DyslipidemiasNCT02900612
Effects of Two Aquatic Training Models in Physiological Parameters of Elderly Dyslipidemic Women.
A study testing Water aerobics training. and Water resistance training. in people with Dyslipidemias, run by Hospital de Clinicas de Porto Alegre.
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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Water aerobics training. and Water resistance training.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effects of Two Aquatic Training Models in Physiological Parameters of Elderly Dyslipidemic Women: a Randomized Controlled Clinical Trial.
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.
Read the 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.
- Conditions
- Dyslipidemias
- Being tested
- Water aerobics training., Water resistance training., Control Group
- Keywords
- dyslipidemias,, aging, water aerobics training, resistance aquatic training, lipid profile
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water aerobics training.Other
Also called WA
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.Other
Also called WR
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 GroupOther
Also called CG
The control group will perform relaxation classes, including meditation, balance exercises, coordination exercises.
| Study group | Role | What they receive |
|---|---|---|
| WA (Water Aerobics Training) | Experimental | Water aerobics training. Receives: Other: Water aerobics training. |
| WR (Water Resistance Training) | Experimental | Resistance aquatic training. Receives: Other: Water resistance training. |
| CG (Control Group) | Active comparator | Control Group. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline total cholesterol at 10 weeks
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline C-reactive protein at 10 weeks
Low Density Lipoprotein (LDL) Change
This variable will be estimated by Friedewald equation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline quality of life at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Stein, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900612
- Sponsor's protocol ID
- 14-0547
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Aquatic Training Models in Physiological Parameters of Elderly Dyslipidemic Women: a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT02900612
- Acronym / sponsor ID
- 14-0547
- Conditions
- Dyslipidemias
- Keywords
- dyslipidemias,, aging, water aerobics training, resistance aquatic training, lipid profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WA (Water Aerobics Training) | Experimental | Other: Water aerobics training.Water aerobics training. |
| WR (Water Resistance Training) | Experimental | Other: Water resistance training.Resistance aquatic training. |
| CG (Control Group) | Active comparator | Other: Control GroupControl Group. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water aerobics training.Also: WAThe 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. | Other | WA (Water Aerobics Training) |
| Water resistance training.Also: WRThe WR group will perform four to eight sets of 20 to 10 seconds along the macrocycle, always at maximal speed execution of the exercises. | Other | WR (Water Resistance Training) |
| Control GroupAlso: CGThe control group will perform relaxation classes, including meditation, balance exercises, coordination exercises. | Other | CG (Control Group) |
Primary outcome
Total Cholesterol (TC) Change
Time frame: Change from baseline total cholesterol at 10 weeks
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.
21 secondary outcomes
Triglycerides (TG) Change
Time frame: Change from baseline triglycerides at 10 weeks
High Density Lipoprotein (HDL) Change
Time frame: Change from baseline HDL at 10 weeks
C-Reactive Protein (CRP) Change
Time frame: Change from baseline C-reactive protein at 10 weeks
Low Density Lipoprotein (LDL) Change
Time frame: Change from baseline LDL at 10 weeks
Total Cholesterol/High Density Lipoprotein Ratio (TC/HDL ratio) Change
Time frame: Change from baseline TC/HDL at 10 weeks
Peak Oxygen Consumption (VO2peak) Change
Time frame: Change from baseline VO2peak at 10 weeks
Oxygen Consumption at anaerobic threshold (VO2VT2) Change
Time frame: Change from baseline VO2VT2 at 10 weeks
Heart Rate at anaerobic threshold (HRVT2) Change
Time frame: Change from baseline HRVT2 at 10 weeks
Rest Heart Rate (HRrest) Change
Time frame: Change from baseline HRrest at 10 weeks
Lipoprotein Lipase (LPL) Change
Time frame: Change from baseline LPL at 10 weeks
Maximal dynamic muscle strength of knees extensors (MSKE) Change
Time frame: Change from baseline MSKE at 10 weeks
Maximal dynamic muscle strength of knees flexors (MSKF) Change
Time frame: Change from baseline MSKF at 10 weeks
Maximal dynamic muscle strength of horizontal shoulder flexors (MSHSF) Change
Time frame: Change from baseline MSHSF at 10 weeks
Rest Cardiac Output (COrest) Change
Time frame: Change from baseline COrest at 10 weeks
Rest Stroke Volume (SVrest) Change
Time frame: Change from baseline SVrest at 10 weeks
Peak Cardiac Output (COpeak) Change
Time frame: Change from baseline COpeak at 10 weeks
Peak Stroke Volume (SVpeak) Change
Time frame: Change from baseline SVpeak at 10 weeks
Rest Arterial Systolic Blood Pressure (SBPrest) Change
Time frame: Change from baseline SBPrest at 10 weeks
Rest Arterial Diastolic Blood Pressure (DBPrest) Change
Time frame: Change from baseline DBPrest at 10 weeks
Cardiovascular Risk Score (CRS) Change
Time frame: Change from baseline cardiovascular risk score at 10 weeks
Quality of Life Change
Time frame: Change from baseline quality of life at 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Stein principal investigator
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Water aerobics training. and Water resistance training. in people with Dyslipidemias, run by Hospital de Clinicas de Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cholesterol (TC) Change (time frame: Change from baseline total cholesterol at 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.