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

NCT03470246 | Recruiting

• 1 other identifier: KUH5101117
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in mean daily accumulated total time of light PA and MVPA

  Change between baseline (during the last preoperative month) and first 3 months after discharge.

• Change in mean daily total time of sedentary behaviour (SB)

  Change between baseline (during the last preoperative month) and first 3 months after discharge.

• Change in 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

  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

  Change between baseline (during the last preoperative month) and first 3 months after discharge.

Study Arms (6)

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.

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.

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.

Behavioral: PACO intervention for MVR patients

Interventions

PACO intervention for CABG patients BEHAVIORAL

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 CABG patients

PACO intervention for AVR patients BEHAVIORAL

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 AVR patients

PACO intervention for MVR patients BEHAVIORAL

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.

PACO intervention for MVR patients

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kuopio University Hospital: lead
• UKK Institute: collaborator
• Turku University Hospital: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, 70029, Finland

RECRUITING

Related Publications (3)

• 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.

  PMID: 35842711 DERIVED

• 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.

  PMID: 33962483 DERIVED

• 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.

  PMID: 31354960 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Stenosis; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Officials

• Jari Halonen, M.D.; Ph.D.

  Heart Center, Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ville Vasankari, B.M. with thesis

CONTACT

505208148; villevas@uef.fi

Jari Halonen, M.D.; Ph.D.

CONTACT

405885829; jari.halonen@kuh.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 19, 2018
• Study Start: April 6, 2018
• Primary Completion: January 1, 2022
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)