- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02211573
Aquatic Aerobic Training, Cardiorespiratory and Metabolic Variables in Coronary Artery Disease
Effects of Aquatic Aerobic Training on Body Composition and Cardiorespiratory and Metabolic Variables in Patients With Coronary Artery Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
São Paulo
-
Piracicaba, São Paulo, Brazil, 55
- Universidade Metodista de Piracicaba
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
Patients of this group don't performed physical training
|
|
Experimental: Exercise, Aerobic (Water based)
Patients of this group were submitted to an aerobic water based physical training
|
Patients of this group were submitted to an aerobic water based physical training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in autonomic system modulation
Time Frame: baseline and 16 weeks
|
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.
|
baseline and 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body composition
Time Frame: baseline and 16 weeks
|
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.
|
baseline and 16 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygen uptake
Time Frame: 16 Weeks
|
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.
|
16 Weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03/14
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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