Aquatic Aerobic Training, Cardiorespiratory and Metabolic Variables in Coronary Artery Disease
Primary Purpose
Arteriosclerosis, Coronary
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise, Aerobic (Water based)
Sponsored by
About this trial
This is an interventional treatment trial for Arteriosclerosis, Coronary focused on measuring Autonomic Nervous System, Body composition, Oxygen Uptake,, Water Based Physical Training.
Eligibility Criteria
Inclusion Criteria:
- diagnosis by angiography
- sedentaries
- family story of cardiac disease
- obesity
Exclusion Criteria:
- frequent arrhythmias at rest
- triggered by physical effort
- unstable angina
- chronic obstructive pulmonary disease
- insulin-dependent diabet
- renal failure
- sequel of stroke
- uncontrolled hypothyroidism
- water phobia
- skin infections, allergic reactions to chlorine,
- urinary incontinence and
- musculoskeletal and neuromuscular disorders precluding physical tests and training sessions
Sites / Locations
- Universidade Metodista de Piracicaba
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Exercise, Aerobic (Water based)
Arm Description
Patients of this group don't performed physical training
Patients of this group were submitted to an aerobic water based physical training
Outcomes
Primary Outcome Measures
Change in autonomic system modulation
Change in autonomic system modulation in assess by comparing the heart rate variability at baseline and after a 16 weeks of aerobic water and land based physical training.
Secondary Outcome Measures
Change in body composition
Change in body composition is assess by comparing the body composition at baseline and after a 16 weeks of aerobic water and land based physical training.
Full Information
NCT ID
NCT02211573
First Posted
August 5, 2014
Last Updated
August 5, 2014
Sponsor
Universidade Metodista de Piracicaba
1. Study Identification
Unique Protocol Identification Number
NCT02211573
Brief Title
Aquatic Aerobic Training, Cardiorespiratory and Metabolic Variables in Coronary Artery Disease
Official Title
Effects of Aquatic Aerobic Training on Body Composition and Cardiorespiratory and Metabolic Variables in Patients With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metodista de Piracicaba
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Although approaches to reduce cardiovascular disease, coronary artery disease (CAD) remains the leading cause of mortality in the industrialized world. In order to reduce the deleterious effects of the atherosclerotic process, proposals for non-pharmacological treatment have been used, such as cardiac rehabilitation programs, with emphasis on exercise -based therapy. Traditionally aerobic exercises like biking, walking and jogging are conducted, however, alternative ways such as aquatic exercise training have been proposed, however, the cardiorespiratory adaptations in this population are not well documented in the literature. Thus, the aim of this study was to evaluate the effects of aquatic aerobic training (AAT) on body composition, autonomic modulation of heart rate (HR) and cardiorespiratory and metabolic variables in patients with CAD. This was a longitudinal clinical trial with a sample allocated for convenience, in which twenty-one patients were male, with a diagnosis of CAD, which were divided into control group (CG were studied, n=8), who was only assessed, and training group (TG, n=13). All patients underwent assessment of body composition, heart rate variability (HRV) at rest in the supine posture, and cardiopulmonary exercise testing (CPET), performed before and after the AAT program. The training protocol consisted of three sessions per week on alternate days for 16 weeks, totaling 48 sessions, which had lasted approximately one hour. The exercise intensity was prescribed between 80 and 110% of the first ventilatory threshold (VT1) obtained in CPET. Given that these parameters represent risk markers for cardiovascular events in the population studied, the results suggest that the AAT proposed in this study may be an important therapeutic strategy to be incorporated into cardiac rehabilitation programs.
Detailed Description
Personal Data recording:
History: personal data, lifestyle and food, family history, current and previous history of disease.
Physical examination: cardiac and lung auscultation,measurement of heart rate (HR), blood pressure (BP), body weight and height.
Assessments:
All experimental procedures were performed in the morning in order to minimize the influence of circadian cycle. The temperature of the experimental room was maintained between 22 ° C and 24 ° C with relative humidity between 40% and 60%. Patients were familiarized with the experimental protocol, and instructed not to ingest stimulant drinks such as coffee, tea and soft drinks, do not drink alcohol, do not perform strenuous exercise (48 hours before surgery), and to perform a light meal at least four hours before the collections.
Aiming to verify if the baseline conditions were suitable for the beginning of the experimental procedures, the patients remained 15 minutes of rest in the supine position, and recorded blood pressure (BP) and HR.
After this, were performed:
Analysis of body composition by bioelectrical impedance analysis.
Registration of HR and NN intervals (NN) during rest, in the supine and sitting positions.
Recording of HR and NN during rest in the supine position, sitting, standing and during respiratory sinus arrhythmia maneuver.
Spirometric test and
Cardiopulmonary exercise test (CPET). This is a submaximal CPET performed on a treadmill, in order to verify and identify possible changes in hemodynamic, electrocardiographic induced to physical exertion, their aerobic functional capacity as well as to prescribe physical training protocol.
Training:
After this assessment the volunteers were trained by a aerobic water based physical training program for 4 weeks.
Second assessment:
Components of the first assessment have been repeated at the end of each month of physical training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriosclerosis, Coronary
Keywords
Autonomic Nervous System, Body composition, Oxygen Uptake,, Water Based Physical Training.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients of this group don't performed physical training
Arm Title
Exercise, Aerobic (Water based)
Arm Type
Experimental
Arm Description
Patients of this group were submitted to an aerobic water based physical training
Intervention Type
Other
Intervention Name(s)
Exercise, Aerobic (Water based)
Intervention Description
Patients of this group were submitted to an aerobic water based physical training
Primary Outcome Measure Information:
Title
Change in autonomic system modulation
Description
Change in autonomic system modulation in assess by comparing the heart rate variability at baseline and after a 16 weeks of aerobic water and land based physical training.
Time Frame
baseline and 16 weeks
Secondary Outcome Measure Information:
Title
Change in body composition
Description
Change in body composition is assess by comparing the body composition at baseline and after a 16 weeks of aerobic water and land based physical training.
Time Frame
baseline and 16 weeks
Other Pre-specified Outcome Measures:
Title
Oxygen uptake
Description
Change in oxygen uptake is assessed by comparing the oxygen uptake at baseline and after a 16 weeks of aerobic water and land based physical training.
Time Frame
16 Weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis by angiography
sedentaries
family story of cardiac disease
obesity
Exclusion Criteria:
frequent arrhythmias at rest
triggered by physical effort
unstable angina
chronic obstructive pulmonary disease
insulin-dependent diabet
renal failure
sequel of stroke
uncontrolled hypothyroidism
water phobia
skin infections, allergic reactions to chlorine,
urinary incontinence and
musculoskeletal and neuromuscular disorders precluding physical tests and training sessions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elie Fiogbé, Ms
Organizational Affiliation
Universidade Metodista de Piracicaba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Metodista de Piracicaba
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
55
Country
Brazil
12. IPD Sharing Statement
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Aquatic Aerobic Training, Cardiorespiratory and Metabolic Variables in Coronary Artery Disease
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