Clinical trial NCT04663373: Prognostic Impact of Physical Activity Patterns After Percutaneous Coronary Intervention (PIPAP Study)
Official title: Prognostic Impact of Physical Activity Patterns After Percutaneous Coronary Intervention - The PIPAP Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Coronary Artery Disease
Keywords: Step counting
Accelerometer
Percutaneous coronary intervention
Risk prediction
Major adverse cardiac event
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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..

Primary outcomes:
measure: Major adverse cardiac event
timeFrame: One year
Secondary outcomes:
measure: Number of steps
timeFrame: One year
measure: Time spent with moderate to high intensity activity per day
timeFrame: One year
measure: Sedentary time
timeFrame: One year
measure: Changes in number of daily steps
timeFrame: One year
measure: Changes in volume of daily physical activity
timeFrame: One year
measure: Identification of predictors of number of steps
timeFrame: One month
measure: Identification of predictors of physical activity
timeFrame: One month
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Preventive Cardiology, Bern University Hospital
Study officials:
affiliation: Preventive Cardiology & Sports Medicine
name: Matthias Wilhelm, MD
role: STUDY_CHAIR
affiliation: Preventive Cardiology & Sports Medicine
name: Eser Prisca, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.