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

NCT04268992 | Completed

• 1 other identifier: 1-16-02-408-19
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Exercise; Inflammation; Hemostasis

Keywords

Cardiovascular Diseases; Exercise; Hemostasis; Inflammation

Outcome Measures

Primary Outcomes (4)

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

  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.

  3 months

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

  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 months

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

  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.

  3 months

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

  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.

  3 months

Secondary Outcomes (9)

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

  3 months

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

  3 months

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

  3 months

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

  3 months

• Changes in thrombin generation assessing maximum concentration of thrombin.

  3 months

Other Outcomes (4)

• Changes in cardiorespiratory performance: maximal oxygen uptake

  3 months

• Changes in cardiorespiratory performance: maximal power output

  3 months

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

  3 months

Study Arms (2)

Long-term exercise

EXPERIMENTAL

Supervised exercise training three times a week for three months.

Other: Long-term exercise

Usual care

NO INTERVENTION

Patients are not offered supervised exercise.

Interventions

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.

Long-term exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• National Hospital of the Faroe Islands: collaborator

Study Sites (1)

National Hospital of the Faroe Islands

Tórshavn, 100, Faroe Islands

Location

Related Publications (4)

• Kristiansen J, Kristensen SD, Hvas AM, Ellingsgaard H, Mohr M, Grove EL, Sjuretharson T. Effects of Acute Exercise and 12-Week High-Intensity Interval Training on Inflammatory Biomarkers in Stable Coronary Artery Disease: A Randomized Controlled Trial. J Am Heart Assoc. 2026 Feb 3:e042256. doi: 10.1161/JAHA.125.042256. Online ahead of print.

  PMID: 41631762 DERIVED

• Sjuretharson T, Kristiansen J, Nordsborg NB, Gregersen NO, Lydersen LN, Grove EL, Kristensen SD, Hvas AM, Mohr M. The angiotensin-converting enzyme I/D polymorphism does not impact training-induced adaptations in exercise capacity in patients with stable coronary artery disease. Sci Rep. 2023 Oct 25;13(1):18300. doi: 10.1038/s41598-023-45542-0.

  PMID: 37880303 DERIVED

• Kristiansen J, Grove EL, Sjuretharson T, Rasmussen J, Mohr M, Kristensen SD, Hvas AM. Haemostasis and fibrinolysis after regular high-intensity interval training in patients with coronary artery disease: a randomised controlled trial. Open Heart. 2022 Nov;9(2):e002127. doi: 10.1136/openhrt-2022-002127.

  PMID: 36428083 DERIVED

• 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.

  PMID: 36241898 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Motor Activity; Inflammation; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD-student

Model Details: A randomized controlled trial

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 13, 2020
• Study Start: July 3, 2020
• Primary Completion: June 4, 2021
• Study Completion: January 16, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

FA (1)