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
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring water-base exercise
Eligibility Criteria
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
NCT ID
NCT03210597
First Posted
June 22, 2017
Last Updated
October 10, 2018
Sponsor
Federal University of Rio Grande do Sul
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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