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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02831829
• Date of registration: 11/07/2016
• Prospective Registration: No
• Primary sponsor: University Medical Centre Ljubljana
• Public title: Influence of Different Forms of Exercise Training in Patients With Coronary Artery Disease
• Scientific 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
• Date of first enrolment: May 2016
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02831829
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Slovenia

Contacts

• Name: Borut Jug, MD, PhD
• Affiliation: University Medical Centre Ljubljana

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Intervention(s)

Other: land-based exercise training

Other: water-based exercise training

Primary Outcome(s)

Change of maximal oxygen consumption during cardiopulmonary bicycle exercise testing [Time Frame: 14 days]

Secondary Outcome(s)

Change of arrhythmogenic potential estimated by high resolution ECG [Time Frame: 14 days]

Change of from-the-questionnaire-obtained quality of life, measured in points [Time Frame: 14 days]

Change in fibrinogen serum concentration value, measured in g/l [Time Frame: 14 days]

Change in heart rate variability, estimated by high resolution ECG [Time Frame: 14 days]

Change of flow-mediated dilation of brachial artery measured in % [Time Frame: 14 days]

Change of the C-reactive protein serum concentration value, measured in g/l [Time Frame: 14 days]

Change of N terminal - proBNP serum concentration value , measured in ng/l [Time Frame: 14 days]

Change of the D-dimer serum concentration value, measured in microg/l [Time Frame: 14 days]

Secondary ID(s)

UKCLRehab0012016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

KRKA