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

Overview

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: We 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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2020

Interventions

  • Other: Long-term exercise
    • 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.

Arms, Groups and Cohorts

  • Experimental: Long-term exercise
    • Supervised exercise training three times a week for three months.
  • No Intervention: Usual care
    • Patients are not offered supervised exercise.

Clinical Trial Outcome Measures

Primary Measures

  • Long-term effects of exercise on fibrinolysis.
    • Time Frame: 3 months
    • Fibrinolytic biomarkers are analysed at baseline (before randomisation), 1.5 months after long-term exercise/usual care and 3 months after long-term exercise/usual care.

Secondary Measures

  • Long-term effects of exercise on platelets.
    • Time Frame: 3 months
    • Platelet aggregation is analysed by Multiplate Analyzer at baseline (before randomisation), 1.5 months after long-term exercise/usual care and 3 months after long-term exercise/usual care.
  • Long-term effects of exercise on coagulation.
    • Time Frame: 3 months
    • Coagulation biomarkers are measured at baseline (before randomisation), 1.5 months after long-term exercise/usual care and 3 months after long-term exercise/usual care.
  • Long-term effects of exercise on the inflammatory response.
    • Time Frame: 3 months
    • Inflammatory markers are analysed at baseline (before randomisation), 1.5 months after long-term exercise/usual care and 3 months after long-term exercise/usual care.

Participating in This Clinical Trial

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 ICD or CRT
  • Serious arrhythmia requiring hospitalisation within the last 6 months
  • Severe valvular heart disease
  • Chronic obstructive pulmonary disease GOLD IV

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aarhus University Hospital
  • Collaborator
    • National Hospital of the Faroe Islands
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jacobina Kristiansen, M.D., PhD-student – Aarhus University Hospital
  • Overall Contact(s)
    • Jacobina Kristiansen, MD, +298 256085, jacobina30@hotmail.com

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