Effects of Two Aquatic Training Models in Physiological Parameters of Elderly Dyslipidemic Women.
9. září 2016 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
45
Fáze
- Nelze použít
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
60 let až 75 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
|
|
Experimentální: 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.
Ostatní jména:
|
|
Aktivní komparátor: CG (Control Group)
Control Group.
|
The control group will perform relaxation classes, including meditation, balance exercises, coordination exercises.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Total Cholesterol (TC) Change
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Triglycerides (TG) Change
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Ricardo Stein, Hospital de Clínicas de Porto Alegre
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. prosince 2015
Primární dokončení (Aktuální)
1. března 2016
Dokončení studie (Aktuální)
1. května 2016
Termíny zápisu do studia
První předloženo
6. září 2016
První předloženo, které splnilo kritéria kontroly kvality
9. září 2016
První zveřejněno (Odhad)
14. září 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
14. září 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. září 2016
Naposledy ověřeno
1. září 2016
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 14-0547
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NEROZHODNÝ
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