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

November 12, 2017 updated by: Borut Jug, University Medical Centre Ljubljana

Comparative Effect of Water-based and Land-based Exercise Training on Exercise Capacity and Other Selected Cardiovascular Parameters 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Center Ljubljana
      • Novo Mesto, Slovenia, 8000
        • Terme Krka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Water-based exercise training group
Intervention: Patients randomized to the "water-based exercise training group" will undergo water-based exercise training. The immersed exercise will include two session of aerobic (water-based) and calisthenic exercise per day, six days of a week, each lasting 30 minutes.
Other: water-based exercise training
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
ACTIVE_COMPARATOR: Land-based exercise training group
Patients randomized to the "land-based exercise training group" will undergo exercise training which will include two aerobic and calisthenic exercise session per day, six days of a week, lasting 30 minutes
Other: land-based exercise training
Land-based training will include two aerobic and calisthenic exercise session per day, six days of a week, both lasting 30 minutes
NO_INTERVENTION: Control group (usual care)
Control group: patients randomized in control group will have usual care with no exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of maximal oxygen consumption during cardiopulmonary bicycle exercise testing
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of flow-mediated dilation of brachial artery measured in %
Time Frame: 14 days
14 days
Change of arrhythmogenic potential estimated by high resolution ECG
Time Frame: 14 days
14 days
Change of the C-reactive protein serum concentration value, measured in g/l
Time Frame: 14 days
14 days
Change of N terminal - proBNP serum concentration value , measured in ng/l
Time Frame: 14 days
14 days
Change of the D-dimer serum concentration value, measured in microg/l
Time Frame: 14 days
14 days
Change in fibrinogen serum concentration value, measured in g/l
Time Frame: 14 days
14 days
Change of from-the-questionnaire-obtained quality of life, measured in points
Time Frame: 14 days
14 days
Change in heart rate variability, estimated by high resolution ECG
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Collaborators

KRKA

Investigators

  • Study Chair: Borut Jug, MD, PhD, University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (ESTIMATE)

July 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 12, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKCLRehab0012016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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