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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04663373
Acronym
PIPAP
Enrollment
568
Registered
2020-12-11
Start date
2020-12-01
Completion date
2023-11-01
Last updated
2023-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Physical Activity

Keywords

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

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.

Interventions

OTHERStep 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.

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

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..

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiac eventOne yearMajor Adverse Cardiac Events (MACE) at one year after percutaneous coronary intervention

Secondary

MeasureTime frameDescription
Time spent with moderate to high intensity activity per dayOne yearPhysical activity will be measured during the first two weeks after Hospital discharge and association with MACE at one year will be tested
Sedentary timeOne yearSedentary time will be measured during the first two weeks after Hospital discharge and association with MACE at one year will be tested
Changes in number of daily stepsOne yearChanges 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
Number of stepsOne yearNumber 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.
Identification of predictors of number of stepsOne monthPredictors 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
Identification of predictors of physical activityOne monthPredictors 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
Changes in volume of daily physical activityOne yearPredictors 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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026