Personalized Activity Intervention in Rehabilitation After Cardiac Operations (the PACO Trial)

Coronary Artery Disease Clinical Trial

— PACO  

Official title:

Personalized Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in Rehabilitation After Cardiac Operations (the PACO Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03470246
• Other study ID #: KUH5101117
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2018
• Est. completion date: March 1, 2028

Study information

• Verified date: August 2019
• Source: Kuopio University Hospital
• Contact: Ville Vasankari, B.M. with thesis
• Phone: 505208148
• Email: villevas[@]uef.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: March 1, 2028
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Coronary Artery Disease
• Coronary Disease
• Mitral Valve Insufficiency
• Myocardial Ischemia

Intervention

Behavioral:
• PACO intervention for CABG patients
The PACO intervention is based on post-operative guidance to replace prolonged SB with PA in the rehabilitation of patients recovering from coronary artery bypass grafting (CABG). The guidance will be provided to the patients with the combination of ExSed smart phone application, accelerometer and cloud system. In addition, exercise guidance (short video files) and regular mobile phone contacts from physiotherapist will be provided to the intervention patients.
• PACO intervention for AVR patients
The PACO intervention is based on post-operative guidance to replace prolonged SB with PA in the rehabilitation of patients recovering from aortic valve replacement (AVR). The guidance will be provided to the patients with the combination of ExSed smart phone application, accelerometer and cloud system. In addition, exercise guidance (short video files) and regular mobile phone contacts from physiotherapist will be provided to the intervention patients.
• PACO intervention for MVR patients
The PACO intervention is based on post-operative guidance to replace prolonged SB with PA in the rehabilitation of patients recovering from mitral valve repair (MVR). The guidance will be provided to the patients with the combination of ExSed smart phone application, accelerometer and cloud system. In addition, exercise guidance (short video files) and regular mobile phone contacts from physiotherapist will be provided to the intervention patients.

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (3)

Lead Sponsor	Collaborator
Kuopio University Hospital	Turku University Hospital, UKK Institute

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in mean daily number of steps	The improvement in mean daily number of steps after 3 months from discharge. In addition, the follow-up will be continued until 12 months after discharge. The baseline values of mean daily number of steps will be determined in a 7-day accelerometer measurements conducted to the patients before the elective cardiac operation. The mean daily number of steps after the first 3 and 12 months of post-operative rehabilitation at home will be also determined in 7-day (24 h) accelerometer measurements. The raw accelerometer data will be analyzed with Mean Amplitude Deviation and Angle for Posture Estimation -algorithms to recognize the daily steps for the 7 days of which average will be calculated for each study patient.	Improvement between baseline (during the last preoperative month) and first 3 (and 12) months after discharge.
Secondary	Change in mean daily accumulated total time of light PA and MVPA	The post-operative change in patient's mean daily accumulated total time of light and moderate to vigorous physical activity.	Change between baseline (during the last preoperative month) and first 3 months after discharge.
Secondary	Change in mean daily total time of sedentary behaviour (SB)	The post-operative change in patient's mean daily total time of SB.	Change between baseline (during the last preoperative month) and first 3 months after discharge.
Secondary	Change in maximal oxygen consumption	The evolvement of patient's maximal oxygen consumption (VO2 peak) will be determined in 6 minute walking test, conducted to the patients twice (after 1 and 3 months) post-operatively. Only a part of the randomized patients coming from city areas of Kuopio and Turku will be included to the measurements of maximal oxygen consumption.	Change between the first and third months after discharge.
Secondary	Improvement in self-perceived quality of life (QoL) assessed with SAQ-7 -questionnaire	The improvement in patient's post-operative quality of life after 3 months of rehabilitation. The quality of life will be determined with Seattle Angina Questionnaire 7 (SAQ-7).	Improvement between baseline (during the last preoperative month) and first 3 months after discharge.
Secondary	Improvement in self-perceived quality of life (QoL) assessed with SF-36 -questionnaire	The improvement in patient's post-operative quality of life after 3 months of rehabilitation. The quality of life will be determined with SF-36 -questionnaire.	Change between baseline (during the last preoperative month) and first 3 months after discharge.
Secondary	Improvement in self-perceived quality of life (QoL) assessed with 15 D -questionnaire	The improvement in patient's post-operative quality of life after 3 months of rehabilitation. The quality of life will be determined with 15 D -questionnaire.	Improvement between baseline (during the last preoperative month) and first 3 months after discharge.
Secondary	Improvement in self-perceived quality of life (QoL) assessed with PHQ-2 -questionnaire	The improvement in patient's post-operative quality of life after 3 months of rehabilitation. The quality of life will be determined with PHQ-2 -questionnaire.	Improvement between baseline (during the last preoperative month) and first 3 months after discharge.
Secondary	Improvement in self-perceived quality of life (QoL) assessed with Rose Dyspnea Index	The improvement in patient's post-operative quality of life after 3 months of rehabilitation. The quality of life will be determined with Rose Dyspnea Index.	Improvement between baseline (during the last preoperative month) and first 3 months after discharge.
Secondary	Incidence of major cardiovascular events	The major cardiovascular events include: all-cause mortality, any rehospitalizations due to CVD, repeat coronary revascularization, non-operational myocardial infarction and stroke. The incidence of major cardiovascular events will be monitored from the patient records of the hospitals and HILMO database during the first 12 post-operative months. In addition, patients will be asked about cardiovascular events during research telephone contact (after 12 months of rehabilitation).	The first 12 post-operative months
Secondary	Change in the accelerometer-derived portion of deep sleep	The change in patient's deep sleep portion after cardiac operations. Deep sleep will be recognized with accelerometer attached to patient's wrist during sleep. Accelerometer will be used during 7 days.	Change between baseline (during the last preoperative month) and first 3 months after discharge.
Secondary	Change in heart rate variability	The change in the heart rate variability.	Change between baseline (during the last preoperative month) and first 3 months after discharge.