Effects of Two Aquatic Training Models in Physiological Parameters of Elderly Dyslipidemic Women.

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the effects of two water-based training models in physiological parameters of dyslipidemic elderly women. Thus, a randomized controlled clinical trial will be conducted in parallel with the participation of 45 dyslipidemic elderly women.

Detailed Description
-----------------
The women will be randomly divided into three groups: water aerobics training (WA), resistance aquatic training (WR) and the third is the control group (who will perform relaxation sessions under water). The three groups will attend classes during 10 weeks, with two weekly sessions of 45 minutes each. The WA and WR groups will use the same four exercises in their training. The WA group will be trained using the interval method, performing six blocks of five minutes each one, alternating four minutes at intensities corresponding to 90 to 100% of the heart rate corresponding to the second ventilatory threshold (HRVT2) and one minute at intensities between 80 and 90% HRVT2. The WR group will perform four to eight sets of 20 to 10 seconds along the macrocycle, always at maximal speed execution of the exercises. Will be measured, before and after the period of 10 weeks of intervention, biochemical, cardiorespiratory, neuromuscular and hemodynamic variables, parameters of quality of life and depressive symptoms in addition to the cardiovascular risk score of the participants of the three groups. Data will be described by means values and lower and upper limits, with a 95% confidence interval. Comparisons between and within groups were performed using the method of generalized estimates of equations (GEE), with Bonferroni post hoc, adopting a 0.05 significance level.

Official Title
-----------------
Effects of Two Aquatic Training Models in Physiological Parameters of Elderly Dyslipidemic Women: a Randomized Controlled Clinical Trial.

Conditions
-----------------
Dyslipidemias

Intervention / Treatment
-----------------
* Other: Water aerobics training.
* Other: Water resistance training.
* Other: Control Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being female, aged between 60 and 75, sedentary (not practicing any kind of regular, supervised physical activity in the last three months), have any type of dyslipidemia. Exclusion Criteria: women who are smokers, suffering from cardiovascular disease with associated complications and those with orthopedic diseases that prevented the practice of systematic physical exercise, users of hormone therapy drugs and lipid-lowering medications.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WA (Water Aerobics Training)<br>Water aerobics training. | Other: Water aerobics training.<br>* The WA group will be trained adopting the interval method, performing six blocks of five minutes each one, alternating four minutes at intensities corresponding to 90 to 100% of the heart rate corresponding to the second ventilatory threshold (HRVT2) and one minute at intensities between 80 and 90% HRVT2.<br>* Other names: WA;|
| Experimental: WR (Water Resistance Training)<br>Resistance aquatic training. | Other: Water resistance training.<br>* The WR group will perform four to eight sets of 20 to 10 seconds along the macrocycle, always at maximal speed execution of the exercises.<br>* Other names: WR;|
| Active Comparator: CG (Control Group)<br>Control Group. | Other: Control Group<br>* The control group will perform relaxation classes, including meditation, balance exercises, coordination exercises.<br>* Other names: CG;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol (TC) Change | This variable will be measured through blood collection after 12 hours fasting. The analysis will be performed through the enzymatic method using kits Siemens, in automated equipment Advia 1800. | Change from baseline total cholesterol at 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides (TG) Change | This variable will be measured through blood collection after 12 hours fasting. The analysis will be performed through the enzymatic method using kits Siemens, in automated equipment Advia 1800. | Change from baseline triglycerides at 10 weeks | 
| High Density Lipoprotein (HDL) Change | This variable will be measured through blood collection after 12 hours fasting. The analysis will be performed through the enzymatic method using kits Siemens, in automated equipment Advia 1800. | Change from baseline HDL at 10 weeks | 
| C-Reactive Protein (CRP) Change | This variable will be measured through blood collection after 12 hours fasting. The analysis will be performed through the turbidimetric method in Cobas Mira Plus equipment, with the Biotechnical Kit for ultrasensitive C-reactive protein. | Change from baseline C-reactive protein at 10 weeks | 
| Low Density Lipoprotein (LDL) Change | This variable will be estimated by Friedewald equation. | Change from baseline LDL at 10 weeks | 
| Total Cholesterol/High Density Lipoprotein Ratio (TC/HDL ratio) Change | This variable will be estimated by the simple division of variables. | Change from baseline TC/HDL at 10 weeks | 
| Peak Oxygen Consumption (VO2peak) Change | This outcome will be measure through maximal progressive treadmill test, using the portable gas analyser VO2000 equipment. | Change from baseline VO2peak at 10 weeks | 
| Oxygen Consumption at anaerobic threshold (VO2VT2) Change | This outcome will be measure through maximal progressive treadmill test, using the portable gas analyser VO2000 equipment. | Change from baseline VO2VT2 at 10 weeks | 
| Heart Rate at anaerobic threshold (HRVT2) Change | This outcome will be measure through maximal progressive treadmill test, using a heart rate monitor (POLAR, FT1). | Change from baseline HRVT2 at 10 weeks | 
| Rest Heart Rate (HRrest) Change | This outcome will be measure using a heart rate monitor (POLAR, FT1). The participants will remain seated in a quiet and controlled temperature room during 15 minutes prior to measurement of the heart rate. | Change from baseline HRrest at 10 weeks | 
| Lipoprotein Lipase (LPL) Change | This variable will be measured through blood collection after 12 hours fasting. The analysis will be performed using the LPL ELISA kit (Cell Biolabs). The results will be read in a microplate reader (ELISA). | Change from baseline LPL at 10 weeks | 
| Maximal dynamic muscle strength of knees extensors (MSKE) Change | This outcome will be measured through the one-repetition maximal test (1RM). | Change from baseline MSKE at 10 weeks | 
| Maximal dynamic muscle strength of knees flexors (MSKF) Change | This outcome will be measured through the one-repetition maximal test (1RM). | Change from baseline MSKF at 10 weeks | 
| Maximal dynamic muscle strength of horizontal shoulder flexors (MSHSF) Change | This outcome will be measured through the one-repetition maximal test (1RM). | Change from baseline MSHSF at 10 weeks | 
| Rest Cardiac Output (COrest) Change | This outcome will be measured through Impedance Cardiography (Physioflow Lab-1 equipment). The participants will remain seated in a quiet and controlled temperature room during 15 minutes prior to measurement of the cardiac output. | Change from baseline COrest at 10 weeks | 
| Rest Stroke Volume (SVrest) Change | This outcome will be measured through Impedance Cardiography (Physioflow Lab-1 equipment). The participants will remain seated in a quiet and controlled temperature room during 15 minutes prior to measurement of the stroke volume. | Change from baseline SVrest at 10 weeks | 
| Peak Cardiac Output (COpeak) Change | This outcome will be measured through Impedance Cardiography (Physioflow Lab-1 equipment), during a maximal progressive treadmill test. | Change from baseline COpeak at 10 weeks | 
| Peak Stroke Volume (SVpeak) Change | This outcome will be measured through Impedance Cardiography (Physioflow Lab-1 equipment), during a maximal progressive treadmill test. | Change from baseline SVpeak at 10 weeks | 
| Rest Arterial Systolic Blood Pressure (SBPrest) Change | This outcome will be measured through blood pressure ambulatory monitor (Meditech, ABPM-04). The participants will remain seated in a quiet and controlled temperature room during 15 minutes prior to measurement of the arterial systolic blood pressure. | Change from baseline SBPrest at 10 weeks | 
| Rest Arterial Diastolic Blood Pressure (DBPrest) Change | This outcome will be measured through blood pressure ambulatory monitor (Meditech, ABPM-04). The participants will remain seated in a quiet and controlled temperature room during 15 minutes prior to measurement of the arterial diastolic blood pressure. | Change from baseline DBPrest at 10 weeks | 
| Cardiovascular Risk Score (CRS) Change | The Reynolds Risk Score Instrument will be used to estimate the cardiovascular risk. | Change from baseline cardiovascular risk score at 10 weeks | 
| Quality of Life Change | The quality of life will be estimated using the Whoqol-Bref instrument. | Change from baseline quality of life at 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dyslipidemias,, aging, water aerobics training, resistance aquatic training, lipid profile