NCT02900612

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

3 months

First QC Date

September 6, 2016

Last Update Submit

September 9, 2016

Conditions

Keywords

dyslipidemias,agingwater aerobics trainingresistance aquatic traininglipid profile

Outcome Measures

Primary Outcomes (1)

  • Total Cholesterol (TC) Change

    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

Secondary Outcomes (21)

  • Triglycerides (TG) Change

    Change from baseline triglycerides at 10 weeks

  • High Density Lipoprotein (HDL) Change

    Change from baseline HDL at 10 weeks

  • C-Reactive Protein (CRP) Change

    Change from baseline C-reactive protein at 10 weeks

  • Low Density Lipoprotein (LDL) Change

    Change from baseline LDL at 10 weeks

  • Total Cholesterol/High Density Lipoprotein Ratio (TC/HDL ratio) Change

    Change from baseline TC/HDL at 10 weeks

  • +16 more secondary outcomes

Study Arms (3)

WA (Water Aerobics Training)

EXPERIMENTAL

Water aerobics training.

Other: Water aerobics training.

WR (Water Resistance Training)

EXPERIMENTAL

Resistance aquatic training.

Other: Water resistance training.

CG (Control Group)

ACTIVE COMPARATOR

Control Group.

Other: Control Group

Interventions

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.

Also known as: WA
WA (Water Aerobics 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.

Also known as: WR
WR (Water Resistance Training)

The control group will perform relaxation classes, including meditation, balance exercises, coordination exercises.

Also known as: CG
CG (Control Group)

Eligibility Criteria

Age60 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dyslipidemias

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ricardo Stein

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 14, 2016

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

September 14, 2016

Record last verified: 2016-09