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

Arteriosclerosis, Coronary Clinical Trial

Official title:

Effects of Aquatic and Land Aerobic Training on Body Composition and Cardiorespiratory and Metabolic Variables in Patients With Cardiorespiratory Diseases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02198872
• Other study ID #: 03/13
• Secondary ID: 190729/2011-2
• Status: Not yet recruiting
• Phase: Phase 0
• First received: July 15, 2014
• Last updated: July 23, 2014
• Start date: September 2014
• Est. completion date: February 2018

Study information

• Verified date: July 2014
• Source: Universidade Metodista de Piracicaba
• Contact: Elie Fiogbé, Ms
• Phone: +5519983616077
• Email: felie1883[@]yahoo.fr
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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%.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 2018
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Arteriosclerosis, Coronary
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Other:
• Exercise, Aerobic (Water based)
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.

Locations

Country	Name	City	State
Brazil	Universidade Metodista de Piracicaba	Piracicaba	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Metodista de Piracicaba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oxygen uptake	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	Yes
Primary	Change in autonomic system modulation	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	Yes
Secondary	Change in body composition	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	Yes

External Links

•   Land versus water exercise in patients with coronary artery disease: effects on body composition, blood lipids, and physical fitness