Brief Title
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)
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.
Study Type
Interventional
Primary Outcome
Improvement in mean daily number of steps
Secondary Outcome
Change in mean daily accumulated total time of light PA and MVPA
Condition
Coronary Artery Disease
Intervention
PACO intervention for CABG patients
Study Arms / Comparison Groups
CABG control group
Description: The group of coronary artery disease patients receiving the standard postoperative rehabilitation of Kuopio and Turku university hospitals after coronary artery bypass grafting. The post-operative rehabilitation includes written and oral physical activity guidance from a physiotherapist.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
540
Start Date
April 6, 2018
Completion Date
March 1, 2028
Primary Completion Date
January 2022
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).
Gender
All
Ages
30 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Jari Halonen, M.D.; Ph.D., 505208148, [email protected]
Location Countries
Finland
Location Countries
Finland
Administrative Informations
NCT ID
NCT03470246
Organization ID
KUH5101117
Responsible Party
Sponsor
Study Sponsor
Kuopio University Hospital
Collaborators
UKK Institute
Study Sponsor
Jari Halonen, M.D.; Ph.D., Principal Investigator, Heart Center, Kuopio University Hospital
Verification Date
August 2019