Due to the documented benefits of peripheral resistance training (RT) and inspiratory resistance training, known as inspiratory muscle training (IMT), in patients with cardiovascular disease, both exercise forms are regularly used in cardiac rehabilitation. However, little is known about the haemodynamic responses to different intensities of dynamic RT, isometric RT, and IMT in patients with coronary artery disease (CAD). This study is designed to evaluate and compare the acute haemodynamic responses elicited by different RT and IMT modalities in patients with CAD.

This study design is a prospective, single-centre, randomised crossover trial. A total of 20 participants with CAD will be included. All participants will undergo four different exercise training interventions: IMT, isometric wall squat training (IWS), dynamic leg press training (DLP) and isometric handgrip training (IHG). For each intervention, participants will perform two intensity modalities in randomised order: IMT (low vs high), IWS (low vs moderate), DLP (low vs high) and IHG (low vs moderate). The primary outcomes are the acute exercise-induced haemodynamic responses (esp. systolic blood pressure, pulse rate, stroke volume, cardiac output) across the different exercise training interventions, as well as the changes in haemodynamic responses during the recovery phase for each intervention. Secondary outcomes include changes in tissue oxygen saturation, oxygen saturation, and perceived dyspnoea and exertion. The study period is planned for 2025.

The study has been approved by the Ethics Committee of the German Sport University Cologne (Ethical Approval Code: 209/24). The findings will be disseminated through international peer-reviewed publications. This study is supported by the Alexander von Humboldt Foundation via the partnership with the Coordenacão de Aperfeicoamento de Pessoal de Nível Superior (CAPES)(CAPES-Humboldt Research Fellowship for Experienced Researchers) and by research funding from Edwards Lifesciences LLC (Limited Liability Company).

German Clinical Trials Register DRKS00035668.

Obesity is a leading risk factor for global morbidity and mortality, associated with significant healthcare costs that exceed US$260 billion annually in the USA. Weight cycling, the repeated pattern of intentional weight loss followed by unintentional regain, can exacerbate obesity-related health complications. This study aimed to assess the health economic consequences of weight cycling in patients with obesity defined by a body mass index (BMI) ≥30 kg/m², comparing ‘weight cyclers’ with ‘non-cyclers’, and evaluating the impact of a high-protein oral nutritional supplement (HP-ONS) as a maintenance strategy following weight loss via glucagon-like peptide-1 receptor agonists (GLP-1RAs).

Lifetime state transition modelling study with monthly cycles to simulate obesity-associated disease progression.

US healthcare system; societal perspective.

Simulated cohort of adult patients with obesity (BMI ≥30 kg/m²), stratified by weight cycling status.

Weight loss via GLP-1RAs with or without HP-ONS for weight maintenance.

Key outcomes included costs per obesity-related event avoided, life years (LYs) gained and quality-adjusted life years (QALYs) gained, calculated from a US societal perspective. Transition probabilities for disease states were derived from meta-analyses and adjusted for weight cycling and other relevant risks. Costs and health utilities were based on published US studies with future costs discounted at 3% per year. Uncertainty was investigated by deterministic and probabilistic sensitivity analyses.

Non-cyclers experienced 0.090 fewer obesity-associated events, gained 0.602 LYs and achieved 0.518 QALYs compared with cyclers, resulting in total cost savings of approximately US$4592 per patient. In the second scenario, the combination of GLP-1RA treatment and HP-ONS for weight maintenance yielded effective health outcomes with a cost-effectiveness ratio of US$24 276 per QALY gained, well within accepted cost-effectiveness thresholds in the USA, ranging from US$100 000 to US$150 000 per QALY gained.

Weight cycling significantly impacts health and economic outcomes for patients with obesity, underscoring the need for effective weight management programmes, including the use of HP-ONS focused on sustained weight maintenance after weight loss to curtail associated risks and costs.

Alliance ruptures constitute a high risk of premature treatment termination and poor psychotherapy outcome. The Alliance-Focused Training (AFT) is a promising transtheoretical approach to enhance therapists’ skills in dealing with alliance ruptures.

To evaluate the effectiveness of Modified AFT with doubling (MAFT-D), a randomised, patient and evaluator-blinded, multicentre trial was designed comparing MAFT-D (delivered to trainee therapists and supervisors) and psychotherapy training/treatment as usual (TAU) for therapists (n=120) and their patients with depressive disorders (n=240). A total of 17 cooperating centres, each offering either cognitive-behavioural or psychodynamic psychotherapy training, will contribute to recruitment. Stratification by centre (both for therapists and patients) and hence therapeutic approach (cognitive-behavioural vs psychodynamic psychotherapies), and by comorbid personality disorder (yes vs no, for patients) will be carried out. The two hierarchically ordered primary hypotheses are: In MAFT-D compared with TAU, a stronger reduction of depressive symptoms and a lower rate of patient dropout is expected from baseline to 20 weeks after baseline. Follow-up assessments are planned at 35 weeks, 20 months and 36 months postbaseline to evaluate the persistence of effects. Secondary patient-related and therapist-related outcomes as well as predictors, moderators and mediators of change will be investigated. Mixed models with repeated measures will be used for the primary analyses.

Ethical approvals were obtained by the institutional ethics review board of the main study centre as well as by review boards in each federal state where one or more cooperating centres are located (secondary votes). Following the Consolidated Standards of Reporting Trials statement for non-pharmacological trials, results will be reported in peer-reviewed scientific journals and disseminated to patient organisations and media.

DRKS00014842; https://drks.de/search/de/trial/DRKS00014842.