Prognostic Impact of Physical Activity Patterns After Percutaneous Coronary Intervention (PIPAP Study)
Condition: Physical Activity; Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      Physical activity monitoring after coronary bypass grafting and other major surgeries has
      been found to be predictive for hospital readmission and adverse outcome. In patients after
      percutaneous coronary intervention (PCI) it has been found that a patient reported activity
      score is predictive of 3 year major adverse coronary event (MACE). It is not known whether
      physical activity shortly after discharge from PCI is predictive of one-year MACE. Early
      identification of patients at increased risk of MACE would facilitate the intensification of
      preventive strategies in these patients.

      Primary objective is the quantification of physical activity (daily steps) during the first
      two weeks after hospital discharge as a predictor for MACE at one year. Secondary objectives
      are: 1) Comparison between daily steps and objectively measured activity counts (divided in
      time spent in moderate-to-vigorous activity, light activity and sedentary activity), as well
      as patient reported activity; 2) Association of daily steps after one year with reaching
      targets for systolic blood pressure, low-density lipoprotein cholesterol (LDL-C), body mass
      index (BMI) and glycated haemoglobin (HbA1c); 3) Comparison of daily steps after hospital
      discharge and MACE between non cardiac rehabilitation (CR), conventional hospital based CR,
      tele-CR and modular CR participants; 4) Comparison of daily steps at one year after hospital
      discharge in different CR groups.
    

Detailed description: 
      Study design

      This is a monocentric open label explorative study (with primary objective to assess the
      predictive value of daily steps for MACE). Patients will be asked to wear an activity tracker
      for two weeks following hospital discharge. Patients who participate in any form of CR in our
      institution and attend the routine check-up 12 month after PCI in our institution will be
      asked to wear the activity tracker again for two weeks.

      Study intervention

      Patients will be informed about the study by the prevention team (advanced nurse
      practitioners) usually on the day of discharge from PCI during the routine visit by this team
      to inform patients about the different options of CR. Patients will be provided with an
      activity tracker in the form of a wrist band, the patient information sheet including
      informed consent (IC), the International Physical Activity Questionnaires Short-Form
      (IPAQ-SF) and an addressed and prepaid envelope. They are asked to read the patient
      information when arrived at home, sign the IC when willing to participate and wear the wrist
      band continuously for two weeks after hospital discharge. After that, they should send the
      wrist band, the filled in IPAQ-SF and signed IC in the provided envelope to our institute. If
      they are unwilling to participate, they can send the activity tracker back straight away.
      Patients attending the clinical routine check-up after 12 months in our institution will be
      asked to wear the activity tracker again for two weeks.
    

Intervention name(s): Step counting
Intervention type(s): Other
Intervention description(s): Patients are given a physical activity tracker (wrist band) that they are asked to wear for two weeks after discharge from percutaneous coronary intervention.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are treated by percutaneous coronary intervention at the University Clinic of
        Cardiology, University Hospital Bern, Berne, Switzerland. Consecutive patients who are
        eligible for ambulatory CR are seen by the prevention team (nurse practitioners) usually on
        the day of hospital discharge from PCI and will be informed about the different forms of CR
        and the study.
      
Keywords: Step counting; Accelerometer; Percutaneous coronary intervention; Risk prediction; Major adverse cardiac event