Coronary Artery DiseasePACONCT03470246
Personalized Activity Intervention in Rehabilitation After Cardiac Operations (the PACO Trial)
A study testing PACO intervention for CABG patients, PACO intervention for AVR patients and PACO intervention for MVR patients in people with Coronary Artery Disease and Aortic Valve Stenosis, run by Kuopio University Hospital at 1 site in Finland.
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… Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Aortic Valve Stenosis, Mitral Valve Insufficiency
- What is being tested?
- PACO intervention for CABG patients, PACO intervention for AVR patients and PACO intervention for MVR patients
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteFinland
- Study dates
- 6 Apr 2018to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- He / she ends up in prolonged intensive care after cardiac operation.
- He / she has a memory disorder (i.e. Alzheimer's disease).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio, 70029
Jari Halonen, M.D., Ph.D., 405885829 ext. +358, jari.halonen@kuh.fi
About this study
Official title: 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.
- Being tested
- PACO intervention for CABG patients, PACO intervention for AVR patients, PACO intervention for MVR patients
- 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
- Medical subject headings
- Coronary Artery Disease, Aortic Valve Stenosis, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACO intervention for CABG patientsBehavioural
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 patientsBehavioural
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 patientsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CABG control group | No intervention | 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. |
| PACO intervention for CABG patients | Experimental | 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. Receives: Behavioral: PACO intervention for CABG patients |
| AVR control group | No intervention | 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. |
| PACO intervention for AVR patients | Experimental | 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. Receives: Behavioral: PACO intervention for AVR patients |
| MVR control group | No intervention | 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. |
| PACO intervention for MVR patients | Experimental | 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. Receives: Behavioral: PACO intervention for MVR patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Improvement between baseline (during the last preoperative month) and first 3 (and 12) months after discharge.
Secondary outcomes (11)
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.
Measured: Change between baseline (during the last preoperative month) and first 3 months after discharge.
Change in mean daily total time of sedentary behaviour (SB)
The post-operative change in patient's mean daily total time of SB.
Measured: Change between baseline (during the last preoperative month) and first 3 months after discharge.
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.
Measured: Change between the first and third months after discharge.
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Improvement between baseline (during the last preoperative month) and first 3 months after discharge.
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).
Measured: The first 12 post-operative months
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.
Measured: Change between baseline (during the last preoperative month) and first 3 months after discharge.
Change in heart rate variability
The change in the heart rate variability.
Measured: Change between baseline (during the last preoperative month) and first 3 months after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start6 Apr 2018
- Primary completionJan 2022 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- UKK Institute, Turku University Hospital
- Responsible party
- Sponsor
- Investigators
- Jari Halonen, M.D.; Ph.D., Principal investigator, Heart Center, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470246
- Sponsor's protocol ID
- KUH5101117
- Acronym
- PACO
- Status last verified
- Aug 2019
- First submitted
- 28 Feb 2018
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35842711Abraham 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.
PubMed 33962483Vasankari 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.
PubMed 31354960
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in Rehabilitation After Cardiac Operations (the PACO Trial)
- ClinicalTrials.gov ID
- NCT03470246
- Acronym / sponsor ID
- PACO / KUH5101117
- Keywords
- Accelerometer, Aortic valve replacement, Aortic valve stenosis, Coronary artery bypass grafting, Coronary artery disease, eHealth, Interactive guidance, Mitral valve insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- UKK Institute, Turku University Hospital
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| CABG control group | No intervention | –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. |
| PACO intervention for CABG patients | Experimental | Behavioral: PACO intervention for CABG patientsThe 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. |
| AVR control group | No intervention | –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. |
| PACO intervention for AVR patients | Experimental | Behavioral: PACO intervention for AVR patientsThe 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. |
| MVR control group | No intervention | –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. |
| PACO intervention for MVR patients | Experimental | Behavioral: PACO intervention for MVR patientsThe 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. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- He / she ends up in prolonged intensive care after cardiac operation.
- He / she has a memory disorder (i.e. Alzheimer's disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACO intervention for CABG patientsThe 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. | Behavioural | PACO intervention for CABG patients |
| PACO intervention for AVR patientsThe 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. | Behavioural | PACO intervention for AVR patients |
| PACO intervention for MVR patientsThe 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. | Behavioural | PACO intervention for MVR patients |
Primary outcome
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.
11 secondary outcomes
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.
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.
Change in maximal oxygen consumption
Time frame: 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.
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.
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.
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.
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.
Incidence of major cardiovascular events
Time frame: 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.
Change in heart rate variability
Time frame: Change between baseline (during the last preoperative month) and first 3 months after discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Derived from this study: PubMed 35842711Vasankari 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.
- Derived from this study: PubMed 33962483Abraham 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.
- Derived from this study: PubMed 31354960Vasankari 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jari Halonen, M.D.; Ph.D. principal investigator
Heart Center, Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACO intervention for CABG patients, PACO intervention for AVR patients and PACO intervention for MVR patients in people with Coronary Artery Disease and Aortic Valve Stenosis, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ville Vasankari, B.M. with thesis (505208148 ext. +358, villevas@uef.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470246, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.