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

NCT04663373 | Completed

• 1 other identifier: ID 2020-01861
• Study Type: observational
• Target: 568
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity; Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac event

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

  One year

Secondary Outcomes (7)

• Number of steps

  One year

• Time spent with moderate to high intensity activity per day

  One year

• Sedentary time

  One year

• Changes in number of daily steps

  One year

• Changes in volume of daily physical activity

  One year

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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..

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Preventive Cardiology, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 36247455 DERIVED

• 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.

  PMID: 36247452 DERIVED

MeSH Terms

Conditions

Motor Activity; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Behavior; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Matthias Wilhelm, MD

  Preventive Cardiology & Sports Medicine

  STUDY CHAIR

• Eser Prisca, PhD

  Preventive Cardiology & Sports Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 11, 2020
• Study Start: December 1, 2020
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: not yet decided
• Access Criteria: not yet decided

Locations

CH (1)