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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Physical Activity
• Intervention / Treatment: Other: Step counting

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.

• Study Type: Observational
• Enrollment (Actual): 568

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department of Preventive Cardiology, Bern University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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..

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac event	Major Adverse Cardiac Events (MACE) at one year after percutaneous coronary intervention	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of steps	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.	One year
Time spent with moderate to high intensity activity per day	Physical activity will be measured during the first two weeks after Hospital discharge and association with MACE at one year will be tested	One year
Sedentary time	Sedentary time will be measured during the first two weeks after Hospital discharge and association with MACE at one year will be tested	One year
Changes in number of daily steps	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	One year
Changes in volume of daily physical activity	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	One year
Identification of predictors of number of steps	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	One month
Identification of predictors of physical activity	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	One month

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Study Chair: Matthias Wilhelm, MD, Preventive Cardiology & Sports Medicine; Study Director: Eser Prisca, PhD, Preventive Cardiology & Sports Medicine

Publications and helpful links

General Publications

• Gonzalez-Jaramillo N, Eser P, Casanova F, Bano A, Franco OH, Windecker S, Raber L, Wilhelm M. Prognostic impact of physical activity patterns after percutaneous coronary intervention. Protocol for a prospective longitudinal cohort. The PIPAP study. Front Cardiovasc Med. 2022 Sep 30;9:976539. doi: 10.3389/fcvm.2022.976539. eCollection 2022. Erratum In: Front Cardiovasc Med. 2023 Mar 21;10:1176600.
• Eser P, Gonzalez-Jaramillo N, Weber S, Fritsche J, Femiano R, Werner C, Casanova F, Bano A, Franco OH, Wilhelm M. Objectively measured adherence to physical activity among patients with coronary artery disease: Comparison of the 2010 and 2020 World Health Organization guidelines and daily steps. Front Cardiovasc Med. 2022 Sep 28;9:951042. doi: 10.3389/fcvm.2022.951042. eCollection 2022. Erratum In: Front Cardiovasc Med. 2023 Mar 08;10:1173511.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Major adverse cardiac event; Accelerometer; Risk prediction; Step counting
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: ID 2020-01861

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual patient data sharing plan is not yet Ready, patient daily step Counts will be made available to other Researchers together with main clinical patient data.
• IPD Sharing Time Frame: not yet decided
• IPD Sharing Access Criteria: not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No