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NCT Number: NCT04268992

Effect of Long-term Exercise on Haemostasis and Inflammation in Patients With Coronary Artery Disease

Introduction: Regular exercise training improves prognosis in patients with coronary artery disease (CAD). This study investigates whether the beneficial effects of exercise can be partly explained by favourable changes in haemostasis and inflammation.

Methods: 150 CAD patients are randomised to a supervised long-term exercise program (3 months) or usual care. Blood samples are obtained at baseline, 1.5 months, and 3 months after randomisation.

Results: The investigators will evaluate platelet turnover and aggregation, coagulation, fibrinolysis, and inflammatory markers before and after short- and long-term exercise, and the two randomised groups will be compared.

Perspectives: The present study will increase our knowledge of the beneficial mechanisms underlying the effect of exercise in CAD patients, potentially paving the way for improved exercise recommendations.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Coronary Disease Exercise Heart Diseases Hemostasis Inflammation Motor Activity Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Hospital of the Faroe Islands

Tórshavn, 100, Faroe Islands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Angiographically verified coronary artery disease with stenosis of at least 50% or previous percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG) surgery.
  • Diagnosis or revascularisation have been made at least 12 months prior to inclusion.

Exclusion criteria

  • Inability to perform strenuous exercise
  • Anticoagulant treatment
  • Heart failure (ejection fraction <30% or NYHA >2)
  • Implanted implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT)
  • Serious arrhythmia requiring hospitalisation within the last 6 months
  • Severe valvular heart disease
  • Chronic obstructive pulmonary disease GOLD IV

Treatment and study plan

Long-term exercise

Other

All patients randomised to long-term exercise will perform exercise training at least three times a week for three months. The exercise is supervised and individualised.

Primary outcomes

  1. Changes in fibrinolytic biomarkers: tissue plasminogen activator (t-PA) and plasminogen activator inhibitor-1 (PAI-1).

    Time frame: 3 months

    Changes in fibrinolytic biomarkers in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare fibrinolytic biomarkers assessed at baseline and after three months of supervised exercise for every patient.

  2. Changes in clot maximum absorbance using the clot lysis assay.

    Time frame: 3 months

    Changes in maximum absorbance in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare clot maximum absorbance assessed at baseline and after three months of supervised exercise for every patient.

  3. Changes in clot lysis time using the clot lysis assay.

    Time frame: 3 months

    Changes in clot lysis time in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare clot lysis time assessed at baseline and after three months of supervised exercise for every patient.

  4. Changes in area under the curve using the clot lysis assay.

    Time frame: 3 months

    Changes in area under the curve in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare area under the curve assessed at baseline and after three months of supervised exercise for every patient.

Secondary outcomes

  1. Changes in platelet aggregation using arachidonic acid (ASPI) as agonist.

    Time frame: 3 months

    Changes in platelet aggregation with ASPI as agonist in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare the results assessed at baseline and after three months of supervised exercise for every patient.

  2. Changes in platelet aggregation using adenosine diphosphate (ADP) as agonist.

    Time frame: 3 months

    Changes in platelet aggregation with ADP as agonist in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare the results assessed at baseline and after three months of supervised exercise for every patient.

  3. Changes in platelet aggregation using thrombin receptor activating peptide-6 (TRAP) as agonist.

    Time frame: 3 months

    Changes in platelet aggregation with TRAP as agonist in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare the results assessed at baseline and after three months of supervised exercise for every patient.

  4. Changes in thrombin generation assessing lag-time until initial thrombin generation.

    Time frame: 3 months

    Changes in lag-time until initial thrombin generation in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare the results assessed at baseline and after three months of supervised exercise for every patient.

  5. Changes in thrombin generation assessing maximum concentration of thrombin.

    Time frame: 3 months

    Changes in maximum concentration of thrombin in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare the results assessed at baseline and after three months of supervised exercise for every patient.

  6. Changes in thrombin generation assessing time to peak.

    Time frame: 3 months

    Changes in time to peak in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare the results assessed at baseline and after three months of supervised exercise for every patient.

  7. Changes in thrombin generation assessing endogenous thrombin potential.

    Time frame: 3 months

    Changes in endogenous thrombin potential in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare the results assessed at baseline and after three months of supervised exercise for every patient.

  8. Changes in coagulation biomarkers: APTT, INR, Factor VIII, vWF.

    Time frame: 3 months

    Changes in coagulation biomarkers in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare coagulation biomarkers assessed at baseline and after three months of supervised exercise for every patient.

  9. Changes in inflammatory biomarkers: CRP, multiple interleukins, tumor necrosis factor alpha (TNF-α), interferon gamma (INF-γ) and more.

    Time frame: 3 months

    Changes in inflammatory biomarkers in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare inflammatory biomarkers assessed at baseline and after three months of supervised exercise for every patient.

Other outcomes

  1. Changes in cardiorespiratory performance: maximal oxygen uptake

    Time frame: 3 months

    Changes in maximal oxygen uptake in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group).

  2. Changes in cardiorespiratory performance: maximal power output

    Time frame: 3 months

    Changes in maximal power output in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group).

  3. Changes in physical health and mental health (quality of life) assessed by the SF-36v2 questionnaire.

    Time frame: 3 months

    Changes in physical and mental health in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group).

  4. Incidence of adverse events associated with the exercise intervention.

    Time frame: 3 months

    Number of adverse events (severe, moderate or mild) and training related injuries in coronary artery disease patients who are randomised to long-term exercise.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • National Hospital of the Faroe Islands

Registry information

Official study title

Effect of Long-term Exercise on Haemostasis and Inflammation Compared With Standard Care in Patients With Stable Coronary Artery Disease: a Randomised Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Feb 13, 2020
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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