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Effects of Water-Based Exercise in Women With Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring water-base exercise

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Postmenopausal;
  • Sedentary;
  • Presented at least three positive components within the five possible to characterize the metabolic syndrome.

Exclusion Criteria:

  • Smokers.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    hydro-aerobic

    hydro-power

    hydro-combined

    Arm Description

    Water aerobics exercise

    Resistance water exercise

    Water aerobics and resistance water exercise

    Outcomes

    Primary Outcome Measures

    Systolic and diastolic blood pressure
    mmHg

    Secondary Outcome Measures

    Strength tests: Maximum dynamic muscle strength
    One repetition test: how many kilograms the subject is able to withstand on a repetition of elbow flexion and knee extension exercise
    EMG test
    Maximum isometric amplitude of the electromyographic signal of the vastus lateralis and rectus femoris muscles
    Time Up and go test
    How long (in seconds) the subject needs to lift from a chair, walk 2.44 meters, and sit in a chair again
    Sit and Stand test
    How often in 30 seconds the subject is able to get up and sit on a chair.
    Triglyceride levels
    blood test: mg/dl
    HDL cholesterol levels
    blood test: mg/dl
    Fasting blood glucose levels
    blood test: mg/dl
    Waist circumference
    centimeters

    Full Information

    First Posted
    June 22, 2017
    Last Updated
    October 10, 2018
    Sponsor
    Federal University of Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03210597
    Brief Title
    Effects of Water-Based Exercise in Women With Metabolic Syndrome
    Official Title
    Effects of Water-Based Aerobic Training, Resistance Training and Concurrent Training in Women With Metabolic Syndrome: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    December 28, 2016 (Actual)
    Study Completion Date
    October 10, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Rio Grande do Sul

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The objective of the present study was to compare the neuromuscular, cardiorespiratory and metabolic effects of 12 weeks of aerobic training, strength training and combined training in the aquatic environment in women with MS. For this purpose, 51 postmenopausal, sedentary and MS women were randomly divided into three intervention groups: hydro-aerobic (HA, n = 18, 63.77 ± 5.03 years), hydro-power (HF, n = 16, 61.01 ± 4.93 years) and hydro-combined (HC; n = 17; 60.52 ± 6.91). A subsample participated in eight weeks without physical exercise to characterize a control period. The three intervention groups performed two weekly sessions of 60 minutes for 12 weeks. Before and after the training period, blood tests, muscle strength tests, cardiorespiratory evaluation, functional tests and a questionnaire were performed. For statistical analysis, the Generalized Estimates Equations (GEE) model was used, using the "group" and the "time" as factors. The Bonferroni post hoc was used to locate the differences and the significance index adopted was α = 0.05.
    Detailed Description
    Water-based exercise as a mode of aquatic exercise has been highlighted in the scientific literature. Research on different models of training, aerobic, muscle strength and combined (aerobic and muscle strength), have already demonstrated their beneficial effects on different physical abilities. Recent studies indicate benefits of water-based exercise for the population with metabolic diseases such as hypertension, type 2 diabetes, dyslipidemias and obesity. However, for subjects with metabolic syndrome (MS) there are few studies that investigated which training model in the aquatic environment could generate physical and metabolic improvements. This study is characterized as a randomized clinical trial, which treated three intervention groups with physical exercise programs. A subsample participated in a period of eight weeks without physical exercise to characterize a control period. The subjects in this subsample were later randomized into the intervention groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome
    Keywords
    water-base exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Participant: During the training period the subjects were not informed about the training modality they were performing and also were not informed about the modalities of the other subjects, only they were informed that hydrogymnastic sessions would be performed. Outcomes assessor:The team evaluating the outcomes was blinded, not receiving information about the intervention received by the subjects participating in the study
    Allocation
    Randomized
    Enrollment
    51 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    hydro-aerobic
    Arm Type
    Experimental
    Arm Description
    Water aerobics exercise
    Arm Title
    hydro-power
    Arm Type
    Experimental
    Arm Description
    Resistance water exercise
    Arm Title
    hydro-combined
    Arm Type
    Experimental
    Arm Description
    Water aerobics and resistance water exercise
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    The subjects performed training in aquatic environment
    Primary Outcome Measure Information:
    Title
    Systolic and diastolic blood pressure
    Description
    mmHg
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Strength tests: Maximum dynamic muscle strength
    Description
    One repetition test: how many kilograms the subject is able to withstand on a repetition of elbow flexion and knee extension exercise
    Time Frame
    12 weeks
    Title
    EMG test
    Description
    Maximum isometric amplitude of the electromyographic signal of the vastus lateralis and rectus femoris muscles
    Time Frame
    12 weeks
    Title
    Time Up and go test
    Description
    How long (in seconds) the subject needs to lift from a chair, walk 2.44 meters, and sit in a chair again
    Time Frame
    12 weeks
    Title
    Sit and Stand test
    Description
    How often in 30 seconds the subject is able to get up and sit on a chair.
    Time Frame
    12 weeks
    Title
    Triglyceride levels
    Description
    blood test: mg/dl
    Time Frame
    12 weeks
    Title
    HDL cholesterol levels
    Description
    blood test: mg/dl
    Time Frame
    12 weeks
    Title
    Fasting blood glucose levels
    Description
    blood test: mg/dl
    Time Frame
    12 weeks
    Title
    Waist circumference
    Description
    centimeters
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Postmenopausal; Sedentary; Presented at least three positive components within the five possible to characterize the metabolic syndrome. Exclusion Criteria: Smokers.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luiz F. Martins Kruel
    Organizational Affiliation
    Federal Universty of Rio Grande do Sul
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of Water-Based Exercise in Women With Metabolic Syndrome

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