The Physical Activity Post Myocardial Infarction SWEDEHEART Prospective Cohort Study (ACTIVITY)

February 9, 2025 updated by: Maria Bäck, Sahlgrenska University Hospital

The Physical Activity Post Myocardial Infarction SWEDEHEART Prospective Cohort Study (ACTIVITY-SWEDEHEART)

The association between objectively measured physical activity intensities (light, moderate and vigorous), sedentary time and clinical outcomes has not been clarified in patients after a myocardial infarction.

The overall objective of the study is to explore associations between accelerometer measured physical activity and clinical outcomes after a myocardial infarction. Moreover, the association between changes in physical activity and outcomes will be assessed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It is estimated to include 4000 patients with myocardial infarction during 2 years. Patients will wear the accelerometer for 7 days at follow-up visits (2 months and 1 year) after discharge. The investigators will examine the dose-response relations of several exposure variables from the accelerometer measurements with the outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Alingsås, Sweden
        • Recruiting
        • Alingsas lasarett
        • Contact:
          • Petter Tollemark
      • Bollnäs, Sweden
        • Recruiting
        • Bollnäs sjukhus
        • Contact:
          • Maria Östman
      • Bäckefors, Sweden
      • Eksjö, Sweden
        • Recruiting
        • Höglandssjukhuset Eksjö
        • Contact:
          • Helene Warin
      • Enköping, Sweden
        • Recruiting
        • Lasarettet Enköping
        • Contact:
          • Görel Stengård
      • Gothenburg, Sweden
      • Gävle, Sweden
        • Not yet recruiting
        • Gävle Sjukhus
        • Contact:
          • Anna Cutler
      • Helsingborg, Sweden
        • Recruiting
        • Helsingborgs Lasarett
        • Contact:
          • Bjarne Madsen Härdig
      • Jönköping, Sweden
        • Recruiting
        • Jönköping Ryhov Hospital
        • Contact:
      • Kalix, Sweden
        • Recruiting
        • Kalix sjukhus
        • Contact:
          • Magdalena Engren Jonsson
      • Kalmar, Sweden
        • Recruiting
        • Länssjukhuset Kalmar
        • Contact:
          • Charlotta Lans
      • Karlstad, Sweden
        • Recruiting
        • Centralsjukhuset Karlstad
        • Contact:
          • Karin Arinell
      • Katrineholm, Sweden
        • Recruiting
        • Kullbergska sjukhuset
        • Contact:
          • Hanna Hafström Eng
      • Köping, Sweden
        • Recruiting
        • Västmanlands sjukhus Köping
        • Contact:
          • Marianne Ordell Schieman
      • Linköping, Sweden
        • Recruiting
        • Universitetssjukhuset Linköping
        • Contact:
          • Sabina Borg
      • Luleå, Sweden
        • Recruiting
        • Sunderby Sjukhus
        • Contact:
          • Maarit Kylmamaa
      • Lysekil, Sweden
        • Recruiting
        • NU-sjukvården Lysekil
        • Contact:
          • Marica Stenström
      • Malmö, Sweden
        • Recruiting
        • Skåne Universitetssjukhus Malmö
        • Contact:
          • Margret Leosdottir
      • Norrköping, Sweden
        • Withdrawn
        • Vrinnevisjukhuset
      • Oskarshamn, Sweden
        • Recruiting
        • Oskarshamns sjukhus
        • Contact:
          • Sofi Karlsson
      • Sala, Sweden
        • Recruiting
        • Västmanlands sjukhus Sala
        • Contact:
          • Marica Hallsten Larsson
      • Sandviken, Sweden
        • Recruiting
        • Sandvikens sjukhus
        • Contact:
          • Anna Cutler
      • Simrishamn, Sweden
        • Recruiting
        • Capio Närsjukhus Simrishamn
        • Contact:
          • Pernilla Rosberg Håkansson
      • Skövde, Sweden
        • Recruiting
        • Skaraborgs sjukhus Skövde
        • Contact:
          • Frida Brevitz
      • Stockholm, Sweden
        • Recruiting
        • Södersjukhuset
        • Contact:
          • Robin Hofmann
      • Stockholm, Sweden
        • Recruiting
        • Karolinska University Hospital Solna and Huddinge
        • Contact:
      • Stockholm, Sweden
        • Recruiting
        • Capio St Göran
        • Contact:
          • Anneli Johansson
      • Strömstad, Sweden
        • Recruiting
        • NU-sjukvården Strömstad
        • Contact:
          • Barbro Limnell
      • Söderhamn, Sweden
        • Not yet recruiting
        • Söderhamns sjukhus
        • Contact:
          • Anna-Sara Raphael
      • Umeå, Sweden
        • Active, not recruiting
        • Norrlands Universitetssjukhus Umeå
      • Uppsala, Sweden
        • Recruiting
        • Akademiska Sjukhuset
        • Contact:
          • Emil Hagström
      • Varberg, Sweden
        • Recruiting
        • Hallands sjukhus Varberg
        • Contact:
          • Frida Johansson
      • Visby, Sweden
      • Värnamo, Sweden
        • Recruiting
        • Värnamo sjukhus
        • Contact:
          • Monica Cederblad
      • Västervik, Sweden
        • Recruiting
        • Västerviks sjukhus
        • Contact:
          • Emmy Cheruiyot Johansson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with myocardial infarction will be recruited at the first (2 months after discharge) cardiac rehabilitation follow-up visit at hospital.

Description

Inclusion Criteria:

  • Signed informed consent
  • Diagnosis of a type 1 myocardial infarction registered in SWEDEHEART
  • Age 18-79 years at discharge from hospital
  • Attending the first visit in the cardiac rehabilitation (CR) registry SEPHIA (2 months after discharge)

Exclusion Criteria:

  • Inability to understand Swedish
  • Non-ambulatory
  • Any mental condition that may interfere with the possibility for the patient to comply with the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort group
Diagnosis of a type 1 myocardial infarction registered in SWEDEHEART Age 18-79 years at discharge from hospital
Other: Accelerometer measurement
Study personnel will initiate an accelerometer and inform the patient to wear the accelerometer with an elastic belt on their right hip during waking hours for seven consecutive days. Moreover, patients are instructed to register their wear time in an activity diary in paper form. In addition, patients will register their working hours, if relevant. After seven days, patients send back the accelerometer and diary in a pre-paid envelope. The same procedure is repeated at the second follow-up visit at 1 year.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular event (MACE)
Time Frame: 1 year after the index cardiac event
The composite incidence of cardiovascular mortality, non-fatal myocardial infarction, non-fatal ischemic stroke, coronary revascularization, hospitalization for new or worsening heart failure
1 year after the index cardiac event

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiovascular mortality
Time Frame: 1 year after the index cardiac event
Incidence of cardiovascular mortality
1 year after the index cardiac event
Non-fatal myocardial infarction
Time Frame: 1 year after the index cardiac event
Incidence of non-fatal myocardial infarction
1 year after the index cardiac event
Non-fatal ischemic stroke
Time Frame: 1 year after the index cardiac event
Incidence of non-fatal ischemic stroke
1 year after the index cardiac event
Coronary revascularization
Time Frame: 1 year after the index cardiac event
Incidence of coronary revascularization
1 year after the index cardiac event
Heart failure
Time Frame: 1 year after the index cardiac event
Incidence of hospitalization for new or worsening heart failure
1 year after the index cardiac event
Major adverse cardiovascular event (MACE)
Time Frame: 3 years after the index cardiac event
The composite incidence of cardiovascular mortality, non-fatal myocardial infarction, non-fatal ischemic stroke, coronary revascularization, hospitalization for new or worsening heart failure
3 years after the index cardiac event
Cardiovascular mortality
Time Frame: 3 years after the index cardiac event
Incidence of cardiovascular mortality
3 years after the index cardiac event
Non-fatal myocardial infarction
Time Frame: 3 years after the index cardiac event
Incidence of non-fatal myocardial infarction
3 years after the index cardiac event
Non-fatal ischemic stroke
Time Frame: 3 years after the index cardiac event
Incidence of non-fatal ischemic stroke
3 years after the index cardiac event
Coronary revascularization
Time Frame: 3 years after the index cardiac event
Incidence of coronary revascularization
3 years after the index cardiac event
Heart failure
Time Frame: 3 years after the index cardiac event
Incidence of hospitalization for new or worsening heart failure
3 years after the index cardiac event
All-cause death
Time Frame: 1 year after the index cardiac event
Incidence of all-cause death
1 year after the index cardiac event
All-cause death
Time Frame: 3 year after the index cardiac event
Incidence of all-cause death
3 year after the index cardiac event

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Smoking status
Time Frame: 1 year after the index cardiac event
0=Never smoker, 1=Former smoker > 1 month, 2=Smoker
1 year after the index cardiac event
The Swedish Healthy diet questionnaire
Time Frame: 1 year after the index cardiac event
Four questions with Likert scale 0-3 points. Higher scores indicate better outcomes
1 year after the index cardiac event
Health-related quality of life (EuroQol- 5 Dimension)
Time Frame: 1 year after the index cardiac event
EuroQol- 5 Dimension (EQ-5D-3L) The EQ-5D-3L comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Higher scores indicate better outcomes.
1 year after the index cardiac event
Health-related quality of life (EQ visual analogue scale)
Time Frame: 1 year after the index cardiac event
EQ visual analogue scale (EQ VAS). The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
1 year after the index cardiac event
Triglycerides
Time Frame: 1 year after the index cardiac event
Plasma levels of triglycerides (mmol/L). Higher values indicate worse outcome.
1 year after the index cardiac event
High-density lipoprotein (HDL) cholesterol
Time Frame: 1 year after the index cardiac event
Plasma levels of HDL (mmol/L). Higher values indicate better outcome
1 year after the index cardiac event
Low-density lipoprotein (LDL) cholesterol
Time Frame: 1 year after the index cardiac event
Plasma levels of LDL cholesterol (mmol/L). Higher values indicate worse outcome
1 year after the index cardiac event
Hemoglobin A1c (HbA1c)
Time Frame: 1 year after the index cardiac event
HbA1c (mmol/L). Measures the amount of blood sugar. Higher values indicate worse outcome
1 year after the index cardiac event
Blood pressure
Time Frame: 1 year after the index cardiac event
mmHg
1 year after the index cardiac event
Body weight
Time Frame: 1 year after the index cardiac event
kg
1 year after the index cardiac event
Waist circumference
Time Frame: 1 year after the index cardiac event
cm
1 year after the index cardiac event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sahlgrenska University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gothia Forum - Center for Clinical Trial

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria Bäck, PhD, Department of physiotherapy, Sahlgrenska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 26, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 277371

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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