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Physical ActivityPIPAPNCT04663373

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

An observational study of Physical Activity and Coronary Artery Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Physical Activity, Coronary Artery Disease
What is being tested?
Step counting
How many people
568 participants
Where
1 siteSwitzerland
Study dates
1 Dec 2020to 1 Nov 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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..

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Department of Preventive Cardiology, Bern University Hospital

    Bern, 3010

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
Step counting
Keywords
Step counting, Accelerometer, Percutaneous coronary intervention, Risk prediction, Major adverse cardiac event
Medical subject headings
Motor Activity, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Step countingOther

    Patients are given a physical activity tracker (wrist band) that they are asked to wear for two weeks after discharge from percutaneous coronary intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major adverse cardiac event

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

    Measured: One year

Secondary outcomes (7)

  1. 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.

    Measured: One year

  2. 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

    Measured: One year

  3. 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

    Measured: One year

  4. 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

    Measured: One year

  5. 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

    Measured: One year

  6. 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

    Measured: One month

  7. 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

    Measured: One month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2020
  2. Study start1 Dec 2020
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
568 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04663373
Sponsor's protocol ID
ID 2020-01861
Acronym
PIPAP
Status last verified
Nov 2023
First submitted
19 Nov 2020
Last updated
30 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual patient data sharing plan is not yet Ready, patient daily step Counts will be made available to other Researchers together with main clinical patient data.

Publications

  • 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.

    PubMed 36247455

  • 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.

    PubMed 36247452

Questions about this trial

What is this clinical trial studying?

An observational study of Physical Activity and Coronary Artery Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiac event (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04663373, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.

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