Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Personalized Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in Rehabilitation After Cardiac Operations (the PACO Trial)
Brief Summary: The PACO trial is a randomized clinical trial conducted in Heart Centers of Kuopio and Turku university hospitals. The coronary artery disease, aortic valve stenosis and mitral valve insufficiency patients preparing for elective coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or mitral valve repair (MVR) will be randomized to either intervention or control group. The specific operation groups (CABG, AVR and MVR) will be analyzed separately. The 7-day baseline measurements of sedentary behaviour (SB), physical activity (PA) and sleep will be conducted to the patients by using the RM42 accelerometer during the pre-operative month.

After the cardiac procedure is completed and the patient is moved to post-operative ward, the control group patients will begin the standard post-operative rehabilitation program of the participating hospitals (activity guidance given by a physiotherapist). Patients in the intervention groups will follow the identical program but after discharge they will also receive personalized activity guidance through the combination of ExSed smart phone application, Suunto MoveSense accelerometer and cloud system during the first 90 days of post-operative rehabilitation. Weekly evolving daily goals to replace SB with PA (daily goals for steps, moderate PA, light PA and standing, and sitting time limit) will be designed for each patient of the intervention groups. A new daily step goal will be delivered from the cloud system to the patient's smart phone in the beginning of each week of the intervention. The daily step goal of the first intervention week is based on patient's walking distance assessed by a physiotherapist in post-operative ward. The following goals will be automatically evolved in the basis of patient's personal average step count of the previous week. The MoveSense accelerometer will measure accumulated levels of SB, PA and sleep, and transmit the data to user's ExSed application with Bluetooth. With information about accumulated levels of SB and PA, the application is able to guide the patient to accomplish the predefined activity goal. The guidance and motivation will be offered with pop-up notifications and histograms (columns are fulfilled according to patient's accumulated daily activity). The researches retain a remote access to the activity data of patients in the cloud system. The ExSed application will be connected to the cloud system with internet connection.

In addition, the patients of the intervention groups will receive short video files (lasting from 1 to 3 minutes) containing exercise guidance from a physiotherapist specialized to cardiac operation patients. These videos are available on the ExSed application during the intervention. The physiotherapist will also contact each patient (by mobile phone) with structured contact form from 1 to 4 times in a month to make sure that the intervention is proceeding as designed.


Options:
A: Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Other: Integrated rehabilitation | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Integrated rehabilitation; Assigned to Arm(s): Intervention group
B: Arm Label: CABG control group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: PACO intervention for CABG patients; Type: EXPERIMENTAL; Interventions: Behavioral: PACO intervention for CABG patients | Arm Label: AVR control group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: PACO intervention for AVR patients; Type: EXPERIMENTAL; Interventions: Behavioral: PACO intervention for AVR patients | Arm Label: MVR control group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: PACO intervention for MVR patients; Type: EXPERIMENTAL; Interventions: Behavioral: PACO intervention for MVR patients | Intervention Type: BEHAVIORAL; Name: PACO intervention for CABG patients; Assigned to Arm(s): PACO intervention for CABG patients | Intervention Type: BEHAVIORAL; Name: PACO intervention for AVR patients; Assigned to Arm(s): PACO intervention for AVR patients | Intervention Type: BEHAVIORAL; Name: PACO intervention for MVR patients; Assigned to Arm(s): PACO intervention for MVR patients
C: Arm Label: Exercise; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Exercise | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Exercise; Assigned to Arm(s): Exercise
D: Arm Label: Medtronic Transcatheter Aortic Valve Replacement Systems; Type: EXPERIMENTAL; Interventions: Device: Medtronic Transcatheter Aortic Valve Replacement Systems | Arm Label: Surgical Aortic Valve Replacement (SAVR); Type: ACTIVE_COMPARATOR; Interventions: Device: Surgical Aortic Valve Replacement (SAVR) | Intervention Type: DEVICE; Name: Medtronic Transcatheter Aortic Valve Replacement Systems; Assigned to Arm(s): Medtronic Transcatheter Aortic Valve Replacement Systems | Intervention Type: DEVICE; Name: Surgical Aortic Valve Replacement (SAVR); Assigned to Arm(s): Surgical Aortic Valve Replacement (SAVR)

Answer: B