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.

Feasibility of Monitoring Patients Who Have Cancer With a Smart T-shirt: Protocol for the OncoSmartShirt Study.

BACKGROUND: Studies have shown that there may be dissimilar perceptions on symptoms or side effects between patients with cancer and health care professionals. This may lead to symptomatic patients notifying the clinic irregularly or not telling the clinic at all. Wearables could help identify symptoms earlier. Patients with low socioeconomic status and less self-awareness of their health may benefit from this. A new design of wearables is a smart t-shirt that, with embedded sensors, provides measurement flows such as electrocardiogram, thoracic and abdominal respiration, and temperature. OBJECTIVE: This study evaluates the feasibility of using a smart t-shirt for home monitoring of biometric sensor data in adolescent and young adult and elderly patients during cancer treatment. METHODS: The OncoSmartShirt study is an explorative study investigating the feasibility of using the Chronolife smart t-shirt during cancer treatment. This smart t-shirt is designed with multiple fully embedded sensors and electrodes that engender 6 different measurement flows continuously. A total of 20 Danish patients with cancer ≥18 years old in antineoplastic treatment at Department of Oncology Rigshospitalet Denmark will be recruited from all cancer wards, whether patients are in curative or palliative care. Of these 20 patients, 10 (50%) will be <39 years old, defined as adolescent and young adult, and 10 (50%) will be patients >65 years old, defined as elderly. Consenting patients will be asked to wear a smart t-shirt daily for 2 weeks during their treatment course. RESULTS: The primary outcome is to determine if it is feasible to wear a smart t-shirt throughout the day (preferably 8 hours per day) for 2 weeks. Inclusion of patients started in March 2022. CONCLUSIONS: The study will assess the feasibility of using the Chronolife smart t-shirt for home monitoring of vital parameters in patients with cancer during their treatment and bring new insights into how wearables and biometric data can be used as part of symptom or side-effect recognition in patients with cancer during treatment, with the aim to increase patients' quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT05235594; https://beta.clinicaltrials.gov/study/NCT05235594. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37626.

Disease self-management in patients with moderate COPD: a thematic analysis.

BACKGROUND: Treatment of patients with moderate chronic obstructive pulmonary disease (COPD) is challenged by the low priority of the disease by patients and general practitioners (GPs) affecting the extent of self-management. The aim of this study was to explore (i) attitudes to COPD self-management in patients with moderate COPD, (ii) perceptions of GP commitment to pulmonary rehabilitation in patients with moderate COPD, and (iii) COPD knowledge in patients with moderate COPD. METHODS: The study had a qualitative design using semi-structured interviews to explore the views of 14 patients diagnosed with moderate COPD. We applied strategic sampling to obtain maximum variation and conducted a thematic analysis of the data. RESULTS: Our main findings were that the degree of COPD self-management was linked to the resources of the informants. Further, the patients experienced that GPs only availed themselves of selected parts of the recommendations for COPD treatment by focusing on medical treatment and smoking cessation rather than physical activity and diet. Many patients lacked knowledge regarding the tolerated level of physical activity and therefore avoided activity increasing their heart rate. Finally, many patients were reluctant to accept the diagnosis because the disease is known to be self-inflicted. CONCLUSION: Our study suggests that patients with moderate COPD need more information, especially regarding the positive effects of physical activity. GPs might need to devote more time to the three main elements of COPD treatment, smoking cessation, medical treatment, and physical activity, to promote self-management and a healthier lifestyle in patients with COPD.

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.

Motivation and Barriers to Maintaining Lifestyle Changes in Patients with Type 2 Diabetes after an Intensive Lifestyle Intervention (The U-TURN Trial): A Longitudinal Qualitative Study.

The purpose of this study was to explore and identify factors that influence motivation for and barriers to adopting and maintaining lifestyle changes in patients with type 2 diabetes, following participation in an intensive multiple-lifestyle intervention. Participants were recruited from the U-TURN trial, a one-year, intensive lifestyle intervention for type 2 diabetes patients. This study was conducted over time; informants were interviewed twice after the trial ended with a six-month interval between interviews. The qualitative data from these individual interviews were analysed using systematic text condensation with an inductive approach. Five themes emerged: Social support and relatedness, Achievement of results, Support from healthcare professionals, Identification with and acceptance of the new lifestyle and Coping with ongoing challenges. These are all important for maintaining lifestyle changes and diabetes self-management. Changing one's lifestyle can be a constant, difficult struggle. For sustainable progress after an intensive intervention, the changes must be adopted and endorsed by patients and co-opted into their social setting. Belonging to an exercise group, confidence in managing the lifestyle adjustments and handling of challenges through continual support and professional diabetes treatment are crucial in maintaining and adhering to the new lifestyle.

Early initiated postoperative rehabilitation enhances quality of life in patients with operable lung cancer: Secondary outcomes from a randomized trial.

INTRODUCTION: Patients with lung cancer report a lower degree of Health Related Quality of Life (HRQoL) compared with other cancer patients. HRQoL reflects how patients experience the impact of their disease and its treatment on their quality of daily living. A widely used questionnaire in lung cancer patients is the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire. Here we report the secondary outcomes on FACT-L data from the Postoperative Rehabilitation in Operation for Lung CAncer (PROLUCA) study, which describes the effect of early (14 days) versus late initiated (14 weeks) postoperative rehabilitation. MATERIALS AND METHODS: The PROLUCA study was designed as a two-armed randomized controlled trial with an early rehabilitation group (14 days after surgery (ERG)) or a control arm with a late rehabilitation group (14 weeks after surgery (LRG)). The results for seven domain scores obtained using the FACT-L at the following time-points: baseline, 14 weeks, 26 weeks and 52 weeks after surgery are presented here. RESULTS: 119 patients were randomized to the ERG and 116 to the LRG. In the ERG, HRQoL measured by both FACT-L and FACT-G (general core instrument) showed a continuous improvement up to 26 weeks after which HRQoL decreased after further 26 weeks without structured intervention. In the LRG a non-significant deterioration was detected over the first 14 weeks after surgery. After participation in the 12 weeks rehabilitation program, an increase in HRQoL was seen, without reaching the same level as the early group. CONCLUSION: Analyses of the seven domain scores obtained using FACT-L and FACT-G reflect the importance of starting exercise early after surgery since the ERG avoid a temporary decrease in HRQoL. It is therefore recommended to start up a structured rehabilitation program 14 days after surgery, containing high intensity interval training and strength exercise twice a week for 12 weeks.

Frailty Index Status of Canadian Home Care Clients Improves With Exercise Therapy and Declines in the Presence of Polypharmacy.

OBJECTIVE: This study aimed to investigate if exercise therapy and polypharmacy was associated with frailty state transitions for home care service recipients. DESIGN: Longitudinal cohort-study using client-level health information collected using interRAI home care (RAI-HC) assessments. SETTING: Population-based study with Canadian home care clients in Alberta, British Columbia, Ontario and the Yukon. PARTICIPANTS: Home care clients aged 65 years and older. METHODS: A Markov chain multistate transition logistic regression model was used to calculate ORs for state transitions with exercise therapy and polypharmacy as independent variables. RESULTS: In total, 250,428 home care clients experiencing 402,005 frailty state transitions were included in the analyses. At baseline, 39.4% of clients were categorized as nonfrail, 30.2% were categorized as prefrail, and 30.4% were categorized as frail. Nonfrail clients using polypharmacy were more likely to become prefrail (OR 1.16) and frail (OR 1.11). Pre-frail clients using polypharmacy were more likely to become frail (OR 1.06), and they were less likely to become nonfrail (OR 0.80). Frail clients using polypharmacy were significantly less likely to become prefrail (OR 0.82) or nonfrail (OR 0.62). Nonfrail clients who participated in exercise therapy were more likely to become prefrail (OR 1.05). Prefrail clients who participated in exercise therapy were more likely to become nonfrail (OR 1.26). Frail clients who participated in exercise therapy were more likely to become nonfrail (OR 1.27) and prefrail (OR 1.12). CONCLUSIONS AND IMPLICATIONS: This study suggests that frailty among home care clients can be reversed. Frailty state improvement occurred significantly more often among home care clients receiving exercise therapy and significantly less often among clients with polypharmacy.

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.

Early initiated postoperative rehabilitation reduces fatigue in patients with operable lung cancer: A randomized trial.

INTRODUCTION: Little is known about the optimal amount and timing of exercise strain in concern of the operation wound and with regard improvement of physical function and quality of life (QOL) after surgery for lung cancer. On this background, we decided to investigate the effect of early vs. late initiated postoperative rehabilitation in patients with operable lung cancer on exercise capacity, functional capacity, muscle strength, and QOL. METHODS: The study was designed as a two-armed randomized controlled trial with randomization to either early initiated postoperative rehabilitation (14 days after surgery (ERG)) or a control arm with late initiated postoperative rehabilitation (14 weeks after surgery (LRG)). The primary endpoint was a change in maximum oxygen consumption (VO2peak) from baseline to post intervention 26 weeks following lung resection. Fatigue was measured with EORTC QLQ C30 LC13. RESULTS: From April 2013 to June 2016, 582 patients with operable NSCLC were screened for eligibility. With 119 patients randomized in the early rehabilitation group (ERG) and 116 randomized to late rehabilitation group (LRG). There was no significant difference from baseline to 26 weeks between ERG and LRG (p = 0.926). There was a significant difference from baseline to 14 weeks between groups (p = 0.0018). There was a significant difference from 14 weeks to 26 weeks between the two groups (p < 0.001). We found no significant differences in QOL but we found a significant difference between ERG and LRG from baseline to 14 weeks in fatigue level in favour of ERG. CONCLUSION: This is the first randomized controlled trial to investigate the effects of early vs. late initiated postoperative rehabilitation in patients with lung cancer. There is no difference in the commencement (early vs. late) of a postoperative exercise program for patients with lung cancer on exercise capacity. But to reduce fatigue patients should be recommended to initiate early exercise programs.

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.

Effect of postsurgical rehabilitation programmes in patients operated for lung cancer: A systematic review and meta-analysis.

OBJECTIVE: To review the evidence concerning the effects of postoperative exercise interventions on exercise capacity and health-related quality of life following resection for non-small cell lung cancer, and to review whether different initiation times of exercise produce different effects on exercise capacity. DATA SOURCES: Comprehensive literature search of MEDLINE, Embase, CENTRAL, CINAHL and PEDro. STUDY SELECTION: Randomized controlled trials examining the effects of exercise interventions were eligible for inclusion. DATA EXTRACTION: Postoperative outcome measurements were extracted and the quality of evidence was graded using Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group. DATA SYNTHESIS: Four randomized controlled trials were identified involving 262 participants. Short-term follow-up (12-20 weeks) showed significantly higher exercise capacity and physical component of health-related quality of life in the intervention group (standardized mean difference (SMD) 0.48; 95% confidence interval (CI) 0.04-0.93) compared with the control group (SMD 0.50; 95% CI 0.19-0.82). There was no difference between the effect of late- and early-initiated exercise intervention. CONCLUSION: Exercise has a small-to-moderate effect at short-term follow-up on exercise capacity and the physical component of health-related quality of life in patients operated for lung cancer. The long-term effects of exercise capacity are unknown. Early-initiated exercise programmes (2 weeks post-operation) did not show an effect on exercise capacity. These findings should be interpreted with caution.

Changes in Health-Related Quality of Life During Rehabilitation in Patients With Operable Lung Cancer: A Feasibility Study (PROLUCA).

INTRODUCTION: Surgical resection in patients with non-small cell lung cancer (NSCLC) may be associated with significant morbidity, functional limitations, and decreased quality of life. OBJECTIVES: The objective is to present health-related quality of life (HRQoL) changes over time before and 1 year after surgery in patients with NSCLC participating in a rehabilitation program. METHODS: Forty patients with NSCLC in disease stage I to IIIa, referred for surgical resection at the Department of Cardiothoracic Surgery RT, Rigshospitalet, were included in the study. The rehabilitation program comprised supervised group exercise program, 2 hours weekly for 12 weeks, combined with individual counseling. The study endpoints were self-reported HRQoL (Functional Assessment of Cancer Therapy-Lung, European Organization for Research and Treatment in Cancer-Quality of Life Questionnaire-QLQ-C30, Short-Form-36) and self-reported distress, anxiety, depression, and social support (National Comprehensive Cancer Network Distress Thermometer, Hospital Anxiety and Depression Scale, Multidimensional Scale of Perceived Social Support), measured presurgery, postintervention, 6 months, and 1 year after surgery. RESULTS: Forty patients were included, 73% of whom completed rehabilitation. Results on emotional well-being ( P < .0001), global quality of life ( P = .0032), and mental health component score ( P = .0004) showed an overall statistically significant improvement during the study. CONCLUSION: This feasibility study demonstrated that global quality of life, mental health, and emotional well-being improved significantly during the study, from time of diagnosis until 1 year after resection, in patients with NSCLC participating in rehabilitation.

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.

Long-term exercise adherence after public health training in at-risk adults.

OBJECTIVES: Sustainment of healthy exercise behavior is essential in preventing cardiovascular disease and diabetes. Few studies have explored long-term exercise adherence after an exercise referral scheme. The objective of this study was to examine 12-month exercise adherence after an exercise intervention program. METHODS: This was a pragmatic follow-up study in at-risk people performed between June 2012 and January 2014. The main outcome measure was self-reported single-item exercise adherence. Secondary outcomes were change in exercise level, quality of life rated on a visual analog scale and self-rated health. Predictors of long-term exercise adherence were assessed by logistic regression, estimating crude odds-ratios (OR) and 95% confidence intervals (95% CIs) and adjusting for age, gender, education, smoking, moderate and vigorous exercise. RESULTS: In total, 214 adults (mean age 58.8±11.97 years, 71% women) participated in the study and received a 12-week training intervention: 62% had hypertension, 64% dyslipidemia and 15% impaired glucose tolerance. Attrition rate was 84% (n=179). During the 12-month follow-up, 48% (n=85) reported long-term exercise adherence. The main predictors of long-term exercise adherence were participation in sport activities at baseline (adjusted odds-ratio [aOR] 4.22, 95% CI 1.72-10.40), self-rated health (aOR 2.60, 1.00-6.75) and quality of life (aOR 2.39, 1.03-5.54). Long-term non-adherence was associated with low education (<10 years; aOR 3.27, 1.14-9.43) and age<50 years (aOR 3.53, 1.32-9.43). CONCLUSIONS: In this pragmatic study, long-term exercise adherence was associated with participation in sport activities and self-rated health at baseline.

Patients' preference for exercise setting and its influence on the health benefits gained from exercise-based cardiac rehabilitation.

OBJECTIVE: To assess patient preference for exercise setting and examine if choice of setting influences the long-term health benefit of exercise-based cardiac rehabilitation. METHODS: Patients participating in a randomised controlled trial following either heart valve surgery, or radiofrequency ablation for atrial fibrillation were given the choice to perform a 12-week exercise programme in either a supervised centre-based, or a self-management home-based setting. Exercise capacity and physical and mental health outcomes were assessed for up to 24months after hospital discharge. Outcomes between settings were compared using a time×setting interaction using a mixed effects regression model. RESULTS: Across the 158 included patients, an equivalent proportion preferred to undertake exercise rehabilitation in a centre-based setting (55%, 95% CI: 45% to 63%) compared to a home-based setting (45%, 95% CI: 37% to 53%, p=0.233). At baseline, those who preferred a home-based setting reported better physical health (mean difference in physical component score: 5.0, 95% CI 2.3 to 7.4; p=0.001) and higher exercise capacity (mean between group difference 15.9watts, 95% CI 3.7 to 28.1; p=0.011). With the exception of the depression score in the Hospital Anxiety and Depression Score (F(3.65), p=0.004), there was no evidence of a significant difference in outcomes between settings. CONCLUSION: The preference of patients to participate in home-based and centre-based exercise programmes appears to be equivalent and provides similar health benefits. Whilst these findings support that patients should be given the choice between exercise-settings when initiating cardiac rehabilitation, further confirmatory evidence is needed.

Is the Cardiovascular Response Equivalent Between a Supervised Center-Based Setting and a Self-care Home-Based Setting When Rating of Perceived Exertion Is Used to Guide Aerobic Exercise Intensity During a Cardiac Rehabilitation Program?

OBJECTIVES: The aim of this study was to investigate if exercise intensity guided by rating of perceived exertion (RPE) results in an equivalent cardiovascular response when applied in either a center-based or a home-based setting. DESIGN: Data from patients with heart disease (post-valve surgery and atrial fibrillation post-radiofrequency ablation) participating in exercise-based rehabilitation were included. Patients performed a 12-week program in either a center- or a home-based setting. Using RPE, patients recorded their exercise intensity 3 times during an aerobic training phase. Exercise intensity was objectively measured using heart rate (HR) monitors. RESULTS: A total of 2622 RPE values with corresponding HR data were available. There was no difference in the level of association (interaction P = 0.51) between HR and RPE seen in the center-based setting (mean of 6.1 beats/min per 1.0 difference in RPE; 95% confidence interval, 4.8-7.5 beats/min) compared with the home-based setting (mean of 5.3 beats/min per 1.0 difference in RPE; 95% confidence interval, 4.0-6.5 beats/min). The level of patient familiarization, exercise intensity, and patient characteristics did not affect the level of association between RPE and HR. CONCLUSIONS: Independent of exercise setting, RPE appears to be equally effective in guiding exercise intensity of patients participating in cardiac rehabilitation.

Perioperative Rehabilitation in Operable Lung Cancer Patients (PROLUCA): A Feasibility Study.

Introduction Surgical resection in patients with non-small cell lung cancer (NSCLC) may be associated with significant morbidity, functional limitations, and decreased quality of life. Objectives The safety and feasibility of a preoperative and early postoperative rehabilitation program in patients operated for NSCLC was determined in a nonhospital setting, with focus on high-intensity interval exercise. Methods Forty patients with biopsy-proven NSCLC stages I to IIIa referred for surgical resection at the Department of Cardiothoracic Surgery RT, Rigshospitalet, University of Copenhagen, were randomly assigned to 1 of 4 groups (3 intervention groups and 1 control group). The preoperative intervention consisted of a home-based exercise program, while the postoperative exercise program comprised a supervised group exercise program involving resistance and high-intensity interval cardiorespiratory exercise 2 hours weekly for 12 weeks combined with individual counseling. The study endpoints were inclusion rate, adherence, and number of adverse events. Results Forty patients (of 124 screened; 32%) were included and randomized into the 4 groups. The postoperative exercise was completed by 73% of the patients randomized to this intervention. No adverse events were observed, indicating that the early postoperative exercise program is safe. The preoperative home-based exercise program was not feasible due to interfering diagnostic procedures and fast-track surgery that left only 1 to 2 weeks between diagnosis and surgery. Conclusion The early postoperative exercise program for patients with NSCLC was safe and feasible, but in a fast-track set up, a preoperative home-based exercise program was not feasible for this population.

Self-rating level of perceived exertion for guiding exercise intensity during a 12-week cardiac rehabilitation programme and the influence of heart rate reducing medication.

OBJECTIVES: To investigate whether self-rating level of perceived exertion can adequately guide exercise intensity during a 12-week cardiac rehabilitation programme. DESIGN: Linear regression analysis using rehabilitation data from two randomised controlled trials. METHODS: Patients undergoing radiofrequency ablation for atrial fibrillation or following heart valve surgery and participating in exercise-based rehabilitation were included. The 12-week rehabilitation outpatient programme comprised three weekly training sessions, each consisting of 20min aerobic exercise divided into three steps. Patients were asked to base their exercise intensity for each step on a predefined rating of perceived exertion specified in a training diary. Exercise intensity was objectively measured by heart rate during the last 2min for each exercise step. Comparative analysis and linear regression of the rating of perceived exertion and heart rate were performed. RESULTS: A total of 2622 ratings of perceived exertion were collected from 874 training sessions in 97 patients. Heart rate and rating of perceived exertion were associated both across all three exercise steps and individually for each step, with a mean of 6 to7bpm per 1-point difference in the rating of perceived exertion (p<0.001). Adjusting for rate-reducing medication slightly improved the strength of the association. CONCLUSIONS: The association between change in the rating of perceived exertion and change in heart rate indicates that a diary-led and self-regulated model using rating of perceived exertion can help guide exercise intensity in everyday clinical practice among patients with heart disease, irrespective if they are taking heart rate-reducing medication.

Head-to-head comparison of intensive lifestyle intervention (U-TURN) versus conventional multifactorial care in patients with type 2 diabetes: protocol and rationale for an assessor-blinded, parallel group and randomised trial.

INTRODUCTION: Current pharmacological therapies in patients with type 2 diabetes (T2D) are challenged by lack of sustainability and borderline firm evidence of real long-term health benefits. Accordingly, lifestyle intervention remains the corner stone in the management of T2D. However, there is a lack of knowledge regarding the optimal intervention programmes in T2D ensuring both compliance as well as long-term health outcomes. Our objective is to assess the effects of an intensive lifestyle intervention (the U-TURN intervention) on glycaemic control in patients with T2D. Our hypothesis is that intensive lifestyle changes are equally effective as standard diabetes care, including pharmacological treatment in maintaining glycaemic control (ie, glycated haemoglobin (HbA1c)) in patients with T2D. Furthermore, we expect that intensive lifestyle changes will decrease the need for antidiabetic medications. METHODS AND ANALYSIS: The study is an assessor-blinded, parallel group and a 1-year randomised trial. The primary outcome is change in glycaemic control (HbA1c), with the key secondary outcome being reductions in antidiabetic medication. Participants will be patients with T2D (T2D duration <10 years) without complications who are randomised into an intensive lifestyle intervention (U-TURN) or a standard care intervention in a 2:1 fashion. Both groups will be exposed to the same standardised, blinded, target-driven pharmacological treatment and can thus maintain, increase, reduce or discontinue the pharmacological treatment. The decision is based on the standardised algorithm. The U-TURN intervention consists of increased training and basal physical activity level, and an antidiabetic diet including an intended weight loss. The standard care group as well as the U-TURN group is offered individual diabetes management counselling on top of the pharmacological treatment. ETHICS AND DISSEMINATION: This study has been approved by the Scientific Ethical Committee at the Capital Region of Denmark (H-1-2014-114). Positive, negative or inconclusive findings will be disseminated in peer-reviewed journals, at national and international conferences. TRIAL REGISTRATION NUMBER: NCT02417012.

Inflammatory and Metabolic Alterations of Kager's Fat Pad in Chronic Achilles Tendinopathy.

BACKGROUND: Achilles tendinopathy is a painful inflammatory condition characterized by swelling, stiffness and reduced function of the Achilles tendon. Kager's fat pad is an adipose tissue located in the area anterior to the Achilles tendon. Observations reveal a close physical interplay between Kager's fat pad and its surrounding structures during movement of the ankle, suggesting that Kager's fat pad may stabilize and protect the mechanical function of the ankle joint. AIM: The aim of this study was to characterize whether Achilles tendinopathy was accompanied by changes in expression of inflammatory markers and metabolic enzymes in Kager's fat pad. METHODS: A biopsy was taken from Kager's fat pad from 31 patients with chronic Achilles tendinopathy and from 13 healthy individuals. Gene expression was measured by reverse transcription-quantitative PCR. Focus was on genes related to inflammation and lipid metabolism. RESULTS: Expression of the majority of analyzed inflammatory marker genes was increased in patients with Achilles tendinopathy compared to that in healthy controls. Expression patterns of the patient group were consistent with reduced lipolysis and increased fatty acid ß-oxidation. In the fat pad, the pain-signaling neuropeptide substance P was found to be present in one third of the subjects in the Achilles tendinopathy group but in none of the healthy controls. CONCLUSION: Gene expression changes in Achilles tendinopathy patient samples were consistent with Kager's fat pad being more inflamed than in the healthy control group. Additionally, the results indicate an altered lipid metabolism in Kager's fat pad of Achilles tendinopathy patients.