Early Remote Rehabilitation to Improve Health of the Elderly After Cardiac Surgery. (RECARD Trial)

Hypotheses:

Primary: Early mobile health intervention at home supplemented by weekly calls from a physiotherapist after cardiac surgery improves functional outcomes, exercise tolerance, and quality of life in older patients.

Secondary:

* Cardiac surgery increases the prevalence and extent of sarcopenia in the elderly which can be mitigated by early mobile health intervention * Sarcopenia on Chest Computed Tomography (CCT) is strongly correlated to functional outcome and quality of life following cardiac surgery * Early mobile health intervention is feasible and cost-effective

Design:

This is a bi-center, prospective, randomized controlled, parallel, two-arm, open-label, blinded evaluation (PROBE) trial with a superiority design. The study population will consist of a representative group (n=120) of older patients scheduled for open heart surgery who fulfill the requirements according to inclusion and exclusion criteria. The patients will be recruited from 2 cardiac surgery centers in northern and central Denmark.

Patients are stratified after center and subsequently randomly allocated (1:1) to receive mobile health intervention as an adjunct to standard care (Intervention Group), or standard care alone (Control group) for 6 weeks after discharge. Follow-up is planned with an outpatient visit 6 weeks after discharge, and a telephone interview 6 months after surgery.

Patients in the intervention group receive a 6-week home-based CR using the ICURA app and sensor-based technology (ICURA ApS, Copenhagen, Denmark). During the hospital stay patients in the intervention group are introduced to the app's usage, and an individualized training plan is collaboratively created and subsequently tailored by a physiotherapist. The patients are equipped with a case including an ICURA -sensor with a charger, an illustrative quick guide, and a contact telephone number. According to the patient's preference, the app is either installed on their own mobile phone or provided on a separate mobile device.

The comprehensive mobile health intervention includes customized training programs, activity tracking, visualization of exercises with videos, text message communication with patients, and a password-protected webpage for physiotherapists to customize training programs and track patient activity.

A few days after discharge, patients in the intervention group will receive the first call from the physiotherapist, to ensure, that the patient is using the ICURA app actively. The patients will receive two calls per week for the first two weeks and as required the following four weeks.

• Change (Δ) in 10-meter Walk Test (10MWT) baseline vs. 6-week FU [Срок оценки: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge]
• Difference in 6-minute Walk Test (6MWT) between groups at 6-week FU [Срок оценки: 6 weeks (+/- 4 days) after discharge]
• Change (Δ) in WHO-5-score baseline vs. 6-week FU [Срок оценки: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery]
• Change (Δ) in ASS-2-score baseline vs. 6-week FU [Срок оценки: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery]
• Change (Δ) in MDI-2-score baseline vs. 6-week FU [Срок оценки: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery]
• Change (Δ) in Self-reported Physical Activity baseline vs. 6-week FU [Срок оценки: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery]
• Change (Δ) in EuroQol-score baseline vs. 6-week FU [Срок оценки: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery]
• Change in skeletal muscle mass baseline vs. 6-week FU [Срок оценки: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge]
• Cost-effectiveness analysis [Срок оценки: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery]
• Changes in markers of musculoskeletal health through blood samples baseline vs. 6-week FU [Срок оценки: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge]
• Changes in markers of inflammation through blood samples baseline vs. 6-week FU [Срок оценки: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge]
• Changes in markers of nutrition through blood samples baseline vs. 6-week FU [Срок оценки: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge]