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

Coronary Artery Disease Clinical Trial

— PIPAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04663373
• Other study ID #: ID 2020-01861
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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..

Related Conditions & MeSH terms

• Coronary Artery Disease
• Physical Activity

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Switzerland	Department of Preventive Cardiology, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac event	Major Adverse Cardiac Events (MACE) at one year after percutaneous coronary intervention	One year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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