Aquatic and Land Aerobic Training, Cardiorespiratory and Metabolic Variables in Cardiorespiratory Diseases

Universidade Metodista de Piracicaba

Status and phase: Unknown; Early Phase 1

Conditions: Arteriosclerosis, Coronary

Treatments: Other: Land Group; Other: Exercise, Aerobic (Water based)

Study type: Interventional

Funder types: Other

Identifiers

NCT02198872

03/13

190729/2011-2 (Other Grant/Funding Number)

Details and patient eligibility

About

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%.

Full 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).

Enrollment: 40 estimated patients

Sex: Male

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Exercise, Aerobic (Water based)

Experimental group

Description:

Patients of this group will be submitted to an aerobic water based physical training

Treatment:

Other: Exercise, Aerobic (Water based)

Land Group

Active Comparator group

Description:

Patients of this group perform physical training on bicycle.

Treatment:

Other: Land Group