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.

The Effects of a Lifestyle Intervention Supported by the InterWalk Smartphone App on Increasing Physical Activity Among Persons With Type 2 Diabetes: Parallel-Group, Randomized Trial.

BACKGROUND: Effective and sustainable implementation of physical activity (PA) in type 2 diabetes (T2D) health care has in general not been successful. Efficacious and contemporary approaches to support PA adherence and adoption are required. OBJECTIVE: The primary objective of this study was to investigate the effectiveness of including an app-based (InterWalk) approach in municipality-based rehabilitation to increase moderate-and-vigorous PA (MVPA) across 52 weeks compared with standard care among individuals with T2D. METHODS: The study was designed as a parallel-group, randomized trial with 52 weeks' intervention and subsequent follow-up for effectiveness (52 weeks from baseline). Participants were recruited between January 2015 and December 2016 and randomly allocated (2:1) into 12 weeks of (1) standard care + InterWalk app-based interval walking training (IWT; IWT group; n=140), or (2) standard care + the standard exercise program (StC group; n=74). Following 12 weeks, the IWT group was encouraged to maintain InterWalk app-based IWT (3 times per week for 30-60 minutes) and the StC group was encouraged to maintain exercise without structured support. Moreover, half of the IWT group (IWTsupport group, n=54) received additional motivational support following the 12-week program until 52-week follow-up. The primary outcome was change in objectively measured MVPA time (minutes/day) from baseline to 52-week follow-up. Key secondary outcomes included changes in self-rated physical and mental health-related quality of life (HRQoL), physical fitness, weight, and waist circumference. RESULTS: Participants had a mean age of 59.6 (SD 10.6) years and 128/214 (59.8%) were men. No changes in MVPA time were observed from baseline to 52-week follow-up in the StC and IWT groups (least squares means [95% CI] 0.6 [-4.6 to 5.8] and -0.2 [-3.8 to 3.3], respectively) and no differences were observed between the groups (mean difference [95% CI] -0.8 [-8.1 to 6.4] minutes/day; P=.82). Physical HRQoL increased by a mean of 4.3 (95% CI 1.8 to 6.9) 12-item Short-Form Health Survey (SF-12) points more in the IWT group compared with the StC group (Benjamini-Hochberg adjusted P=.007) and waist circumference apparently decreased a mean of -2.3 (95% CI -4.1 to -0.4) cm more in the IWT group compared with the StC group but with a Benjamini-Hochberg adjusted P=.06. No between-group differences were observed among the remaining key secondary outcomes. CONCLUSIONS: Among individuals with T2D referred to municipality-based lifestyle programs, randomization to InterWalk app-based IWT did not increase objectively measured MVPA time over 52 weeks compared with standard health care, although apparent benefits were observed for physical HRQoL. TRIAL REGISTRATION: ClinicalTrials.gov NCT02341690; https://clinicaltrials.gov/ct2/show/NCT02341690.

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.

Effectiveness of physical activity monitors in adults: systematic review and meta-analysis.

OBJECTIVE: To estimate the effectiveness of physical activity monitor (PAM) based interventions among adults and explore reasons for the heterogeneity. DESIGN: Systematic review and meta-analysis. STUDY SELECTION: The electronic databases MEDLINE, Embase, SPORTDiscus, CINAHL, and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched on 4 June 2021. Eligible randomised controlled trials compared interventions in which adults received feedback from PAMs with control interventions in which no feedback was provided. No restrictions on type of outcome measurement, publication date, or language were applied. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted data and assessed risk of bias. Random effects meta-analyses were used to synthesise the results. The certainty of evidence was rated by the Grading of Recommendations Assessment and Evaluation (GRADE) approach. MAIN OUTCOME MEASURES: The three primary outcomes of interest were physical activity, moderate to vigorous physical activity, and sedentary time. RESULTS: 121 randomised controlled trials with 141 study comparisons, including 16 743 participants, were included. The PAM based interventions showed a moderate effect (standardised mean difference 0.42, 95% confidence interval 0.28 to 0.55) on physical activity, equivalent to 1235 daily steps; a small effect (0.23, 0.16 to 0.30) on moderate to vigorous physical activity, equivalent to 48.5 weekly minutes; and a small insignificant effect (-0.12, -0.25 to 0.01) on sedentary time, equal to 9.9 daily minutes. All outcomes favoured the PAM interventions. CONCLUSIONS: The certainty of evidence was low for the effect of PAM based interventions on physical activity and moderate for moderate to vigorous physical activity and sedentary time. PAM based interventions are safe and effectively increase physical activity and moderate to vigorous physical activity. The effect on physical activity and moderate to vigorous physical activity is well established but might be overestimated owing to publication bias. STUDY REGISTRATION: PROSPERO CRD42018102719.

The MIPAM trial - motivational interviewing and physical activity monitoring to enhance the daily level of physical activity among older adults - a randomized controlled trial.

BACKGROUND: One in four older adults in Denmark and almost half of the very old above 75 do not meet the World Health Organization's recommendations for a minimum of physical activity (PA). A cost-efficient and effective way to increase focus on and motivation for daily walking might be to use Physical Activity Monitors (PAMs) in combination with behavioural change intervention. Thus, the objective of this randomized controlled study was to investigate the effect of Motivational Interviewing (MI) as an add-on intervention to a PAM-based intervention measured in community-dwelling older adults. METHODS: This two-arm parallel group randomized controlled effectiveness trial compared a 12-weeks PAM-based intervention with additional MI (PAM+MI group) with a PAM-based intervention alone (PAM group). The primary outcome, average daily step count, was analysed with a linear regression model, adjusted for sex and baseline daily step count. Following the intention-to-treat principle, multiple imputation based on baseline step count, sex and age was performed. RESULTS: In total, 38 participants were randomized to the PAM intervention and 32 to the PAM+MI intervention arm. During the intervention period, PAM+MI participants walked on average 909 more steps per day than PAM participants, however insignificant (95%CI: - 71; 1889) and reported 2.3 points less on the UCLA Loneliness Scale (95%CI: - 4.5; - 1.24). CONCLUSION: The use of MI, in addition to a PAM-based intervention among older adults in PA promoting interventions hold a potential clinically relevant effect on physical activity and should thus be investigated further with adequately powered RCTs. TRIAL REGISTRATION: This study was pre-registered in the clinicaltrials.gov database with identifier: NCT03906162 .

One-year intensive lifestyle intervention and improvements in health-related quality of life and mental health in persons with type 2 diabetes: a secondary analysis of the U-TURN randomized controlled trial.

INTRODUCTION: The effects of lifestyle interventions in persons with type 2 diabetes (T2D) on health-related quality of life (HRQoL) and subjective well-being are ambiguous, and no studies have explored the effect of exercise interventions that meet or exceed current recommended exercise levels. We investigated whether a 1-year intensive lifestyle intervention is superior in improving HRQoL compared with standard care in T2D persons. RESEARCH DESIGN AND METHODS: We performed secondary analyses of a previously conducted randomized controlled trial (April 2015 to August 2016). Persons with non-insulin-dependent T2D (duration ≤10 years) were randomized to 1-year supervised exercise and individualized dietary counseling (ie, 'U-TURN'), or standard care. The primary HRQoL outcome was change in the 36-item Short Form Health Survey (SF-36) physical component score (PCS) from baseline to 12 months of follow-up, and a key secondary outcome was changes in the SF-36 mental component score (MCS). RESULTS: We included 98 participants (U-TURN group=64, standard care group=34) with a mean age of 54.6 years (SD 8.9). Between-group analyses at 12-month follow-up showed SF-36 PCS change of 0.8 (95% CI -0.7 to 2.3) in the U-TURN group and deterioration of 2.4 (95% CI -4.6 to -0.1) in the standard care group (difference of 3.2, 95% CI 0.5 to 5.9, p=0.02) while no changes were detected in SF-36 MCS. At 12 months, 19 participants (30%) in the U-TURN group and 6 participants (18%) in the standard care group achieved clinically significant improvement in SF-36 PCS score (adjusted risk ratio 2.6, 95% CI 1.0 to 4.5 corresponding to number needed to treat of 4, 95% CI 1.6 to infinite). CONCLUSION: In persons with T2D diagnosed for less than 10 years, intensive lifestyle intervention improved the physical component of HRQoL, but not the mental component of HRQoL after 1 year, compared with standard care. TRIAL REGISTRATION NUMBER: NCT02417012.

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.

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.

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.

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.

Effect of Platelet-Rich Plasma on Nonsurgically Treated Acute Achilles Tendon Ruptures: A Randomized, Double-Blinded Prospective Study.

BACKGROUND: An acute Achilles tendon rupture (ATR) is a long-lasting and devastating injury. Possible biological augmentation to promote and strengthen tendon healing after an ATR would be desirable. PURPOSE: To determine whether the application of a platelet-rich plasma (PRP) injection in nonsurgically treated ATRs may promote healing and thereby improve functional outcomes. STUDY DESIGN: Randomized controlled trial; Level of evidence, 2. METHODS: A total of 40 men (aged 18-60 years) with an ATR incurred within 72 hours were included, and 38 were followed for 12 months. All patients were treated with an orthosis with 3 wedges for 8 weeks; full weightbearing from day 1 was allowed, combined with either 4 PRP or 4 placebo injections (a few drops of saline, <0.5 mL, under the skin) 14 days apart. All patients received the same instructions on an exercise program starting from week 9. Outcomes included the self-reported Achilles tendon Total Rupture Score (ATRS) as well as heel-rise work, heel-rise height, tendon elongation, calf circumference, and ankle dorsiflexion range of motion. RESULTS: The mean ATRS score improved in both groups at all time points (P < .001), but there was no difference between the groups at any time points (12 months: 90.1 points in PRP group and 88.8 points in placebo group). No differences in all functional outcomes at any time points were seen between the groups. At 12 months, the injured leg did not reach normal functional values compared with the uninjured leg. CONCLUSION: The application of PRP in nonsurgically treated ATRs did not appear to show any superior clinical and functional improvement. REGISTRATION: NCT02417922 (ClinicalTrials.gov identifier).

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.

Injuries in Novice Participants during an Eight-Week Start up CrossFit Program-A Prospective Cohort Study.

BACKGROUND: Previously published studies have reported injury rates ranging from 0.74 to 3.3 per 1000 h of exposure in CrossFit participants. However, the existing body of evidence is mainly based on experienced participants; therefore, the injury incidence and injury rate within novice CrossFit participants remains relatively unknown. The aim of this study wasto investigate the injury incidence and injury rate among novice participants in an eight-week CrossFit program. METHODS: This survey-based prospective cohort study included CrossFit Copenhagen's novice members who began an eight-week, free-of-charge membership period. A questionnaire was distributed at baseline and at eight-week follow-up. Information about exposure was retrieved through the online booking system. Injury incidence, defined as proportion of participants who sustained an injury, and injury rates per 1000 h of exposure were calculated. RESULTS: Among the 168 included participants, a total of 28 injuries (14.9%) were reported. The number of injured participants and total exposure time resulted in an injury rate per 1000 h of exposure of 9.5. CONCLUSIONS: Compared to the existing body of evidence, the findings in this study indicate that the risk of injuries is higher among novice participants than among experienced CrossFit participants.

Dose-Response Effects of Exercise on Glucose-Lowering Medications for Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial.

OBJECTIVE: To investigate whether a dose-response relationship exists between volume of exercise and discontinuation of glucose-lowering medication treatment in patients with type 2 diabetes. PATIENTS AND METHODS: Secondary analyses of a randomized controlled exercise-based lifestyle intervention trial (April 29, 2015 to August 17, 2016). Patients with non-insulin-dependent type 2 diabetes were randomly assigned to an intensive lifestyle intervention (U-TURN) or standard-care group. Both groups received lifestyle advice and objective target-driven medical regulation. Additionally, the U-TURN group received supervised exercise and individualized dietary counseling. Of the 98 randomly assigned participants, 92 were included in the analysis (U-TURN, n=61, standard care, n=31). Participants in the U-TURN group were stratified into tertiles based on accumulated volumes of exercise completed during the 1-year intervention. RESULTS: Median exercise levels of 178 (interquartile range [IQR], 121-213; lower tertile), 296 (IQR, 261-310; intermediate tertile), and 380 minutes per week (IQR, 355-446; upper tertile) were associated with higher odds of discontinuing treatment with glucose-lowering medication, with corresponding odds ratios of 12.1 (95% CI, 1.2-119; number needed to treat: 4), 30.2 (95% CI, 2.9-318.5; 3), and 34.4 (95% CI, 4.1-290.1; 2), respectively, when comparing with standard care. Cardiovascular risk factors such as glycated hemoglobin A1c levels, fitness, 2-hour glucose levels, and triglyceride levels were improved significantly in the intermediate and upper tertiles, but not the lower tertile, compared with the standard-care group. CONCLUSION: Exercise volume is associated with discontinuation of glucose-lowering medication treatment in a dose-dependent manner, as are important cardiovascular risk factors in well-treated participants with type 2 diabetes and disease duration less than 10 years. Further studies are needed to support these findings. STUDY REGISTRATION: ClinicalTrials.gov registration (NCT02417012).

Criterion validity for step counting in four consumer-grade physical activity monitors among older adults with and without rollators.

BACKGROUND: Few studies have investigated the measurement properties of consumer-grade physical activity monitors (PAMs) in older adults. Therefore, we investigated the criterion validity of consumer-grade PAMs in older adults and whether the measurement properties differed between older adults with and without rollators and whether worn on the hip or at the wrist. METHODS: Consumer-grade PAMs were eligible for inclusion in this study if they: 1) could be fastened at the hip as well as on the wrist, 2) were simple in function and design and thus easy to use for participants with minimal technical skills, 3) included step-counting as outcome measure and 4) were powered by a button cell battery. Participants performed self-paced walking for six minutes while two physiotherapists counted their steps with a click-counter. The average of the two counts was used as criterion. The participants wore 16 monitors, four located bilaterally on both hips and wrists. Our prior expectation was that all monitors would have at least moderate criterion validity for all participants, good criterion validity for participants walking without a rollator and poor criterion validity for participants walking with a rollator. RESULTS: Four physical activity monitors were included in this study; Misfit Shine, Nokia GO, Jawbone UP Move and Garmin Vivofit 3. A total of 103 older adults participated.Nokia GO was excluded from this study due to technical issues. Therefore, we present results on the frequency of data loss, ICC (1, 2) and percentage measurement error for Misfit Shine, Garmin Vivofit 3 and Jawbone UP Move located on four different positions. CONCLUSIONS: The hip-worn PAMs did not differ significantly in terms of measurement error or criterion validity. Wrist-worn monitors cannot adequately measure number of steps in a population of older adults using rollators. The hip-worn PAMs were superior to wrist-worn PAMs among older adults with and without rollators.

Influence of Oral Contraceptive Use on Adaptations to Resistance Training.

Introduction: The majority of young women use oral contraceptives (OCs). Use of OCs has been associated with lower myofibrillar protein and tendon collagen synthesis rates, but it is unknown whether OCs will limit the adaptive response of myotendinous tissue to resistance training. Design and Methods: Fourteen healthy untrained young regular OC users (24 ± 1 years, fat% 32 ± 1, 35 ± 2 ml⋅min-1⋅kg-1) and 14 NOC users (non-OC, controls) (24 ± 1 years, fat% 32 ± 2, 34 ± 2 ml⋅min-1⋅kg-1) performed a 10-week supervised lower extremity progressive resistance training program. Before and after the intervention biopsies from the vastus lateralis muscle and the patellar tendon were obtained. Muscle (quadriceps) and tendon cross-sectional area (CSA) was determined by magnetic resonance imaging (MRI) scans, and muscle fiber CSA was determined by histochemistry. Maximal isometric knee extension strength was assessed by dynamometry while 1 repetition maximum (RM) was determined during knee extension. Results: Training enhanced CSA in both muscle (p < 0.001) and tendon (p < 0.01). A trend toward a greater increase in muscle CSA was observed for OC (11%) compared to NOC (8%) (interaction p = 0.06). Analysis of mean muscle fiber type CSA showed a trend toward an increase in type II muscle fiber area in both groups (p = 0.11, interaction p = 0.98), whereas type I muscle fiber CSA increased in the OC group (n = 9, 3821 ± 197 to 4490 ± 313 mm2, p < 0.05), but not in NOC (n = 7, 4020 ± 348 to 3777 ± 354 mm2, p = 0.40) (interaction p < 0.05). Post hoc analyses indicated that the effect of OCs on muscle mass increase was induced by the OC-users (n = 7), who used OCs containing 30 µg ethinyl estradiol (EE), whereas the response in users taking OCs with 20 µg EE (n = 7) did not differ from NOC. Both the OC and NOC group experienced an increase in maximal knee strength (p < 0.001) and 1RM leg extension (p < 0.001) after the training period with no difference between groups. Conclusion: Use of OCs during a 10-week supervised progressive resistance training program was associated with a trend toward a greater increase in muscle mass and a significantly greater increase in type I muscle fiber area compared to controls. Yet, use of OCs did not influence the overall increase in muscle strength related to training.

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.