- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03210597
Effects of Water-Based Exercise in Women With Metabolic Syndrome
Effects of Water-Based Aerobic Training, Resistance Training and Concurrent Training in Women With Metabolic Syndrome: A Randomized Controlled Trial
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Postmenopausal;
- Sedentary;
- Presented at least three positive components within the five possible to characterize the metabolic syndrome.
Exclusion Criteria:
- Smokers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: hydro-aerobic
Water aerobics exercise
|
The subjects performed training in aquatic environment
|
|
EXPERIMENTAL: hydro-power
Resistance water exercise
|
The subjects performed training in aquatic environment
|
|
EXPERIMENTAL: hydro-combined
Water aerobics and resistance water exercise
|
The subjects performed training in aquatic environment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic and diastolic blood pressure
Time Frame: 12 weeks
|
mmHg
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength tests: Maximum dynamic muscle strength
Time Frame: 12 weeks
|
One repetition test: how many kilograms the subject is able to withstand on a repetition of elbow flexion and knee extension exercise
|
12 weeks
|
|
EMG test
Time Frame: 12 weeks
|
Maximum isometric amplitude of the electromyographic signal of the vastus lateralis and rectus femoris muscles
|
12 weeks
|
|
Time Up and go test
Time Frame: 12 weeks
|
How long (in seconds) the subject needs to lift from a chair, walk 2.44 meters, and sit in a chair again
|
12 weeks
|
|
Sit and Stand test
Time Frame: 12 weeks
|
How often in 30 seconds the subject is able to get up and sit on a chair.
|
12 weeks
|
|
Triglyceride levels
Time Frame: 12 weeks
|
blood test: mg/dl
|
12 weeks
|
|
HDL cholesterol levels
Time Frame: 12 weeks
|
blood test: mg/dl
|
12 weeks
|
|
Fasting blood glucose levels
Time Frame: 12 weeks
|
blood test: mg/dl
|
12 weeks
|
|
Waist circumference
Time Frame: 12 weeks
|
centimeters
|
12 weeks
|
Collaborators and Investigators
Investigators
- Study Director: Luiz F. Martins Kruel, Federal Universty of Rio Grande do Sul
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP UFRGS 1.499.603
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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