ObesityNCT01692314
Effect of Resistance Training on Microvascular, Hemodynamic and Physical Parameters in Obese Adolescents
A study testing Resistance training in people with Obesity, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
The purpose of this study is to investigate the effect os resistance training on microvascular reactivity, endothelial functions, inflammatory markers, blood pressure, heart rate, body composition and physical fitness in obese adolescents. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2010to May 2012
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Tanner pubertal stage of development between three and five
- age between 13 up to 17 years old
Who cannot join
- presence of chronic diseases (diabetes mellitus, nephropathy and/or hypertension),
- musculoskeletal injury,
- smoking and
- to be in use of any medication.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory for Clinical and Experimental Research in Vascular Biology (BioVasc), Biomedical Center, State University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro
About this study
Official title: Effect of Resistance Training on Microvascular Reactivity, Endothelial Function, Inflammatory Markers, Body Composition, Blood Pressure, Heart Rate and Physical Fitness in Obese Adolescents
The purpose of this study is to investigate the effect os resistance training on microvascular reactivity, endothelial functions, inflammatory markers, blood pressure, heart rate, body composition and physical fitness in obese adolescents.
- Conditions
- Obesity
- Being tested
- Resistance training
- Keywords
- Endothelial function, Microvascular reactivity, Obesity, Adolescents
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Obese adolescents is being compared to control ones | Experimental | Patients underwent to resistance training, three times a week, during three months. Receives: Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular Reactivity
Measured: Three months
Secondary outcomes (1)
Endothelial function
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Ingrid Barbara Ferreira Dias, Rio de Janeiro State University
- Investigators
- Eliete Bouskela, Phd, Study director, State University of Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692314
- Sponsor's protocol ID
- BIOVASC 2009
- Status last verified
- Sep 2012
- First submitted
- 14 Sep 2012
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistance Training on Microvascular Reactivity, Endothelial Function, Inflammatory Markers, Body Composition, Blood Pressure, Heart Rate and Physical Fitness in Obese Adolescents
- ClinicalTrials.gov ID
- NCT01692314
- Acronym / sponsor ID
- BIOVASC 2009
- Conditions
- Obesity
- Keywords
- Endothelial function, Microvascular reactivity, Obesity, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Sep 2012 (estimated)
- 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 purpose of this study is to investigate the effect os resistance training on microvascular reactivity, endothelial functions, inflammatory markers, blood pressure, heart rate, body composition and physical fitness in obese adolescents.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese adolescents is being compared to control ones | Experimental | Other: Resistance trainingPatients underwent to resistance training, three times a week, during three months. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Tanner pubertal stage of development between three and five
- age between 13 up to 17 years old
Key exclusion criteria (4 listed)
- presence of chronic diseases (diabetes mellitus, nephropathy and/or hypertension),
- musculoskeletal injury,
- smoking and
- to be in use of any medication.
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 |
|---|---|---|
| Resistance training | Other | Obese adolescents is being compared to control ones |
Primary outcome
Microvascular Reactivity
Time frame: Three months
1 secondary outcome
Endothelial function
Time frame: Three months
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 25 Sep 2012.
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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.
Eliete Bouskela, Phd study director
State University of Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Obesity, run by Rio de Janeiro State University at 1 site in Brazil.
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 2 inclusion and 4 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 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Microvascular Reactivity (time frame: Three months). 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 25 Sep 2012.