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NCT Number: NCT04663373

Prognostic Impact of Physical Activity Patterns After Percutaneous Coronary Intervention (PIPAP Study)

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.

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Key information

Conditions

Physical Activity Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Motor Activity Myocardial Ischemia Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Preventive Cardiology, Bern University Hospital

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible for ambulatory cardiac rehabilitation (CR, patients not living in nursing home, not enrolling in stationary CR)
  • Signing informed consent

Exclusion criteria

  • Staged PCI;
  • Previous participation in this study;
  • Inability or contraindications to undergo CR (nursing home residence, stationary CR, orthopedic or neurologic impairment prohibiting physical exercise, psychiatric conditions)
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc..

Treatment and study plan

Step counting

Other

Patients are given a physical activity tracker (wrist band) that they are asked to wear for two weeks after discharge from percutaneous coronary intervention.

Primary outcomes

  1. Major adverse cardiac event

    Time frame: One year

    Major Adverse Cardiac Events (MACE) at one year after percutaneous coronary intervention

Secondary outcomes

  1. Number of steps

    Time frame: One year

    Number of steps per day will be measured during the first two weeks after Hospital discharge. Mean steps per day over the two weeks wearing time will be related to MACE at one year.

  2. Time spent with moderate to high intensity activity per day

    Time frame: One year

    Physical activity will be measured during the first two weeks after Hospital discharge and association with MACE at one year will be tested

  3. Sedentary time

    Time frame: One year

    Sedentary time will be measured during the first two weeks after Hospital discharge and association with MACE at one year will be tested

  4. Changes in number of daily steps

    Time frame: One year

    Changes in number of steps during the two weeks of tracker wearing time will be measured during the first two weeks after Hospital discharge and association with MACE at one year will be tested

  5. Changes in volume of daily physical activity

    Time frame: One year

    Predictors for changes in volume of daily physical activity during the two weeks after Hospital discharge will be sought from anthropometric Parameters, medical history, cardiovascular Risk factors, socioeconomic Parameters, completion of cardiac rehabilitation by multivariate regression analysis

  6. Identification of predictors of number of steps

    Time frame: One month

    Predictors of steps during the two weeks after Hospital discharge will be sought from anthropometric Parameters, medical history, cardiovascular Risk factors, socioeconomic Parameters, completion of cardiac rehabilitation by multivariate regression analysis

  7. Identification of predictors of physical activity

    Time frame: One month

    Predictors of physical activity during the two weeks after Hospital discharge will be sought from anthropometric Parameters, medical history, cardiovascular Risk factors, socioeconomic Parameters, completion of cardiac rehabilitation by multivariate regression analysis

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Prognostic Impact of Physical Activity Patterns After Percutaneous Coronary Intervention - The PIPAP Observational Study

Acronym: PIPAP

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 11, 2020
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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