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Completed

NCT Number: NCT02831829

Influence of Different Forms of Exercise Training in Patients With Coronary Artery Disease

The aim of the study is to compare the effect of water-based and land-based exercise training, and usual care (no exercise training) in patient with coronary artery disease, on exercise capacity, vascular function, arrhythmogenic potential and cardiac autonomic function, and markers of neurohormonal activity, activated hemostasis and inflammation.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University medical center Ljubljana, Ljubljana, Slovenia

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About this study

Swimming and other water-based physical activities represent an effective form of aerobic-dynamic exercise. However, existing guidelines mainly advise caution when recommending water-based activities to patients with coronary artery disease. To date, safety and efficacy of short-term water-based exercise in patients with coronary artery diseases have only scarcely been addressed.

Cardiovascular rehabilitation is an integral part of management after a myocardial infarction or coronary procedure. Most rehabilitation programs are exercise-based, since the beneficial effects of physical activity undisputed, and corroborated by a large body of evidence.

Most rehabilitation programs are exercise-based, since the beneficial effects of physical activity undisputed, and corroborated by a large body of evidence.

Research has mainly been focused on the impact assessment of the standard forms of physical training, they studied various forms of physical exercise, mainly land-based. No previous study has reported on the effect of exercise in water as an integral element of standard cardiac rehabilitation in coronary patients on exercise capacity, vascular function, arrhythmogenic potential and cardiac autonomic function, and markers of neurohormonal activity, activated hemostasis and inflammation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with coronary artery disease after myocardial infarction or myocardial revascularization (percutaneous coronary procedure or surgical revascularization)

Exclusion criteria

  • unstable coronary artery disease, ejection fraction of the left ventricle of 40% or less, heart valve defect that dictate specific treatment, condition after valve replacement, heart rhythm disorders, the presence of a permanent pacemaker, contraindications to exercise, inability to perform exercise testing, mental retardation, severe anemia, obstructive/restrictive lung disease severe degree, recent thrombo embolic events, age over 80 years.

Treatment and study plan

water-based exercise training

Other

Water-based training will be performed in upright position, in waist to xyphoid process deep thermo-neutral water at temperature of 32,8 C. The immersed exercise will include two session of aerobic and calisthenic exercise per day, six days of a week, both lasting 30 minutes

land-based exercise training

Other

Land-based training will include two aerobic and calisthenic exercise session per day, six days of a week, both lasting 30 minutes

Primary outcomes

  1. Change of maximal oxygen consumption during cardiopulmonary bicycle exercise testing

    Time frame: 14 days

Secondary outcomes

  1. Change of flow-mediated dilation of brachial artery measured in %

    Time frame: 14 days

  2. Change of arrhythmogenic potential estimated by high resolution ECG

    Time frame: 14 days

  3. Change of the C-reactive protein serum concentration value, measured in g/l

    Time frame: 14 days

  4. Change of N terminal - proBNP serum concentration value , measured in ng/l

    Time frame: 14 days

  5. Change of the D-dimer serum concentration value, measured in microg/l

    Time frame: 14 days

  6. Change in fibrinogen serum concentration value, measured in g/l

    Time frame: 14 days

  7. Change of from-the-questionnaire-obtained quality of life, measured in points

    Time frame: 14 days

  8. Change in heart rate variability, estimated by high resolution ECG

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • KRKA

Registry information

Official study title

Comparative Effect of Water-based and Land-based Exercise Training on Exercise Capacity and Other Selected Cardiovascular Parameters in Patients With Coronary Artery Disease

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jul 13, 2016
Registry last updated
Nov 14, 2017

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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