Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial.

BACKGROUND: Previous studies have demonstrated the efficacy of rehabilitation after a cardiovascular procedure. Especially older and multimorbid patients benefit from rehabilitation after a cardiac procedure. Prehabilitation prior to cardiac procedures may also have positive effects on patients' pre- and postoperative outcomes. Results of a current meta-analysis show that prehabilitation prior to cardiac procedures can improve perioperative outcomes and alleviate adverse effects. Germany currently lacks a structured cardiac prehabilitation program for older patients, which is coordinated across healthcare sectors. METHODS: In a randomized, controlled, two-arm parallel group, assessor-blinded multicenter intervention trial (PRECOVERY), we will randomize 422 patients aged 75 years or older scheduled for an elective cardiac procedure (e.g., coronary artery bypass graft surgery or transcatheter aortic valve replacement). In PRECOVERY, patients randomized to the intervention group participate in a 2-week multimodal prehabilitation intervention conducted in selected cardiac-specific rehabilitation facilities. The multimodal prehabilitation includes seven modules: exercise therapy, occupational therapy, cognitive training, psychosocial intervention, disease-specific education, education with relatives, and nutritional intervention. Participants in the control group receive standard medical care. The co-primary outcomes are quality of life (QoL) and mortality after 12 months. QoL will be measured by the EuroQol 5-dimensional questionnaire (EQ-5D-5L). A health economic evaluation using health insurance data will measure cost-effectiveness. A mixed-methods process evaluation will accompany the randomized, controlled trial to evaluate dose, reach, fidelity and adaptions of the intervention. DISCUSSION: In this study, we investigate whether a tailored prehabilitation program can improve long-term survival, QoL and functional capacity. Additionally, we will analyze whether the intervention is cost-effective. This is the largest cardiac prehabilitation trial targeting the wide implementation of a new form of care for geriatric cardiac patients. TRIAL REGISTRATION: German Clinical Trials Register (DRKS; http://www.drks.de ; DRKS00030526). Registered on 30 January 2023.

[Rehab Aftercare 'New Credo' in the Cardiac Follow-Up Rehabilitation]. / Nachsorge 'Neues Credo' in der kardiologischen Anschlussrehabilitation.

PURPOSE: Physical inactivity is considered the most important modifiable risk factor of cardio-vascular diseases. Therefore medical rehabilitation is focused on the improvement of physical activity. To maintain physical activity after rehabilitation aftercare strategies are necessary which help to transfer the skills learned during rehabilitation into daily routine. In this study the aftercare concept "Neues Credo" which has been evaluated several times has been implemented and evaluated into cardiological follow-up rehabilitation. METHODS: Prospective, controlled, multicentre study with 4 cardiological rehabilitation institutions. INCLUSION CRITERIA: rehabilitants with initial diagnosis from the ICD groups I20-25 and I34-43. In the first phase of the study, patients received standard rehabilitation and standard aftercare (control group (KG)). In the second phase, patients received rehabilitation based on the conditions of "Neues Credo" with the focus on increasing physical activity (intervention group (IG)). Data for evaluation were collected by paper-and-pencil questionnaires at 3 points in time. Primary outcome variable: restriction in participation (IMET); secondary outcome variables: depression (CES-D), several scales of subjective health and physical activity. Analysis of variance with repeated measures was used for the evaluation of long-term effects. RESULTS: Complete data could be evaluated from 152 patients of the IG and from 165 patients of the KG. At the end of rehabilitation both IG and KG showed improvements in outcome variables. In the period after rehabilitation patients in the IG improved their physical activity significantly more often than members of the KG (66 vs. 42%, p<0,01), they showed more physical activity than the KG (p=0,040) and they performed endurance sports more often (58 vs. 38%, p<0,01). The primary outcome of participation shows significant improvements in both groups (p<0,01) 12 months after the rehabilitation, difference between groups did not reach statistical significance but indicated a clear tendency in favour of the IG. Similar trends could be found for the secondary outcome-data CONCLUSION: In this study, the "Neues Credo" was applied and evaluated in cardiologic rehabilitation for the first time. Participants reported high practicability and high satisfaction. Health- related outcomes show a trend of positive effects in favour of the IG, but the interaction effects did not reach statistical significance in most cases. Regarding physical activity the intervention group shows clear advantage and will probably benefit from the long-term effects of regular endurance training.

Supervised training with wireless monitoring of ECG, blood pressure and oxygen-saturation in cardiac patients.

We have developed a tele-rehabilitation application for training cardiac patients. It uses a modified ergometer bicycle with a set of wireless sensors. While the patient is exercising, the ECG, blood pressure and oxygen-saturation are monitored constantly and automatically. If sensor values exceed pre-defined thresholds, the patient receives an alarm. As a result the training will either be stopped or continued at a reduced load, depending on the severity of the alarm. To measure user acceptance, we introduced the system to 13 members of staff and four patients, who trained on the system every day during their stay in hospital. A total of 39 training sessions were completed. In 27% of the exercise sessions an ECG connection could not be established and in 23%, blood pressure measurement failed. However, there were no failures to measure oxygen saturation. The overall acceptance of the patient's graphical user interface (GUI) was excellent. The doctor's GUI with its functions received an overall score of 1.5 on a scale of 1 to 4 (usefulness 1.6, usability 1.3 and operability 1.6). The SAPHIRE tele-rehabilitation system operated properly and was well accepted by patients and doctors.