NCT04663373: PIPAP

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

Completed Last updated 30 November 2023

What this trial tests

trial testing Step counting in Physical Activity in 568 participants. Completed in 1 November 2023.

Timeline

1 December 2020

Primary endpoint
1 November 2023

1 November 2023

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Status	Completed
Study type	OBSERVATIONAL
Enrollment	568
Start date	1 December 2020
Primary completion	1 November 2023
Estimated completion	1 November 2023
Sites	1 location across Switzerland

Drugs / interventions tested

• Step counting

Conditions studied

• Physical Activity — all drugs for Physical Activity →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

Adults 18 to 79, any sex, with Physical Activity or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Eser P, Gonzalez-Jaramillo N, Weber S, Fritsche J, et al · · 2022 · cited 5× · PMID 36247452 · DOI 10.3389/fcvm.2022.951042
2. Prognostic impact of physical activity patterns after percutaneous coronary intervention. Protocol for a prospective longitudinal cohort. The PIPAP study.
   Gonzalez-Jaramillo N, Eser P, Casanova F, Bano A, et al · · 2022 · PMID 36247455 · DOI 10.3389/fcvm.2022.976539