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

9 september 2016 bijgewerkt door: Hospital de Clinicas de Porto Alegre

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

45

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

60 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: WA (Water Aerobics Training)
Water aerobics training.
Ander: 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.
Andere namen:
  • WA
Experimenteel: WR (Water Resistance Training)
Resistance aquatic training.
Ander: 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.
Andere namen:
  • WR
Actieve vergelijker: CG (Control Group)
Control Group.
Ander: Control Group
The control group will perform relaxation classes, including meditation, balance exercises, coordination exercises.
Andere namen:
  • CG

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Total Cholesterol (TC) Change
Tijdsspanne: 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.
Change from baseline total cholesterol at 10 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Triglycerides (TG) Change
Tijdsspanne: Change from baseline triglycerides 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.
Change from baseline triglycerides at 10 weeks
High Density Lipoprotein (HDL) Change
Tijdsspanne: Change from baseline HDL 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.
Change from baseline HDL at 10 weeks
C-Reactive Protein (CRP) Change
Tijdsspanne: Change from baseline C-reactive protein at 10 weeks
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
Tijdsspanne: Change from baseline LDL at 10 weeks
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
Tijdsspanne: Change from baseline TC/HDL at 10 weeks
This variable will be estimated by the simple division of variables.
Change from baseline TC/HDL at 10 weeks
Peak Oxygen Consumption (VO2peak) Change
Tijdsspanne: Change from baseline VO2peak at 10 weeks
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
Tijdsspanne: Change from baseline VO2VT2 at 10 weeks
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
Tijdsspanne: Change from baseline HRVT2 at 10 weeks
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
Tijdsspanne: Change from baseline HRrest at 10 weeks
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
Tijdsspanne: Change from baseline LPL at 10 weeks
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
Tijdsspanne: Change from baseline MSKE at 10 weeks
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
Tijdsspanne: Change from baseline MSKF at 10 weeks
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
Tijdsspanne: Change from baseline MSHSF at 10 weeks
This outcome will be measured through the one-repetition maximal test (1RM).
Change from baseline MSHSF at 10 weeks
Rest Cardiac Output (COrest) Change
Tijdsspanne: Change from baseline COrest at 10 weeks
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
Tijdsspanne: Change from baseline SVrest at 10 weeks
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
Tijdsspanne: Change from baseline COpeak at 10 weeks
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
Tijdsspanne: Change from baseline SVpeak at 10 weeks
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
Tijdsspanne: Change from baseline SBPrest at 10 weeks
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
Tijdsspanne: Change from baseline DBPrest at 10 weeks
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
Tijdsspanne: Change from baseline cardiovascular risk score at 10 weeks
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
Tijdsspanne: Change from baseline quality of life at 10 weeks
The quality of life will be estimated using the Whoqol-Bref instrument.
Change from baseline quality of life at 10 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospital de Clinicas de Porto Alegre

Onderzoekers

  • Hoofdonderzoeker: Ricardo Stein, Hospital de Clinicas de Porto Alegre

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2015

Primaire voltooiing (Werkelijk)

1 maart 2016

Studie voltooiing (Werkelijk)

1 mei 2016

Studieregistratiedata

Eerst ingediend

6 september 2016

Eerst ingediend dat voldeed aan de QC-criteria

9 september 2016

Eerst geplaatst (Schatting)

14 september 2016

Updates van studierecords

Laatste update geplaatst (Schatting)

14 september 2016

Laatste update ingediend die voldeed aan QC-criteria

9 september 2016

Laatst geverifieerd

1 september 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 14-0547

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

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