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

9 septembre 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

45

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

60 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: WA (Water Aerobics Training)
Water aerobics training.
Autre: 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.
Autres noms:
  • WA
Expérimental: WR (Water Resistance Training)
Resistance aquatic training.
Autre: 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.
Autres noms:
  • WR
Comparateur actif: CG (Control Group)
Control Group.
Autre: Control Group
The control group will perform relaxation classes, including meditation, balance exercises, coordination exercises.
Autres noms:
  • CG

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Total Cholesterol (TC) Change
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Triglycerides (TG) Change
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospital de Clinicas de Porto Alegre

Les enquêteurs

  • Chercheur principal: Ricardo Stein, Hospital de Clínicas de Porto Alegre

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2015

Achèvement primaire (Réel)

1 mars 2016

Achèvement de l'étude (Réel)

1 mai 2016

Dates d'inscription aux études

Première soumission

6 septembre 2016

Première soumission répondant aux critères de contrôle qualité

9 septembre 2016

Première publication (Estimation)

14 septembre 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

14 septembre 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 septembre 2016

Dernière vérification

1 septembre 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 14-0547

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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