The MedXFit-study – CrossFit as a workplace health intervention: a one-year, prospective, controlled, longitudinal, intervention study

IntroductionWorkplace health interventions aim to motivate employees toward healthy behaviors to improve fitness and health in the long-term. We investigated whether CrossFit® is an effective training concept to achieve these goals in inactive employees with sedentary occupations.MethodsThe study followed a prospective, controlled intervention design. Employees were invited to participate in intervention group (IG) or control group (CG) on their own preferences. Inclusion criteria were a predominantly sedentary occupation and execution of less than two muscle and/or mobility enhancing training sessions per week at the time of enrolling. The IG did at least two times a week a CrossFit training of 1 h. Mobility, strength, well-being, and back-issues were measured at the beginning, after 6, and 12 months. Participants in the CG were free to choose any other activities offered at the same time (e.g., circuit training, meditation, full body stability training). Adherence, respectively, behavioral change and maintenance qualities were evaluated based on the COM-B system and presence of behavior maintenance motives.Results89 employees were enrolled into the trial, from where 21 dropped out due to external factors (24%). From the remaining participants, 10 out of 39 (26%) in the IG and 1 out of 29 (4%) in the CG stopped for intrinsic reasons, leading to a non-adherence to the intervention of 22 percentage points. Motivation for behavioral change and maintenance in the IG was primarily driven by enhanced physical and psychological capability. Development of physical capability was evident by significant improvements (p < 0.001) in the IG compared to the CG for mobility (d = 3.3), maximal isometric strength (min. d = 1.7, max. d = 2.5), as well as reduction in pain intensity (p = 0.003, r = 0.4) and frequency (p = 0.009, r = 0.35) after 12 months. Significant improvements between the 6-month and the 12-month measurement in mobility and 6 out of 8 strength measures within the IG indicated the effectiveness of CrossFit beyond the beginner phase.ConclusionCrossFit is a motivating training concept that led to long-term health and fitness improvements in inactive employees doing sedentary work and should be given greater consideration in workplace health promotion

PRECYCLE: multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with palbociclib and an aromatase inhibitor or palbociclib and fulvestrant

Background Efficacy and quality of life (QoL) are key criteria for therapy selection in metastatic breast cancer (MBC). In hormone receptor positive (HR +) human epidermal growth factor receptor 2 negative (HER2 −) MBC, addition of targeted oral agents such as everolimus or a cycline-dependent kinase 4/6 (CDK 4/6) inhibitor (e.g., palbociclib, ribociclib, abemaciclib) to endocrine therapy substantially prolongs progression-free survival and in the case of a CDK 4/6i also overall survival. However, the prerequisite is adherence to therapy over the entire course of treatment. However, particularly with new oral drugs, adherence presents a challenge to disease management. In this context, factors influencing adherence include maintaining patients’ satisfaction and early detection/management of side effects. New strategies for continuous support of oncological patients are needed. An eHealth-based platform can help to support therapy management and physician–patient interaction. Methods PreCycle is a multicenter, randomized, phase IV trial in HR + HER2 − MBC. All patients (n = 960) receive the CDK 4/6 inhibitor palbociclib either in first (62.5%) or later line (37.5%) together with endocrine therapy (AI, fulvestrant) according to national guidelines. PreCycle evaluates and compares the time to deterioration (TTD) of QoL in patients supported by eHealth systems with substantially different functionality: CANKADO active vs. inform. CANKADO active is the fully functional CANKADO-based eHealth treatment support system. CANKADO inform is a CANKADO-based eHealth service with a personal login, documentation of daily drug intake, but no further functions. To evaluate QoL, the FACT-B questionnaire is completed at every visit. As little is known about relationships between behavior (e.g., adherence), genetic background, and drug efficacy, the trial includes both patient-reported outcome and biomarker screening for discovery of forecast models for adherence, symptoms, QoL, progression free survival (PFS), and overall survival (OS). Discussion The primary objective of PreCycle is to test the hypothesis of superiority for time to deterioration (TTD) in terms of DQoL = “Deterioration of quality of life” (FACT-G scale) in patients supported by an eHealth therapy management system (CANKADO active) versus in patients merely receiving eHealth-based information (CANKADO inform). EudraCT Number: 2016–004191-2

Evaluating the ability of an artificial-intelligence cloud-based platform designed to provide information prior to locoregional therapy for breast cancer in improving patient's satisfaction with therapy: the CINDERELLA trial

Background: Breast cancer therapy improved significantly, allowing for different surgical approaches for the same disease stage, therefore offering patients different aesthetic outcomes with similar locoregional control. The purpose of the CINDERELLA trial is to evaluate an artificial-intelligence (AI) cloud-based platform (CINDERELLA platform) vs the standard approach for patient education prior to therapy. Methods: A prospective randomized international multicentre trial comparing two methods for patient education prior to therapy. After institutional ethics approval and a written informed consent, patients planned for locoregional treatment will be randomized to the intervention (CINDERELLA platform) or controls. The patients in the intervention arm will use the newly designed web-application (CINDERELLA platform, CINDERELLA APProach) to access the information related to surgery and/or radiotherapy. Using an AI system, the platform will provide the patient with a picture of her own aesthetic outcome resulting from the surgical procedure she chooses, and an objective evaluation of this aesthetic outcome (e.g., good/fair). The control group will have access to the standard approach. The primary objectives of the trial will be i) to examine the differences between the treatment arms with regards to patients' pre-treatment expectations and the final aesthetic outcomes and ii) in the experimental arm only, the agreement of the pre-treatment AI-evaluation (output) and patient's post-therapy self-evaluation. Discussion: The project aims to develop an easy-to-use cost-effective AI-powered tool that improves shared decision-making processes. We assume that the CINDERELLA APProach will lead to higher satisfaction, better psychosocial status, and wellbeing of breast cancer patients, and reduce the need for additional surgeries to improve aesthetic outcome

Determination of caspase-3 activation fails to predict chemosensitivity in primary acute myeloid leukemia blasts

BACKGROUND: Ex-vivo chemosensitivity tests that measure cell death induction may predict treatment outcome and, therefore, represent a powerful instrument for clinical decision making in cancer therapy. Such tests are, however, work intensive and, in the case of the DiSC-assay, require at least four days. Induction of apoptosis is the mode of action of anticancer drugs and should, therefore, result in the induction of caspase activation in cells targeted by anticancer therapy. METHODS: To determine, whether caspase activation can predict the chemosensitivity, we investigated enzyme activation of caspase-3, a key executioner caspase and correlated these data with chemosensitivity profiles of acute myeloid leukemia (AML) blasts. RESULTS: There was, however, no correlation between the ex-vivo chemosensitivity assessed by measuring the overall rates of cell death by use of the DiSC-assay and caspase-3 activation. CONCLUSION: Thus, despite a significant reduction of duration of the assay from four to one day, induction of apoptosis evaluated by capase-3 activity does not seem to be a valid surrogate marker for chemosensitivity

CrossFit Motivates a 41-Year-Old Obese Man to Change His Lifestyle and Achieve Long-Term Health Improvements: A Case Report

The purpose of this case report was to demonstrate how CrossFit (CF) as a workplace health intervention (WHI) led to long-term lifestyle changes and health improvements in an inactive, sedentary individual. Therefore, we analysed the case of a 41-year-old obese man (BMI: 41.3 kg/m2) with elevated blood pressure and poor fitness. To evaluate the factors that facilitated his behavioural change, we collected quantitative and qualitative data (from 2015 to 2022) and analysed it based on the COM-B framework. Given the already great training opportunities at his workplace, we assumed that improvements in capability and motivation led to behavioural change and maintenance. Essential for this behavioural change was the fact that CF combined health-promoting training with intrinsically motivating aspects which are typical for classic sports such as challenge, a feeling of competence, and social interaction. In conjunction with rapid fitness improvements (capability), a positive feedback cycle between capability, motivation, and behaviour developed which enabled physical activity to become habitual. As a result, blood pressure was normalized, BMI (32.9 kg/m2) and resting heart rate decreased (−20 bpm), and mobility (FMS score: +89%), strength (+14 to 71%), and well-being (WHO-5 score: +12%) increased. In conclusion, CF should be considered an effective, efficient, and safe WHI with great potential for behavioural changes and maintenance

Corrected QT Interval (QTc) Diagnostic App for the Oncological Routine: Development Study

BackgroundNumerous antineoplastic drugs such as chemotherapeutics have cardiotoxic side effects and can lead to long QT syndrome (LQTS). When diagnosed and treated in time, the potentially fatal outcomes of LQTS can be prevented. Therefore, regular electrocardiogram (ECG) assessments are critical to ensure patient safety. However, these assessments are associated with patient discomfort and require timely support of the attending oncologist by a cardiologist. ObjectiveThis study aimed to examine whether this approach can be made more efficient and comfortable by a smartphone app (QTc Tracker), supporting single-lead ECG records on site and transferring to a tele-cardiologist for an immediate diagnosis. MethodsTo evaluate the QTc Tracker, it was implemented in 54 cancer centers in Germany. In total, 266 corrected QT interval (QTc) diagnoses of 122 patients were recorded. Moreover, a questionnaire on routine ECG workflow, turnaround time, and satisfaction (1=best, 6=worst) was answered by the centers before and after the implementation of the QTc Tracker. ResultsCompared to the routine ECG workflow, the QTc Tracker enabled a substantial turnaround time reduction of 98% (mean 2.67, 95% CI 1.72-2.67 h) and even further time efficiency in combination with a cardiologic on-call service (mean 12.10, 95% CI 5.67-18.67 min). Additionally, nurses and patients reported higher satisfaction when using the QTc Tracker. In particular, patients’ satisfaction sharply improved from 2.59 (95% CI 2.41-2.88) for the routine ECG workflow to 1.25 (95% CI 0.99-1.51) for the QTc Tracker workflow. ConclusionsThese results reveal a significant improvement regarding reduced turnaround time and increased user satisfaction. Best patient care might be guaranteed as the exposure of patients with an uncontrolled risk of QTc prolongations can be avoided by using the fast and easy QTc Tracker. In particular, as regular side-effect monitoring, the QTc Tracker app promises more convenience for patients and their physicians. Finally, future studies are needed to empirically test the usability and validity of such mobile ECG assessment methods. Trial RegistrationClinicalTrials.gov NCT04055493; https://classic.clinicaltrials.gov/ct2/show/NCT0405549

MedXFit: CrossFit® as a workplace health intervention

Background The MedXFit-study analyzed whether CrossFit® (CF) as a workplace health intervention (WHI) motivates inactive, sedentary employees to long-term training participation in order to improve health and fitness. Method The study followed a prospective, controlled intervention design and was registered on ClinicalTrials.gov with the trial number NCT05109286. Fifty-five and 34 participants in the intervention (IG) and control group (CG) were measured at baseline (t0), 6 months (t1), and 12 months (t2). Civilian and military members of the University of the Bundeswehr Munich (UniBw M) with a predominantly sedentary occupation who performed less than two strength and/or flexibility training sessions per week were included. While the IG attended CF training twice a week for 60 minutes, the CG was free to use the extensive fitness classes and facilities of the UniBw M (including yoga, spinning, aqua fitness) during working hours. Whether CF contributed to long-term behavioral change was determined by training adherence and evaluated based on the COM-B framework. This framework explains the occurrence of a target behavior via interactions between capability, opportunity, and motivation. Additionally, mobility, maximum strength, and well-being (WHO-5) were measured and analyzed for group differences using a mixed ANOVA. Back issues were assessed exploratively and analyzed by Mann-Whitney-U-test. Results Twenty-nine participants of the IG and 28 of the CG completed the study. Dropouts were primarily extrinsically motivated (extrinsic: IG = 16, CG = 5; intrinsic: IG = 10, CG  =1), resulting in a non-adherence of 22%. After 12 months, participants of the IG completed 79.3 (± 19.3) CF training sessions on average. All participants of the IG stated that they would continue training after the study. Although participants benefited from great opportunity, behavioral maintenance was mainly driven by positive interactions between behavior, motivation, and capability. In terms of capability we found significant improvements in mobility (ⴄ² = .61), maximum strength (ⴄ² = .36 to ⴄ² = .62), back problems (pain intensity: r = .4; pain frequency: r = .35), and subjectively perceived movement competence. Conclusion CF proved to be an effective, long-term motivating training concept for inactive, sedentary employees and should be given greater consideration in the context of WHI

MedXFit—Effects of 6 months CrossFit® in sedentary and inactive employees: A prospective, controlled, longitudinal, intervention study

Abstract Background and Aims Sedentary behavior and physical inactivity are associated with musculoskeletal disorders (MSD). Muscle and mobility enhancing training is recommended to promote musculoskeletal fitness and prevent MSD. A functional fitness program emphasizing the importance of musculoskeletal fitness is provided by CrossFit®. However, data from long‐term CrossFit® interventions assessing measures of musculoskeletal fitness in sedentary and inactive individuals does not exist. Methods This prospective, controlled study investigates the effects of 6 months CrossFit® training (2×60 min/week) in inactive adults (in terms of <2 muscle or mobility enhancing training sessions per week) with predominantly sitting or standing occupations. 91 participants were initially assessed, 2 were excluded, 55 self‐selected for intervention (IG), and 34 for the control group (CG). Primary endpoint was a change in mobility (Functional Movement Screen score). Secondary endpoints were changed in strength (maximum isometric strength in kg; Dr. Wolff BackCheck®), and well‐being (WHO‐5 score). Key exploratory endpoints were changes in back‐issue measures (pain intensity, limitation, and frequency). Results 39 participants of IG and 31 of CG completed the evaluation after 6 months. The IG improved significantly more (p < 0.001) compared with the CG in the FMS (η² = 0.58), trunk extension (η² = 0.46), trunk flexion (η² = 0.47), trunk lateral flexion left (η² = 0.41), trunk lateral flexion right (η² = 0.42), upper body push (η² = 0.4), upper body pull (η² = 0.25), hip extension left (η² = 0.18), and hip extension right (η² = 0.4). Change of WHO‐5 scores did not significantly differ between groups (p = 0.55; η² = 0.01). Exploratory analysis of back‐issue data showed a higher decrease for pain intensity, limitation, and frequency in the IG compared with the CG. Conclusion This study proves for the first time within the scope of a prospective, controlled study the broad benefits of CrossFit® in inactive adults doing predominantly sedentary work