Clinical trial NCT03470246: Personalized Activity Intervention in Rehabilitation After Cardiac Operations (the PACO Trial)
Official title: Personalized Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in Rehabilitation After Cardiac Operations (the PACO Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Aortic Valve Stenosis
Mitral Valve Insufficiency
Keywords: Accelerometer
Aortic valve replacement
Aortic valve stenosis
Coronary artery bypass grafting
Coronary artery disease
eHealth
Interactive guidance
Mitral valve insufficiency
Mitral valve repair
Rehabilitation
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: UKK Institute
name: Turku University Hospital
First posted: 2018-03-19
Enrollment: 540
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The PACO trial is based on randomized clinical trial. Besides the standard post-operative care, the cardiac operation patients of the intervention groups will receive activity guidance during a 90-day intervention after elective coronary artery bypass grafting, aortic valve replacement or mitral valve repair. In addition, exercise guidance (short video files) and regular mobile phone contacts from physiotherapist will be provided to the intervention patients.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* An eligible patient with coronary artery disease, aortic valve stenosis or mitral valve insufficiency scheduled for elective coronary artery bypass grafting, aortic valve replacement or mitral valve repair operation.
* He / she does not have any severe disease or functional limitation limiting PA (other than CVD).
* He / she is willing to wear a hip- and wrist-worn accelerometer.
* He / she is willing and capable to use a smart phone application.

Exclusion Criteria:

* He / she ends up in prolonged intensive care after cardiac operation.
* He / she has a memory disorder (i.e. Alzheimer's disease).

Primary outcomes:
measure: Improvement in mean daily number of steps
timeFrame: Improvement between baseline (during the last preoperative month) and first 3 (and 12) months after discharge.
Secondary outcomes:
measure: Change in mean daily accumulated total time of light PA and MVPA
timeFrame: Change between baseline (during the last preoperative month) and first 3 months after discharge.
measure: Change in mean daily total time of sedentary behaviour (SB)
timeFrame: Change between baseline (during the last preoperative month) and first 3 months after discharge.
measure: Change in maximal oxygen consumption
timeFrame: Change between the first and third months after discharge.
measure: Improvement in self-perceived quality of life (QoL) assessed with SAQ-7 -questionnaire
timeFrame: Improvement between baseline (during the last preoperative month) and first 3 months after discharge.
measure: Improvement in self-perceived quality of life (QoL) assessed with SF-36 -questionnaire
timeFrame: Change between baseline (during the last preoperative month) and first 3 months after discharge.
measure: Improvement in self-perceived quality of life (QoL) assessed with 15 D -questionnaire
timeFrame: Improvement between baseline (during the last preoperative month) and first 3 months after discharge.
measure: Improvement in self-perceived quality of life (QoL) assessed with PHQ-2 -questionnaire
timeFrame: Improvement between baseline (during the last preoperative month) and first 3 months after discharge.
measure: Improvement in self-perceived quality of life (QoL) assessed with Rose Dyspnea Index
timeFrame: Improvement between baseline (during the last preoperative month) and first 3 months after discharge.
measure: Incidence of major cardiovascular events
timeFrame: The first 12 post-operative months
measure: Change in the accelerometer-derived portion of deep sleep
timeFrame: Change between baseline (during the last preoperative month) and first 3 months after discharge.
measure: Change in heart rate variability
timeFrame: Change between baseline (during the last preoperative month) and first 3 months after discharge.
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Heart Center, Kuopio University Hospital
name: Jari Halonen, M.D.; Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vasankari S, Hartikainen J, Vasankari V, Anttila V, Tokola K, Vaha-Ypya H, Husu P, Sievanen H, Vasankari T, Halonen J. Objectively measured preoperative physical activity and sedentary behaviour among Finnish patients scheduled for elective cardiac procedures: baseline results from randomized controlled trial. BMC Sports Sci Med Rehabil. 2022 Jul 16;14(1):130. doi: 10.1186/s13102-022-00522-1.
citation: Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
citation: Vasankari V, Halonen J, Husu P, Vaha-Ypya H, Tokola K, Suni J, Sievanen H, Anttila V, Airaksinen J, Vasankari T, Hartikainen J. Personalised eHealth intervention to increase physical activity and reduce sedentary behaviour in rehabilitation after cardiac operations: study protocol for the PACO randomised controlled trial (NCT03470246). BMJ Open Sport Exerc Med. 2019 Jul 5;5(1):e000539. doi: 10.1136/bmjsem-2019-000539. eCollection 2019.