Metabolic SyndromeNCT03210597
Effects of Water-Based Exercise in Women With Metabolic Syndrome
A study testing Exercise in people with Metabolic Syndrome, run by Federal University of Rio Grande do Sul.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 10 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal;
- Sedentary;
- Presented at least three positive components within the five possible to characterize the metabolic syndrome.
Who cannot join
- Smokers.
About this study
Official title: Effects of Water-Based Aerobic Training, Resistance Training and Concurrent Training in Women With Metabolic Syndrome: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Exercise
- Keywords
- water-base exercise
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The subjects performed training in aquatic environment
| Study group | Role | What they receive |
|---|---|---|
| hydro-aerobic | Experimental | Water aerobics exercise Receives: Other: Exercise |
| hydro-power | Experimental | Resistance water exercise Receives: Other: Exercise |
| hydro-combined | Experimental | Water aerobics and resistance water exercise Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic blood pressure
mmHg
Measured: 12 weeks
Secondary outcomes (8)
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
Measured: 12 weeks
EMG test
Maximum isometric amplitude of the electromyographic signal of the vastus lateralis and rectus femoris muscles
Measured: 12 weeks
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
Measured: 12 weeks
Sit and Stand test
How often in 30 seconds the subject is able to get up and sit on a chair.
Measured: 12 weeks
Triglyceride levels
blood test: mg/dl
Measured: 12 weeks
HDL cholesterol levels
blood test: mg/dl
Measured: 12 weeks
Fasting blood glucose levels
blood test: mg/dl
Measured: 12 weeks
Waist circumference
centimeters
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start1 Aug 2016
- Primary completion28 Dec 2016
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Fernando Martins Kruel, Federal University of Rio Grande do Sul
- Investigators
- Luiz F. Martins Kruel, Study director, Federal Universty of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210597
- Sponsor's protocol ID
- CEP UFRGS 1.499.603
- Status last verified
- Oct 2018
- First submitted
- 22 Jun 2017
- Last updated
- 12 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Water-Based Aerobic Training, Resistance Training and Concurrent Training in Women With Metabolic Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03210597
- Acronym / sponsor ID
- CEP UFRGS 1.499.603
- Conditions
- Metabolic Syndrome
- Keywords
- water-base exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 28 Dec 2016 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hydro-aerobic | Experimental | Other: ExerciseWater aerobics exercise |
| hydro-power | Experimental | Other: ExerciseResistance water exercise |
| hydro-combined | Experimental | Other: ExerciseWater aerobics and resistance water exercise |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal;
- Sedentary;
- Presented at least three positive components within the five possible to characterize the metabolic syndrome.
Key exclusion criteria (1 listed)
- Smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe subjects performed training in aquatic environment | Other | hydro-aerobic, hydro-combined, hydro-power |
Primary outcome
Systolic and diastolic blood pressure
Time frame: 12 weeks
mmHg
8 secondary outcomes
Strength tests: Maximum dynamic muscle strength
Time frame: 12 weeks
EMG test
Time frame: 12 weeks
Time Up and go test
Time frame: 12 weeks
Sit and Stand test
Time frame: 12 weeks
Triglyceride levels
Time frame: 12 weeks
HDL cholesterol levels
Time frame: 12 weeks
Fasting blood glucose levels
Time frame: 12 weeks
Waist circumference
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiz F. Martins Kruel study director
Federal Universty of Rio Grande do Sul
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Metabolic Syndrome, run by Federal University of Rio Grande do Sul.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and diastolic blood pressure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.