Effects of Two Aquatic Training Models in Physiological Parameters of Elderly Dyslipidemic Women.
9 de septiembre de 2016 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
45
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
60 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
Otros nombres:
|
|
Experimental: 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.
Otros nombres:
|
|
Comparador activo: CG (Control Group)
Control Group.
|
The control group will perform relaxation classes, including meditation, balance exercises, coordination exercises.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total Cholesterol (TC) Change
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Triglycerides (TG) Change
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Ricardo Stein, Hospital de Clinicas de Porto Alegre
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2015
Finalización primaria (Actual)
1 de marzo de 2016
Finalización del estudio (Actual)
1 de mayo de 2016
Fechas de registro del estudio
Enviado por primera vez
6 de septiembre de 2016
Primero enviado que cumplió con los criterios de control de calidad
9 de septiembre de 2016
Publicado por primera vez (Estimar)
14 de septiembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
14 de septiembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2016
Última verificación
1 de septiembre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 14-0547
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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