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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
water-based exercise training
land-based exercise training
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring cardiac rehabilitation, coronary artery disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University medical center Ljubljana
  • Terme Krka

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Water-based exercise training group

Land-based exercise training group

Control group (usual care)

Arm Description

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.

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

Control group: patients randomized in control group will have usual care with no exercise

Outcomes

Primary Outcome Measures

Change of maximal oxygen consumption during cardiopulmonary bicycle exercise testing

Secondary Outcome Measures

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

Full Information

First Posted
July 11, 2016
Last Updated
November 12, 2017
Sponsor
University Medical Centre Ljubljana
Collaborators
KRKA
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1. Study Identification

Unique Protocol Identification Number
NCT02831829
Brief Title
Influence of Different Forms of Exercise Training in Patients With Coronary Artery Disease
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
Collaborators
KRKA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
cardiac rehabilitation, coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water-based exercise training group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Land-based exercise training group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control group (usual care)
Arm Type
No Intervention
Arm Description
Control group: patients randomized in control group will have usual care with no exercise
Intervention Type
Other
Intervention Name(s)
water-based exercise training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
land-based exercise training
Intervention Description
Land-based training will include two aerobic and calisthenic exercise session per day, six days of a week, both lasting 30 minutes
Primary Outcome Measure Information:
Title
Change of maximal oxygen consumption during cardiopulmonary bicycle exercise testing
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Change of flow-mediated dilation of brachial artery measured in %
Time Frame
14 days
Title
Change of arrhythmogenic potential estimated by high resolution ECG
Time Frame
14 days
Title
Change of the C-reactive protein serum concentration value, measured in g/l
Time Frame
14 days
Title
Change of N terminal - proBNP serum concentration value , measured in ng/l
Time Frame
14 days
Title
Change of the D-dimer serum concentration value, measured in microg/l
Time Frame
14 days
Title
Change in fibrinogen serum concentration value, measured in g/l
Time Frame
14 days
Title
Change of from-the-questionnaire-obtained quality of life, measured in points
Time Frame
14 days
Title
Change in heart rate variability, estimated by high resolution ECG
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Borut Jug, MD, PhD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Study Chair
Facility Information:
Facility Name
University medical center Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Terme Krka
City
Novo Mesto
ZIP/Postal Code
8000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
Yes
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19952757
Citation
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Influence of Different Forms of Exercise Training in Patients With Coronary Artery Disease

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