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

August 14, 2019 updated by: Kuopio University Hospital

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
540

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ville Vasankari, B.M. with thesis
  • Phone Number: +358 505208148
  • Email: villevas@uef.fi

Study Contact Backup

Study Locations

  • Finland
      • Kuopio, Finland, 70029
        • Recruiting
        • Kuopio University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: CABG control group
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.
EXPERIMENTAL: PACO intervention for CABG patients
The group of coronary artery disease patients receiving the PACO intervention for CABG patients besides the standard postoperative rehabilitation of Kuopio and Turku university hospitals after coronary artery bypass grafting. The PACO intervention includes activity guidance (i.e. goals to improve daily steps and physical activity levels, and reduce prolonged sitting) provided to the patients with the novel combination of ExSed application, MoveSense accelerometer and cloud system. In addition, exercise guidance (short video files) and regular mobile phone contacts from physiotherapist will be included to the 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.
NO_INTERVENTION: AVR control group
The group of aortic valve stenosis patients receiving the standard postoperative rehabilitation of Kuopio and Turku university hospitals after aortic valve replacement. The post-operative rehabilitation includes written and oral physical activity guidance from a physiotherapist.
EXPERIMENTAL: PACO intervention for AVR patients
The group of aortic valve stenosis patients receiving the PACO intervention for AVR patients besides the standard postoperative rehabilitation of Kuopio and Turku university hospitals after aortic valve replacement. The PACO intervention includes activity guidance (i.e. goals to improve daily steps and physical activity levels, and reduce prolonged sitting) provided to the patients with the novel combination of ExSed application, MoveSense accelerometer and cloud system. In addition, exercise guidance (short video files) and regular mobile phone contacts from physiotherapist will be included to the intervention.
Behavioral: 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.
NO_INTERVENTION: MVR control group
The group of mitral valve insufficiency patients receiving the standard postoperative rehabilitation of Kuopio and Turku university hospitals after mitral valve repair. The post-operative rehabilitation includes written and oral physical activity guidance from a physiotherapist.
EXPERIMENTAL: PACO intervention for MVR patients
The group of mitral valve insufficiency patients receiving the PACO intervention for MVR patients besides the standard postoperative rehabilitation of Kuopio and Turku university hospitals after mitral valve repair. The PACO intervention includes activity guidance (i.e. goals to improve daily steps and physical activity levels, and reduce prolonged sitting) provided to the patients with the novel combination of ExSed application, MoveSense accelerometer and cloud system. In addition, exercise guidance (short video files) and regular mobile phone contacts from physiotherapist will be included to the intervention.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement in mean daily number of steps
Time Frame: Improvement between baseline (during the last preoperative month) and first 3 (and 12) months after discharge.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in mean daily accumulated total time of light PA and MVPA
Time Frame: Change between baseline (during the last preoperative month) and first 3 months after discharge.
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.
Change in mean daily total time of sedentary behaviour (SB)
Time Frame: Change between baseline (during the last preoperative month) and first 3 months after discharge.
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.
Change in maximal oxygen consumption
Time Frame: Change between the first and third months after discharge.
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.
Improvement in self-perceived quality of life (QoL) assessed with SAQ-7 -questionnaire
Time Frame: Improvement between baseline (during the last preoperative month) and first 3 months after discharge.
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.
Improvement in self-perceived quality of life (QoL) assessed with SF-36 -questionnaire
Time Frame: Change between baseline (during the last preoperative month) and first 3 months after discharge.
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.
Improvement in self-perceived quality of life (QoL) assessed with 15 D -questionnaire
Time Frame: Improvement between baseline (during the last preoperative month) and first 3 months after discharge.
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.
Improvement in self-perceived quality of life (QoL) assessed with PHQ-2 -questionnaire
Time Frame: Improvement between baseline (during the last preoperative month) and first 3 months after discharge.
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.
Improvement in self-perceived quality of life (QoL) assessed with Rose Dyspnea Index
Time Frame: Improvement between baseline (during the last preoperative month) and first 3 months after discharge.
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.
Incidence of major cardiovascular events
Time Frame: The first 12 post-operative months
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
Change in the accelerometer-derived portion of deep sleep
Time Frame: Change between baseline (during the last preoperative month) and first 3 months after discharge.
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.
Change in heart rate variability
Time Frame: Change between baseline (during the last preoperative month) and first 3 months after discharge.
The change in the heart rate variability.
Change between baseline (during the last preoperative month) and first 3 months after discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kuopio University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Turku University Hospital
UKK Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jari Halonen, M.D.; Ph.D., Heart Center, Kuopio University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KUH5101117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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