- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02198872
Aquatic and Land Aerobic Training, Cardiorespiratory and Metabolic Variables in Cardiorespiratory Diseases
July 23, 2014 updated by: Elie Fiogbé, Universidade Metodista de Piracicaba
Effects of Aquatic and Land Aerobic Training on Body Composition and Cardiorespiratory and Metabolic Variables in Patients With Cardiorespiratory Diseases
In the pathophysiological process of coronary artery disease (CAD), are present, autonomic dysfunction and reduced functional capacity.
Studies showed that physical training (PT) is critical in the treatment of CAD by promoting beneficial effects.
Although water based exercises program have been documented in patients with various cardiovascular diseases, the most of studies among patients with CAD used land based exercises programs.
OBJECTIVE: To evaluate and compare the effects of aerobic water (WPT) and land (LPT) based PT on autonomic modulation of heart rate (HR), body composition and cardiorespiratory and metabolic variables in patients with CAD.
METHODS : 40 men between 50 and 70 years old with CAD diagnosed by coronary angiography showing obstruction greater than 50% and underwent angioplasty will be evaluated in 4 stages; 1) immediately after angioplasty, clinical assessment, body composition analysis and recording of HR and NN intervals during rest.
2) The components of step 1) will be repeated after three month, adding the record of HR and NN before, during and after the Valsalva maneuver, spirometry and cardiopulmonary exercise testing.
3) Volunteers will be randomly divided into two groups, WPT and LPT for 48 sessions.
4) The components of step 2) are repeated after each period of 12 sessions.
Thus, it is expected that WPT promote beneficial physiological adaptations in CAD patients with obstruction greater than 50%.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Immediately after angioplasty, the volunteers will be subject to an assessment (Assessment 0), which will consist of:
- 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.
- Analysis of body composition by bioelectrical impedance analysis.
- Registration of HR and NN intervals (NN) during rest, in the supine and sitting positions.
- biochemical blood tests: complete blood count, blood glucose, total cholesterol, LDL and HDL cholesterol, triglycerides, and C-reactive protein ultrasensitive.
- Recording of HR and NN during rest in the supine position, sitting, standing and during respiratory sinus arrhythmia maneuver.
- Three months after the "Assessment 0", the volunteers will be subject to an assessment (initial Assessment) prior to physical training program. Will be repeated all assessments performed in the "Assessment 0" plus the record of HR and R-Ri before, during and after the Valsalva maneuver, spirometry 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.
- After this assessment, the volunteers will be randomly assigned to one of two groups, aerobic water (WPT) or land (LPT) based physical training.
- Components of "Initial Assessment" will be repeated at the end of each month of physical training (Revaluation 1, 2 and 3) and the end (Final Assessment).
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Early Phase 1
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
-
-
São Paulo
-
Piracicaba, São Paulo, Brazil, 55
- Universidade Metodista de Piracicaba
-
-
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
50 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
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
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: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Exercise, Aerobic (Water based)
Patients of this group will be submitted to an aerobic water based physical training
|
Patients of this group will be submitted to an aerobic water based physical training
|
|
ACTIVE_COMPARATOR: Land Group
Patients of this group perform physical training on bicycle.
|
Patients of this group perform physical training on bicycle.
|
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: 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.
|
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
This is where you will find people and organizations involved with this study.
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
September 1, 2014
Primary Completion (ANTICIPATED)
July 1, 2015
Study Completion (ANTICIPATED)
February 1, 2018
Study Registration Dates
First Submitted
July 15, 2014
First Submitted That Met QC Criteria
July 23, 2014
First Posted (ESTIMATE)
July 24, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
July 24, 2014
Last Update Submitted That Met QC Criteria
July 23, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03/13
- 190729/2011-2 (OTHER_GRANT: 190729/2011-2)
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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