Clinical trial NCT04268992: Effect of Long-term Exercise on Haemostasis and Inflammation in Patients With Coronary Artery Disease
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Exercise
Inflammation
Hemostasis
Keywords: Cardiovascular Diseases
Exercise
Hemostasis
Inflammation
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: National Hospital of the Faroe Islands
First posted: 2020-02-13
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in fibrinolytic biomarkers: tissue plasminogen activator (t-PA) and plasminogen activator inhibitor-1 (PAI-1).
timeFrame: 3 months
measure: Changes in clot maximum absorbance using the clot lysis assay.
timeFrame: 3 months
measure: Changes in clot lysis time using the clot lysis assay.
timeFrame: 3 months
measure: Changes in area under the curve using the clot lysis assay.
timeFrame: 3 months
Secondary outcomes:
measure: Changes in platelet aggregation using arachidonic acid (ASPI) as agonist.
timeFrame: 3 months
measure: Changes in platelet aggregation using adenosine diphosphate (ADP) as agonist.
timeFrame: 3 months
measure: Changes in platelet aggregation using thrombin receptor activating peptide-6 (TRAP) as agonist.
timeFrame: 3 months
measure: Changes in thrombin generation assessing lag-time until initial thrombin generation.
timeFrame: 3 months
measure: Changes in thrombin generation assessing maximum concentration of thrombin.
timeFrame: 3 months
measure: Changes in thrombin generation assessing time to peak.
timeFrame: 3 months
measure: Changes in thrombin generation assessing endogenous thrombin potential.
timeFrame: 3 months
measure: Changes in coagulation biomarkers: APTT, INR, Factor VIII, vWF.
timeFrame: 3 months
measure: Changes in inflammatory biomarkers: CRP, multiple interleukins, tumor necrosis factor alpha (TNF-α), interferon gamma (INF-γ) and more.
timeFrame: 3 months
Other outcomes:
measure: Changes in cardiorespiratory performance: maximal oxygen uptake
timeFrame: 3 months
measure: Changes in cardiorespiratory performance: maximal power output
timeFrame: 3 months
measure: Changes in physical health and mental health (quality of life) assessed by the SF-36v2 questionnaire.
timeFrame: 3 months
measure: Incidence of adverse events associated with the exercise intervention.
timeFrame: 3 months
Locations:
city: Tórshavn
country: Faroe Islands
facility: National Hospital of the Faroe Islands
Study officials:
References:
citation: Kristiansen J, Sjuretharson T, Grove EL, Rasmussen J, Kristensen SD, Hvas AM, Mohr M. Feasibility and impact of whole-body high-intensity interval training in patients with stable coronary artery disease: a randomised controlled trial. Sci Rep. 2022 Oct 14;12(1):17295. doi: 10.1038/s41598-022-21655-w.