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

NCT ID: NCT04268992

Last Updated: 2023-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-03

Study Completion Date

2023-01-16

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Exercise Inflammation Hemostasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Long-term exercise

Supervised exercise training three times a week for three months.

Group Type EXPERIMENTAL

Long-term exercise

Intervention Type 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.

Usual care

Patients are not offered supervised exercise.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Hospital of the Faroe Islands

OTHER_GOV

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jacobina Kristiansen

M.D., PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Hospital of the Faroe Islands

Tórshavn, , Faroe Islands

Site Status

Countries

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Faroe Islands

References

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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.

Reference Type DERIVED
PMID: 37880303 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36428083 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36241898 (View on PubMed)

Other Identifiers

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1-16-02-408-19

Identifier Type: -

Identifier Source: org_study_id

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