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

9. september 2016 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

45

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: WA (Water Aerobics Training)
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.
Andre navne:
  • WA
Eksperimentel: WR (Water Resistance Training)
Resistance aquatic 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.
Andre navne:
  • WR
Aktiv komparator: CG (Control Group)
Control Group.
The control group will perform relaxation classes, including meditation, balance exercises, coordination exercises.
Andre navne:
  • CG

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Cholesterol (TC) Change
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Triglycerides (TG) Change
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Ricardo Stein, Hospital de Clínicas de Porto Alegre

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2015

Primær færdiggørelse (Faktiske)

1. marts 2016

Studieafslutning (Faktiske)

1. maj 2016

Datoer for studieregistrering

Først indsendt

6. september 2016

Først indsendt, der opfyldte QC-kriterier

9. september 2016

Først opslået (Skøn)

14. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. september 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2016

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

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