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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
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

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

60 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    September 6, 2016
    Last Updated
    September 9, 2016
    Sponsor
    Hospital de Clinicas de Porto Alegre
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    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

    Learn more about this trial

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

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