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

Primary Purpose

Arteriosclerosis, Coronary

Status
Unknown status
Phase
Early Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Exercise, Aerobic (Water based)
Land Group
Sponsored by
Universidade Metodista de Piracicaba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriosclerosis, Coronary focused on measuring Autonomic Nervous System, Body composition, Oxygen Uptake,, Water Based Physical Training, Land Based Physical Training.

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Universidade Metodista de Piracicaba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise, Aerobic (Water based)

Land Group

Arm Description

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

Patients of this group perform physical training on bicycle.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 15, 2014
Last Updated
July 23, 2014
Sponsor
Universidade Metodista de Piracicaba
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1. Study Identification

Unique Protocol Identification Number
NCT02198872
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metodista de Piracicaba

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriosclerosis, Coronary
Keywords
Autonomic Nervous System, Body composition, Oxygen Uptake,, Water Based Physical Training, Land Based Physical Training.

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise, Aerobic (Water based)
Arm Type
Experimental
Arm Description
Patients of this group will be submitted to an aerobic water based physical training
Arm Title
Land Group
Arm Type
Active Comparator
Arm Description
Patients of this group perform physical training on bicycle.
Intervention Type
Other
Intervention Name(s)
Exercise, Aerobic (Water based)
Intervention Description
Patients of this group will be submitted to an aerobic water based physical training
Intervention Type
Other
Intervention Name(s)
Land Group
Intervention Description
Patients of this group perform physical training on bicycle.
Primary Outcome Measure Information:
Title
Change in autonomic system modulation
Description
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.
Time Frame
baseline and 16 weeks
Secondary Outcome Measure Information:
Title
Change in body composition
Description
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.
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Oxygen uptake
Description
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.
Time Frame
16 Weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elie Fiogbé, Ms
Phone
+5519983616077
Email
felie1883@yahoo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elie Fiogbé, Ms
Organizational Affiliation
Universidade Metodista de Piracicaba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Metodista de Piracicaba
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
55
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elie, Fiogbé
Email
felie1883@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Elie Fiogbé, Ms

12. IPD Sharing Statement

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

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