band to the ß-band. We infer that the observed differences in cross-frequency cortical interactions are important for functional recovery.

Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

Importance: It is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes. Objective: To test whether an intensive lifestyle intervention results in equivalent glycemic control compared with standard care and, secondarily, leads to a reduction in glucose-lowering medication in participants with type 2 diabetes. Design, Setting, and Participants: Randomized, assessor-blinded, single-center study within Region Zealand and the Capital Region of Denmark (April 2015-August 2016). Ninety-eight adult participants with non-insulin-dependent type 2 diabetes who were diagnosed for less than 10 years were included. Participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34). Interventions: All participants received standard care with individual counseling and standardized, blinded, target-driven medical therapy. Additionally, the lifestyle intervention included 5 to 6 weekly aerobic training sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training. The lifestyle participants received dietary plans aiming for a body mass index of 25 or less. Participants were followed up for 12 months. Main Outcomes and Measures: Primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 12-month follow-up, and equivalence was prespecified by a CI margin of ±0.4% based on the intention-to-treat population. Superiority analysis was performed on the secondary outcome reductions in glucose-lowering medication. Results: Among 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA1c, 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA1c level changed from 6.65% to 6.34% in the lifestyle group and from 6.74% to 6.66% in the standard care group (mean between-group difference in change of -0.26% [95% CI, -0.52% to -0.01%]), not meeting the criteria for equivalence (P = .15). Reduction in glucose-lowering medications occurred in 47 participants (73.5%) in the lifestyle group and 9 participants (26.4%) in the standard care group (difference, 47.1 percentage points [95% CI, 28.6-65.3]). There were 32 adverse events (most commonly musculoskeletal pain or discomfort and mild hypoglycemia) in the lifestyle group and 5 in the standard care group. Conclusions and Relevance: Among adults with type 2 diabetes diagnosed for less than 10 years, a lifestyle intervention compared with standard care resulted in a change in glycemic control that did not reach the criterion for equivalence, but was in a direction consistent with benefit. Further research is needed to assess superiority, as well as generalizability and durability of findings. Trial Registration: clinicaltrials.gov Identifier: NCT02417012.

Influence of pre-pregnancy leisure time physical activity on gestational and postpartum weight gain and birth weight - a cohort study.

In order to examine the association between pre-pregnancy leisure time physical activities and gestational weight gain, postpartum weight gain and birth weight, we analysed prospectively collected data from 1827 women with singleton term pregnancies. Women were categorised in groups of sedentary women, light exercisers, moderate exercisers and competitive athletes. The results showed that sedentary women on average gained 14.1 kg during pregnancy, whereas light exercisers gained 13.7 kg, moderate exercisers gained 14.3 kg and competitive athletes 16.1 kg. Competitive athletes had an increased risk of having a gestational weight gain above Institute of Medicine (IOM) recommendations with an odds ratio of 2.60 (1.32-5.15) compared to light exercisers. However, birth weight and one year postpartum weight was similar for all four groups. Thus, although competitive athletes gain more weight than recommended during pregnancy, this may not affect birth weight or postpartum weight. Impact statement What is already known on this subjectPrevious studies have found that increased pre-pregnancy physical activity is associated with lower gestational weight gain during the last trimester, but showed no association between the pre-pregnancy level of physical activity and mean birth weight. What the results of this study addWe found that women classified as competitive exercisers had a 2.6-fold increased risk of gaining more weight than recommended compared to light exercisers. Nearly 6 out of 10 women among the competitive exercisers gained more weight than recommended by IOM. Surprisingly, this did not appear to increase birth weight or post-partum weight gain, but other adverse effects cannot be excluded. What the implications are of these findings for clinical practice and/or further researchIn the clinical practice it may be relevant to focus on and advise pre-pregnancy competitive exercisers in order to prevent excessive gestational weight gain.

The Effect of Game-Based Interventions in Rehabilitation of Diabetics: A Systematic Review and Meta-Analysis.

INTRODUCTION: Game-based interventions have been proposed as a way to improve both patient adherence to physical activity (PA) and disease-related knowledge to achieve better self-management of blood glucose levels (HbA1c). The objective of this study was to systematically review the literature on the effect of game-based interventions on HbA1c, diabetes-related knowledge, and physical outcomes in rehabilitation of diabetes patients. METHODS: We conducted a systematic literature search in MEDLINE, EMBASE, PEDro, Scopus, Cochrane Central Register of Controlled Trials, CINAHL, and Psych INFO in October 2014 based on a priori defined inclusion criteria: patients with diabetes (type 1 or type 2), game-based interventions, and randomized controlled trials. RESULTS: The database search identified 1,101 potential articles for screening, four of which were eligible for the present systematic review. Game-based interventions show no effect on HbA1c (three studies) standardized mean difference = -0.10, 95% confidence interval = [-0.33, 0.14] compared to usual care or waiting lists. Game-based interventions were superior to controls in improving health-related quality of life, muscle strength, and balance (one study). No difference was found between game-based interventions and usual care or waiting lists in terms of diabetes-related knowledge (one study). DISCUSSION: PA is important for diabetes management. The present review indicates that game-based interventions are not superior to ordinary PA in controlling HbA1c. Due to the weak methodological quality of the included studies and the very low body of evidence, the likelihood that the real effect of game-based interventions will be substantially different (i.e., large enough difference to possibly affect decision-making) is high.

Comparison of mental distress in patients with low back pain and a population-based control group measured by Symptoms Check List--A case-referent study.

PURPOSE: Mental distress is common in persons experiencing low back pain and who are sick-listed or at risk of being sick-listed. It is, however, not known how mental distress measured by the Symptoms Check List-90 differs between patients with low back pain and the general population. The objective of this study was to compare mental symptoms and distress as measured by the Symptoms Check List-90 in sick-listed or at risk of being sick-listed patients with low back pain with a population-based control group. METHODS: Mental distress was compared in a group of patients with low back pain (n=770) and a randomly selected population-based reference group (n=909). Established Danish cut-off values for mental distress were used to evaluate the mental distress status in the low back pain and control group and logistic regression was used to calculate odds ratios for the Global Severity Index and the symptom scales of the Symptoms Check List-90 while controlling for baseline demographic differences between the groups. RESULTS: Group mean scores showed that all symptom scales and the Global Severity Index for both sexes were statistically elevated in the low back pain group, except for interpersonal sensitivity in women. When the scores were dichotomized to cases and non-cases of mental distress, a significantly higher prevalence of cases was observed in the low back pain group compared to the reference group on all symptom check list scales, except for paranoid ideation for both sexes and interpersonal sensitivity for women. The biggest between-group difference was observed for the somatization symptom scale. CONCLUSIONS: Low back pain patients who are sick-listed or at risk of being sick-listed, are more mentally distressed compared to a randomly selected sample of the general Danish population. Self-reported symptoms of somatization, anxiety, phobic anxiety, obsessive-compulsive, depression and hostility are all more common among patients with low back pain compared to the general population.

3-D ultrastructure and collagen composition of healthy and overloaded human tendon: evidence of tenocyte and matrix buckling.

Achilles tendinopathies display focal tissue thickening with pain and ultrasonography changes. Whilst complete rupture might be expected to induce changes in tissue organization and protein composition, little is known about the consequences of non-rupture-associated tendinopathies, especially with regards to changes in the content of collagen type I and III (the major collagens in tendon), and changes in tendon fibroblast (tenocyte) shape and organization of the extracellular matrix (ECM). To gain new insights, we took biopsies from the tendinopathic region and flanking healthy region of Achilles tendons of six individuals with clinically diagnosed tendinopathy who had no evidence of cholesterol, uric acid and amyloid accumulation. Biochemical analyses of collagen III/I ratio were performed on all six individuals, and electron microscope analysis using transmission electron microscopy and serial block face-scanning electron microscopy were made on two individuals. In the tendinopathic regions, compared with the flanking healthy tissue, we observed: (i) an increase in the ratio of collagen III : I proteins; (ii) buckling of the collagen fascicles in the ECM; (iii) buckling of tenocytes and their nuclei; and (iv) an increase in the ratio of small-diameter : large-diameter collagen fibrils. In summary, load-induced non-rupture tendinopathy in humans is associated with localized biochemical changes, a shift from large- to small-diameter fibrils, buckling of the tendon ECM, and buckling of the cells and their nuclei.

Perioperative rehabilitation in operation for lung cancer (PROLUCA) - rationale and design.

BACKGROUND: The purpose of the PROLUCA study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise. METHODS: Using a 2 x 2 factorial design with continuous effect endpoint (Maximal Oxygen Uptake (VO2peak)), 380 patients with non-small cell lung cancer (NSCLC) stage I-IIIa referred for surgical resection will be randomly assigned to one of four groups: (1) preoperative and early postoperative rehabilitation (starting two weeks after surgery); (2) preoperative and late postoperative rehabilitation (starting six weeks after surgery); (3) early postoperative rehabilitation alone; (4) today's standard care which is postoperative rehabilitation initiated six weeks after surgery. The preoperative rehabilitation program consists of an individually designed, 30-minute home-based exercise program performed daily. The postoperative rehabilitation program consists of a supervised group exercise program comprising cardiovascular and resistance training two-hour weekly for 12 weeks combined with individual counseling. The primary study endpoint is VO2peak and secondary endpoints include: Six-minute walk distance (6MWD), one-repetition-maximum (1RM), pulmonary function, patient-reported outcomes (PROs) on health-related quality of life (HRQoL), symptoms and side effects of the cancer disease and the treatment of the disease, anxiety, depression, wellbeing, lifestyle, hospitalization time, sick leave, work status, postoperative complications (up to 30 days after surgery) and survival. Endpoints will be assessed at baseline, the day before surgery, pre-intervention, post-intervention, six months after surgery and one year after surgery. DISCUSSION: The results of the PROLUCA study may potentially contribute to the identification of the optimal perioperative rehabilitation for operable lung cancer patients focusing on exercise initiated immediately after diagnosis and rehabilitation shortly after surgery. TRIAL REGISTRATION: NCT01893580.

Deployment and validation of the CLL treatment infection model adjoined to an EHR system.

Research algorithms are seldom externally validated or integrated into clinical practice, leaving unknown challenges in deployment. In such efforts, one needs to address challenges related to data harmonization, the performance of an algorithm in unforeseen missingness, automation and monitoring of predictions, and legal frameworks. We here describe the deployment of a high-dimensional data-driven decision support model into an EHR and derive practical guidelines informed by this deployment that includes the necessary processes, stakeholders and design requirements for a successful deployment. For this, we describe our deployment of the chronic lymphocytic leukemia (CLL) treatment infection model (CLL-TIM) as a stand-alone platform adjoined to an EPIC-based Danish Electronic Health Record (EHR), with the presentation of personalized predictions in a clinical context. CLL-TIM is an 84-variable data-driven prognostic model utilizing 7-year medical patient records and predicts the 2-year risk composite outcome of infection and/or treatment post-CLL diagnosis. As an independent validation cohort for this deployment, we used a retrospective population-based cohort of patients diagnosed with CLL from 2018 onwards (n = 1480). Unexpectedly high levels of missingness for key CLL-TIM variables were exhibited upon deployment. High dimensionality, with the handling of missingness, and predictive confidence were critical design elements that enabled trustworthy predictions and thus serves as a priority for prognostic models seeking deployment in new EHRs. Our setup for deployment, including automation and monitoring into EHR that meets Medical Device Regulations, may be used as step-by-step guidelines for others aiming at designing and deploying research algorithms into clinical practice.

Myogenic, matrix, and growth factor mRNA expression in human skeletal muscle: effect of contraction intensity and feeding.

INTRODUCTION: We examined short-term (3-hour) and long-term (12-week) training effects after heavy load [HL; 70% 1RM] and light load (LL; 16% 1RM) exercise. METHODS: mRNA expression of genes involved in skeletal muscle remodeling were analyzed and muscle activity (EMG measurements) was measured. RESULTS: Relative muscle activity differed between HL and LL resistance exercise, whereas median power frequency was even, suggesting an equal muscle-fiber-type recruitment distribution. mRNA expression of Myf6, myogenin, and p21 was mostly increased, and myostatin was mostly depressed by HL resistance exercise. No major differences were seen in atrophy-related genes between HL and LL resistance exercise. No changes were seen over 12-week training for any of the targets. CONCLUSIONS: Resistance exercise at LL and HL elevated the expression of genes involved in skeletal muscle hypertrophy, although the greatest response was from HL. However, no long-term effect from either LL or HL resistance exercise was seen on basal levels of the mRNA targets.

The effect of acute exercise on collagen turnover in human tendons: influence of prior immobilization period.

Mechanical loading of human tendon stimulates collagen synthesis, but the relationship between acute loading responses and training status of the tendon is not clear. We tested the effect of prolonged load deprivation on the acute loading-induced collagen turnover in human tendons, by applying the same absolute load to a relative untrained Achilles tendon (2-week immobilization period prior to acute loading) and a habitually loaded contra-lateral Achilles tendon, respectively, within the same individuals. Eight untrained, healthy males had one lower limb totally immobilized for 2 weeks, whereas the contra-lateral leg was used habitually. Following the procedure both Achilles tendons and calf muscles were loaded with the same absolute load during a 1-h treadmill run. Tissue collagen turnover was measured by microdialysis performed post-immobilization but pre-exercise around both Achilles tendons and compared to values obtained by 72-h post-exercise. Power Doppler was used to monitor alterations in intratendinous blood flow velocity of the Achilles tendon and MRI used to quantitate changes in tendon cross-section area. Acute loading resulted in an increased collagen synthesis 72 h after the run in both Achilles tendons (p < 0.05) with no significant difference. No signs of acute tendon overloading were demonstrated by Power Doppler, and tendon cross-section area did not change as a result of immobilization and reloading. The present study indicates that 2 weeks of tendon load deprivation is not sufficient to affect the normal adaptive response to loading determined as increased collagen synthesis of peritendinous Achilles tendon tissue in humans.

No inflammatory gene-expression response to acute exercise in human Achilles tendinopathy.

Although histology data favour the view of a degenerative nature of tendinopathy, indirect support for inflammatory reactions to loading in affected tendons exists. The purpose of the present study was to elucidate whether inflammatory signalling responses after acute mechanical loading were more pronounced in tendinopathic versus healthy regions of human tendon and if treatment with non-steroidal anti-inflammatory medications (NSAID's) reduces this response. Twenty-seven tendinopathy patients (>6 months) were randomly assigned to a placebo (n = 14) or NSAID (Ibumetin NYCOMED GmbH Plant Oranienburg Germany (600 mg) × 3/day/1 week) group (n = 13) in a double-blinded-fashion. Tendon biopsies were taken from the painful and a healthy region of the same tendon 2 h after 1 h running. Gene-expression of several targets was analysed in the sampled Achilles tendon biopsies. The mRNA for TGF-ß, collagen-I and collagen-III were significantly higher expressed, and decorin, CTGF, IL-6 and IL-10 were significantly lower expressed in the tendinopathic versus healthy tendon area. Only IL-10 was lower in expression in experiments with NSAID administration, while all other determined parameters were unaffected by NSAID. All ultrasonographic outcomes were unchanged in response to acute exercise and not influenced by NSAID. The signalling for collagen and TGF-beta was upregulated after acute loading in tendinopathic tendon. In contrast to the hypothesis, inflammatory signalling was not exaggerated in tendinopathic tendon 2 h after acute mechanical loading.

Influence of self-efficacy on compliance to workplace exercise.

BACKGROUND: Continuous neck and shoulder pain is a common musculoskeletal complaint. Physical exercise can reduce pain symptoms, but compliance to exercise is a challenge. Exercise-specific self-efficacy has been found to be a predictor of participation in preplanned exercise. Little is known about the influence of exercise-specific self-efficacy on compliance to workplace physical exercise. PURPOSE: To determine the influence of exercise-specific self-efficacy on compliance to specific strength exercises during working hours for laboratory technicians. METHODS: We performed a cluster-randomized controlled trial, including laboratory technicians from two industrial production units in Copenhagen, Denmark. The participants were randomized to supervised specific strength exercises for the neck and shoulder muscles for 20 minutes three times a week (n = 282) or to a reference group (n = 255). The participants answered baseline and follow-up questions regarding self-efficacy and registered all exercises in a diary. RESULTS: Overall compliance to exercises was 45 %. Compliance in company A (private sector) differed significantly between the three self-efficacy groups after 20 weeks. The odds ratio of compliance was 2.37 for moderate versus low self-efficacy, and 2.93 for high versus low self-efficacy. No significant difference was found in company B (public sector) or in the intervention group as a whole. CONCLUSION: We did not find self-efficacy to be a general statistically significant predictor of compliance to exercises during 20 weeks, but found self-efficacy to be a predictor of compliance in a private sector setting. Workplace-specific differences might be present and should be taken into account.

Early coordinated multidisciplinary intervention to prevent sickness absence and labour market exclusion in patients with low back pain: study protocol of a randomized controlled trial.

BACKGROUND: Musculoskeletal disorders account for one third of the long-term absenteeism in Denmark and the number of individuals sick listed for more than four weeks is increasing. Compared to other diagnoses, patients with musculoskeletal diseases, including low back pain, are less likely to return to work after a period of sick leave. It seems that a multidisciplinary intervention, including cooperation between the health sector, the social sector and in the work place, has a positive effect on days off work due to musculoskeletal disorders and particularly low back pain. It is a challenge to coordinate this type of intervention, and the implementation of a return-to-work (RTW)-coordinator is suggested as an effective strategy in this process. The purpose of this paper is to describe the study protocol and present a new type of intervention, where the physiotherapist both has the role as RTW-coordinator and treating the patient. METHODS/DESIGN: A randomized controlled trial (RCT) is currently on-going. The RCT includes 770 patients with low back pain of minimum four weeks who are referred to an outpatient back centre. The study population consists of patients, who are sick-listed or at risk of sick-leave due to LBP. The control group is treated with usual care in a team of a physiotherapist, a chiropractor, a rheumatologist and a social worker employed at the centre. The Intervention group is treated with usual care and in addition intervention of a psychologist, an occupational physician, an ergonomist, a case manager from the municipal sickness benefit office, who has the authority in the actual case concerning sickness benefit payment and contact to the patients employer/work place. The treating physiotherapist is the RTW-coordinator. Outcome will be reported at the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of days off work. Secondary outcomes are disability, pain, and quality of life. The study will follow the recommendations in CONSORT-statement in designing and reporting RCTs. DISCUSSION: This large RCT is testing the effectiveness of a preventive intervention targeting patients on short term sick leave or at risk being sick listed because of low back pain. We have developed a novel multidisciplinary team structure using the treating physiotherapist as the return to work coordinator, and having the case manager from the municipal sickness benefit office participating in team meetings. The study has the potential to contribute to the knowledge about how to target the challenges in the treatment of LBP. The aim is to prevent sickness absence and labour market exclusion--both on the individual level and economic costs at community level. Short term results will be available in 2014.This study is approved by the Danish Regional Ethics Committee (J.nr: H-C-2008-112) and is registered at TRIAL REGISTRATION: ClinicalTrials.gov: NCT01690234.