C25 C20 C16 C15
Conditions
Interventions
Group 1: Professionally supervised physical prehabilitation in patients undergoing neoadjuvant therapy followed by oncological surgery
Sponsors
JLU Gießen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Physical training possible, logistics feasible
Exclusion criteria
Exclusion criteria: Training sessions not feasible due to logistical or physical reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VO2peak: Changes in the V02peak values (spiroergometry) from the time of recruitment till 3±2nd preoperative day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. General Outcomes - Patient characteristics - Laboratory and clinical routine parameters - Length of hospital stay - Comorbidities / risk calculation 2. Sports Therapy and Exercise Physiology Outcomes - Drop-out rate, participant compliance (feasibility of the study) - Recruitment rate ([number of patients meeting inclusion criteria] / [recruited patients]) - Compliance / drop-out rate ([recruited patients] / [patients who completed the program]) - Adherence rate ([number of planned training sessions] / [completed training sessions]) - Reasons for drop-out / non-participation - Maximum strength - Training volume and intensity - Assessment of physical activity (self-reported International Physical Activity Questionnaire [IPAQ]) “Fitness watches” upon inclusion (physical activity, heart rate variability) - 6-minute walk distance - Cardiopulmonary exercise testing - Bioelectrical impedance analysis (Instrumental) Activities of daily living (ADL) - Composition of T-cell subpopulations, T-cell function (mitochondrial respiration, proliferation, activation, measurement of immunosenescence markers and inflammatory surface markers using flow cytometry) - Measurement of a panel of inflammatory serum cytokines before and after prehabilitation using multiplex ELISA 3. Surgical-Anesthesiological Outcomes - Perioperative hemodynamics & catecholamine requirement (PICCO monitoring instead of arterial blood pressure measurement as part of standard care), determination of mean arterial pressure - Duration and characteristics of surgery - Cardiac and pulmonary function tests (transthoracic echocardiogram and lung function) - Postoperative complication rate (according to Clavien-Dindo classification), Comprehensive Complication Index, surgical site infections according to WHO - Length of stay in intensive care unit, duration of ventilation, need for analgesics (PCA pump, VAS assessment), organ replacement therapy, Horowitz index, fluid volume - Postopera | — |
Countries
Germany
Contacts
Public ContactMartin;Jacqueline Reichert;Braun
Uniklinikum Gießen;Universitätsklinikum Gießen, Klinik für Allgemein-, Viszeral-, Thorax- und Transplantationschrirugie
Outcome results
None listed