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

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02900612
• Other study ID #: 14-0547
• Status: Completed
• Phase: N/A
• First received: September 6, 2016
• Last updated: September 9, 2016
• Start date: December 2015
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Other:
• Water aerobics training.
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.
• Water resistance training.
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.
• Control Group
The control group will perform relaxation classes, including meditation, balance exercises, coordination exercises.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Low Density Lipoprotein (LDL) Change	This variable will be estimated by Friedewald equation.	Change from baseline LDL at 10 weeks	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes