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

NCT ID: NCT04663373

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 568 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-11-01

Brief 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.

Conditions

Physical Activity; Coronary Artery Disease

Keywords

Step counting; Accelerometer; Percutaneous coronary intervention; Risk prediction; Major adverse cardiac event

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Step counting

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

Intervention Type: OTHER

Eligibility Criteria

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..

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias Wilhelm, MD

Role: STUDY_CHAIR

Preventive Cardiology & Sports Medicine

Eser Prisca, PhD

Role: STUDY_DIRECTOR

Preventive Cardiology & Sports Medicine

Locations

Department of Preventive Cardiology, Bern University Hospital

Bern, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 36247455 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36247452 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ID 2020-01861

Identifier Type: -

Identifier Source: org_study_id