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

NCT ID: NCT02198872

Last Updated: 2014-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-02-28

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).

Conditions

Arteriosclerosis, Coronary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Exercise, Aerobic (Water based)

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

Group Type: EXPERIMENTAL

Exercise, Aerobic (Water based)

Intervention Type: OTHER

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

Land Group

Patients of this group perform physical training on bicycle.

Group Type: ACTIVE_COMPARATOR

Land Group

Intervention Type: OTHER

Patients of this group perform physical training on bicycle.

Interventions

Exercise, Aerobic (Water based)

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

Intervention Type: OTHER

Land Group

Patients of this group perform physical training on bicycle.

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade Metodista de Piracicaba

OTHER

Sponsor Role: lead

Responsible Party

Elie Fiogbé

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elie Fiogbé, Ms

Role: PRINCIPAL_INVESTIGATOR

Universidade Metodista de Piracicaba

Locations

Universidade Metodista de Piracicaba

Piracicaba, São Paulo, Brazil

Countries

Brazil

Central Contacts

Elie Fiogbé, Ms

Role: CONTACT

felie1883@yahoo.fr

+5519983616077

Facility Contacts

Elie, Fiogbé

Role: primary

felie1883@yahoo.fr

Other Identifiers

190729/2011-2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

03/13

Identifier Type: -

Identifier Source: org_study_id