Effects of Two Aquatic Training Models in Physiological Parameters of Elderly Dyslipidemic Women.
Primary Purpose
Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Water aerobics training.
Water resistance training.
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias focused on measuring dyslipidemias,, aging, water aerobics training, resistance aquatic training, lipid profile
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
WA (Water Aerobics Training)
WR (Water Resistance Training)
CG (Control Group)
Arm Description
Water aerobics training.
Resistance aquatic training.
Control Group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Low Density Lipoprotein (LDL) Change
This variable will be estimated by Friedewald equation.
Total Cholesterol/High Density Lipoprotein Ratio (TC/HDL ratio) Change
This variable will be estimated by the simple division of variables.
Peak Oxygen Consumption (VO2peak) Change
This outcome will be measure through maximal progressive treadmill test, using the portable gas analyser VO2000 equipment.
Oxygen Consumption at anaerobic threshold (VO2VT2) Change
This outcome will be measure through maximal progressive treadmill test, using the portable gas analyser VO2000 equipment.
Heart Rate at anaerobic threshold (HRVT2) Change
This outcome will be measure through maximal progressive treadmill test, using a heart rate monitor (POLAR, FT1).
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.
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).
Maximal dynamic muscle strength of knees extensors (MSKE) Change
This outcome will be measured through the one-repetition maximal test (1RM).
Maximal dynamic muscle strength of knees flexors (MSKF) Change
This outcome will be measured through the one-repetition maximal test (1RM).
Maximal dynamic muscle strength of horizontal shoulder flexors (MSHSF) Change
This outcome will be measured through the one-repetition maximal test (1RM).
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.
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.
Peak Cardiac Output (COpeak) Change
This outcome will be measured through Impedance Cardiography (Physioflow Lab-1 equipment), during a maximal progressive treadmill test.
Peak Stroke Volume (SVpeak) Change
This outcome will be measured through Impedance Cardiography (Physioflow Lab-1 equipment), during a maximal progressive treadmill test.
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.
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.
Cardiovascular Risk Score (CRS) Change
The Reynolds Risk Score Instrument will be used to estimate the cardiovascular risk.
Quality of Life Change
The quality of life will be estimated using the Whoqol-Bref instrument.
Full Information
NCT ID
NCT02900612
First Posted
September 6, 2016
Last Updated
September 9, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02900612
Brief Title
Effects of Two Aquatic Training Models in Physiological Parameters of Elderly Dyslipidemic Women.
Official Title
Effects of Two Aquatic Training Models in Physiological Parameters of Elderly Dyslipidemic Women: a Randomized Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
Keywords
dyslipidemias,, aging, water aerobics training, resistance aquatic training, lipid profile
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WA (Water Aerobics Training)
Arm Type
Experimental
Arm Description
Water aerobics training.
Arm Title
WR (Water Resistance Training)
Arm Type
Experimental
Arm Description
Resistance aquatic training.
Arm Title
CG (Control Group)
Arm Type
Active Comparator
Arm Description
Control Group.
Intervention Type
Other
Intervention Name(s)
Water aerobics training.
Other Intervention Name(s)
WA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Water resistance training.
Other Intervention Name(s)
WR
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Other Intervention Name(s)
CG
Intervention Description
The control group will perform relaxation classes, including meditation, balance exercises, coordination exercises.
Primary Outcome Measure Information:
Title
Total Cholesterol (TC) Change
Description
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.
Time Frame
Change from baseline total cholesterol at 10 weeks
Secondary Outcome Measure Information:
Title
Triglycerides (TG) Change
Description
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.
Time Frame
Change from baseline triglycerides at 10 weeks
Title
High Density Lipoprotein (HDL) Change
Description
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.
Time Frame
Change from baseline HDL at 10 weeks
Title
C-Reactive Protein (CRP) Change
Description
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.
Time Frame
Change from baseline C-reactive protein at 10 weeks
Title
Low Density Lipoprotein (LDL) Change
Description
This variable will be estimated by Friedewald equation.
Time Frame
Change from baseline LDL at 10 weeks
Title
Total Cholesterol/High Density Lipoprotein Ratio (TC/HDL ratio) Change
Description
This variable will be estimated by the simple division of variables.
Time Frame
Change from baseline TC/HDL at 10 weeks
Title
Peak Oxygen Consumption (VO2peak) Change
Description
This outcome will be measure through maximal progressive treadmill test, using the portable gas analyser VO2000 equipment.
Time Frame
Change from baseline VO2peak at 10 weeks
Title
Oxygen Consumption at anaerobic threshold (VO2VT2) Change
Description
This outcome will be measure through maximal progressive treadmill test, using the portable gas analyser VO2000 equipment.
Time Frame
Change from baseline VO2VT2 at 10 weeks
Title
Heart Rate at anaerobic threshold (HRVT2) Change
Description
This outcome will be measure through maximal progressive treadmill test, using a heart rate monitor (POLAR, FT1).
Time Frame
Change from baseline HRVT2 at 10 weeks
Title
Rest Heart Rate (HRrest) Change
Description
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.
Time Frame
Change from baseline HRrest at 10 weeks
Title
Lipoprotein Lipase (LPL) Change
Description
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).
Time Frame
Change from baseline LPL at 10 weeks
Title
Maximal dynamic muscle strength of knees extensors (MSKE) Change
Description
This outcome will be measured through the one-repetition maximal test (1RM).
Time Frame
Change from baseline MSKE at 10 weeks
Title
Maximal dynamic muscle strength of knees flexors (MSKF) Change
Description
This outcome will be measured through the one-repetition maximal test (1RM).
Time Frame
Change from baseline MSKF at 10 weeks
Title
Maximal dynamic muscle strength of horizontal shoulder flexors (MSHSF) Change
Description
This outcome will be measured through the one-repetition maximal test (1RM).
Time Frame
Change from baseline MSHSF at 10 weeks
Title
Rest Cardiac Output (COrest) Change
Description
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.
Time Frame
Change from baseline COrest at 10 weeks
Title
Rest Stroke Volume (SVrest) Change
Description
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.
Time Frame
Change from baseline SVrest at 10 weeks
Title
Peak Cardiac Output (COpeak) Change
Description
This outcome will be measured through Impedance Cardiography (Physioflow Lab-1 equipment), during a maximal progressive treadmill test.
Time Frame
Change from baseline COpeak at 10 weeks
Title
Peak Stroke Volume (SVpeak) Change
Description
This outcome will be measured through Impedance Cardiography (Physioflow Lab-1 equipment), during a maximal progressive treadmill test.
Time Frame
Change from baseline SVpeak at 10 weeks
Title
Rest Arterial Systolic Blood Pressure (SBPrest) Change
Description
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.
Time Frame
Change from baseline SBPrest at 10 weeks
Title
Rest Arterial Diastolic Blood Pressure (DBPrest) Change
Description
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.
Time Frame
Change from baseline DBPrest at 10 weeks
Title
Cardiovascular Risk Score (CRS) Change
Description
The Reynolds Risk Score Instrument will be used to estimate the cardiovascular risk.
Time Frame
Change from baseline cardiovascular risk score at 10 weeks
Title
Quality of Life Change
Description
The quality of life will be estimated using the Whoqol-Bref instrument.
Time Frame
Change from baseline quality of life at 10 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Stein
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Two Aquatic Training Models in Physiological Parameters of Elderly Dyslipidemic Women.
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