Ignite Creation Date:
2024-05-06 @ 3:03 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02198872
Status:
UNKNOWN
Last Update Posted:
2014-07-24
First Post:
2014-07-15
Brief Title:
Aquatic and Land Aerobic Training Cardiorespiratory and Metabolic Variables in Cardiorespiratory Diseases
Sponsor:
Universidade Metodista de Piracicaba
Organization:
Universidade Metodista de Piracicaba
Study Overview
Official Title:
Effects of Aquatic and Land Aerobic Training on Body Composition and Cardiorespiratory and Metabolic Variables in Patients With Cardiorespiratory Diseases
Status:
UNKNOWN
Status Verified Date:
2014-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 auscultationmeasurement 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
History personal data lifestyle and food family history current and previous history of disease
Physical examination cardiac and lung auscultationmeasurement 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1907292011-2 | OTHER_GRANT | 1907292011-2 | None |