Clinical trial NCT02198872: Aquatic and Land Aerobic Training, Cardiorespiratory and Metabolic Variables in Cardiorespiratory Diseases
Official title: Effects of Aquatic and Land Aerobic Training on Body Composition and Cardiorespiratory and Metabolic Variables in Patients With Cardiorespiratory Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Arteriosclerosis, Coronary
Keywords: Autonomic Nervous System, Body composition, Oxygen Uptake,
Water Based Physical Training, Land Based Physical Training.
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 40
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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%.

Detailed description: 1. 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.
2. 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.
3. After this assessment, the volunteers will be randomly assigned to one of two groups, aerobic water (WPT) or land (LPT) based physical training.
4. 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).

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

Primary outcomes:
measure: Change in autonomic system modulation
timeFrame: baseline and 16 weeks
Secondary outcomes:
measure: Change in body composition
timeFrame: 16 weeks
Other outcomes:
measure: Oxygen uptake
timeFrame: 16 Weeks
Locations:
city: Piracicaba
country: Brazil
facility: Universidade Metodista de Piracicaba
state: São Paulo
Study officials:
affiliation: Universidade Metodista de Piracicaba
name: Elie Fiogbé, Ms
role: PRINCIPAL_INVESTIGATOR
References: