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  • 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)

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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)
  1. Ville Vasankari1,2,
  2. Jari Halonen1,2,
  3. Pauliina Husu3,
  4. Henri Vähä-Ypyä3,
  5. Kari Tokola3,
  6. Jaana Suni3,
  7. Harri Sievänen3,
  8. Vesa Anttila4,
  9. Juhani Airaksinen4,
  10. Tommi Vasankari3,
  11. Juha Hartikainen1,2
  1. 1Heart Center, Kuopio University Hospital, Kuopio, Finland
  2. 2Department of Medicine, University of Eastern Finland, Kuopio, Finland
  3. 3UKK Institute for Health Promotion Research, Tampere, Finland
  4. 4Heart Center, Turku University Hospital, Turku, Finland
  1. Correspondence to Ville Vasankari; villevas{at}uef.fi

Abstract

Introduction Personalized intervention to increase physical Activity and reduce sedentary behaviour in rehabilitation after Cardiac Operations (PACO) is a smartphone-based and accelerometer-based eHealth intervention to increase physical activity (PA) and reduce sedentary behaviour (SB) among patients recovering from cardiac surgery.

Design Prospective randomised controlled trial.

Methods and analysis The present protocol describes a randomised controlled clinical trial to be conducted in the Heart Centres of Kuopio and Turku university hospitals. The trial comprises 540 patients scheduled for elective coronary artery bypass grafting, aortic valve replacement or mitral valve repair. The patients will be randomised into two groups. The control group will receive standard postsurgical rehabilitation guidance. The eHealth intervention group will be given the same guidance together with personalised PA guidance during 90 days after discharge. These patients will receive personalised daily goals to increase PA and reduce SB via the ExSedapplication. Triaxial accelerometers will be exploited to record patients’ daily accumulated PA and SB, and transmit them to the application. Using the accelerometer data, the application will provide online guidance to the patients and feedback of accomplishing their activity goals. The data will also be transmitted to the cloud, where a physiotherapist can monitor individual activity profiles and customise the subsequent PA and SB goals online. The postoperative improvement in patients’ step count, PA, exercise capacity, quality of sleep, laboratory markers, transthoracic echocardiography (TTE) parameters and quality of life, and reduction in SB and incidence of major cardiac events are investigated as outcomes.

Conclusions The PACO intervention aims to build a personalised eHealth tool for the online tutoring of cardiac surgery patients.

Trial registration number NCT03470246.

  • aortic valve replacement
  • aortic valve stenosis
  • coronary artery bypass grafting
  • coronary artery disease
  • ehealth
  • exercise
  • mitral valve regurgitation
  • mitral valve repair
  • rehabilitation

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjsem-2019-000539

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    Footnotes

    • Contributors VV, JH, PH, HV-Y, KT, JS, HS, VA, JA, TV and JHar contributed to the conception or design of the work. VV, JH, KT, TV and JHar contributed to the acquisition, analysis or interpretation of the data for the work. VV drafted the manuscript. All authors critically revised the manuscript and gave final approval and agreed to be accountable for all aspects of the work ensuring integrity and accuracy.

    • Funding This work was supported by Yrjö Jahnsson Foundation (grant number 6992), Research Foundation of North Savo Hospital District (VTR), and Ministry of Education and Culture of Finland.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval The Ethics committee of North Savo Hospital district (ID: 304/2017).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement There are no data in this work. All data relevant to the study are included in the article or uploaded as supplementary information.