ObesityNCT02589327
Effects of Exercise on Cardiac Fat in Women With Obesity: a Pilot Study
A study testing Exercise Intervention in people with Obesity, run by Texas Tech University at 1 site in United States.
Trial summary
Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac and metabolic risk. The aim of this study the effects of exercise in cardiac fat content, cardiac function, physical fitness, and metabolic activity in obesity. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to May 2016
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 30-39.99
- White/Caucasian
Who cannot join
- Known health problems such as cardiovascular, pulmonary or metabolic disease will be excluded.
- Pregnant females.
- Any adults found taking medications that affect endocrine or cardiovascular function will also be excluded from the study.
- Participants that exercise more than three times per week or strength train more than twice per week.
- Individuals that have poor venous access or have expressed a fear of needles or having blood taken will also be excluded.
- Cigarette smoking (current or those who quit within the previous 6 months
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- Hypertension
- Diabetics
- MRI exclusion criteria must be observed: must complete a safety checklist that is designed to identify metal in your body that could pose a hazard during scanning. Some forms of metal are acceptable (e.g., dental fillings after 1970). Tattoos are generally not exclusionary, unless they have been inked with metallic dyes. All metal must be removed from your body. All female subjects, prior to scanning, are required to complete a pregnancy test. Must NOT be claustrophobic or have a history of claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Kinesiology and Sport Management
Lubbock, Texas, 79423
About this study
Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac and metabolic risk. The aim of this study the effects of exercise in cardiac fat content, cardiac function, physical fitness, and metabolic activity in obesity.
Read the detailed description
Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac and metabolic risk. More effective treatments are needed to induce changes in cardiac fat content, body composition, and cardiac fat metabolic activity that result in a reduction in cardiovascular risk in overweight and obese population. Despite this need, little is known about which mode, frequency, and duration of exercise will allow for greater reductions in cardiac fat, improvements in body composition, restoration of a healthy cardiac fat metabolic activity, and improvement on cardiovascular risk markers. The aim of this study the effects of exercise in cardiac fat content, cardiac function, physical fitness, and metabolic activity in obesity.
- Conditions
- Obesity
- Being tested
- Exercise Intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention will consist of 3 weeks of whole body circuit training (resistance training) where participants in the intervention group will perform 7 different exercises. The circuit will consist of 10 repetitions per exercise of 7 exercises: leg press, bent-over row, bench press, squats, dumbbell jump squats with raises, dead-lifts and weighted abdominal crunches, with approximately 30 sec of rest in between each exercise (based on the estimated time needed to move from one position to the next). Each participant will move through the circuit 3 times, with 2 to 3 minutes of rest between each round. Intensity will be 6-7 of RPE at the first set, and 9-10 at the third set.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Hight intensity resistance training group Receives: Other: Exercise Intervention |
| Control | No intervention | No-exercise control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cardiac fat volumes
Cardiac fat volumes will be assessed by means of Magnetic Resonance Imaging
Measured: 2 assessment points: at baseline and week 4
Secondary outcomes (7)
Changes in Vascular function
Vascular function will be assessed by means of Arterial Tonometry
Measured: 2 assessment points: at baseline and week 4
Changes in Cardiorespiratory Function
Cardiorespiratory Function will be assessed on a treadmill test with a 12-lead EKG. Protocol: Modified Bruce (A baseline stage will be added)
Measured: 2 assessment points: at baseline and week 4
Changes in Muscular Strength
Muscular Strength in upper and lower extremities will be assessed by 1 repetition maximum (1RM) test on Bench Press and Leg Press
Measured: 2 assessment points: at baseline and week 4
Changes in Body Composition
Body Composition will be assessed using Dual-energy x-ray absorptiometry
Measured: 2 assessment points: at baseline and week 4
Changes in Diet
Diet will be assessed using the ASA24h recall (http://epi.grants.cancer.gov/asa24/)
Measured: 5 assessment points: baseline, week 1, 2, 3, and 4
Changes in Spontaneous Physical Activity
Spontaneous Physical Activity will be assessed using accelerometers Actical.
Measured: Baseline and week 4
Changes in Oxidative stress markers
Blood will be collected and processed in order to assess oxidative stress markers
Measured: 5 assessment points: pre-post during session 1, pre-post during session 9, and pre week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2016
- Study completionMay 2016
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Fernandez del Valle, PhD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589327
- Sponsor's protocol ID
- 504792C
- Status last verified
- Sep 2015
- First submitted
- 14 Oct 2015
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise on Cardiac Fat in Women With Obesity: a Pilot Study
- ClinicalTrials.gov ID
- NCT02589327
- Acronym / sponsor ID
- 504792C
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 28 Oct 2015 (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.
Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac and metabolic risk. The aim of this study the effects of exercise in cardiac fat content, cardiac function, physical fitness, and metabolic activity in obesity.
Detailed description
Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac and metabolic risk. More effective treatments are needed to induce changes in cardiac fat content, body composition, and cardiac fat metabolic activity that result in a reduction in cardiovascular risk in overweight and obese population. Despite this need, little is known about which mode, frequency, and duration of exercise will allow for greater reductions in cardiac fat, improvements in body composition, restoration of a healthy cardiac fat metabolic activity, and improvement on cardiovascular risk markers. The aim of this study the effects of exercise in cardiac fat content, cardiac function, physical fitness, and metabolic activity in obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Other: Exercise InterventionHight intensity resistance training group |
| Control | No intervention | –No-exercise control group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 30-39.99
- White/Caucasian
Key exclusion criteria (9 listed)
- Known health problems such as cardiovascular, pulmonary or metabolic disease will be excluded.
- Pregnant females.
- Any adults found taking medications that affect endocrine or cardiovascular function will also be excluded from the study.
- Participants that exercise more than three times per week or strength train more than twice per week.
- Individuals that have poor venous access or have expressed a fear of needles or having blood taken will also be excluded.
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 |
|---|---|---|
| Exercise InterventionThe intervention will consist of 3 weeks of whole body circuit training (resistance training) where participants in the intervention group will perform 7 different exercises. The circuit will consist of 10 repetitions per exercise of 7 exercises: leg press, bent-over row, bench press, squats, dumbbell jump squats with raises, dead-lifts and weighted abdominal crunches, with approximately 30 sec of rest in between each exercise (based on the estimated time needed to move from one position to the next). Each participant will move through the circuit 3 times, with 2 to 3 minutes of rest between each round. Intensity will be 6-7 of RPE at the first set, and 9-10 at the third set. | Other | Exercise Intervention |
Primary outcome
Changes in Cardiac fat volumes
Time frame: 2 assessment points: at baseline and week 4
Cardiac fat volumes will be assessed by means of Magnetic Resonance Imaging
7 secondary outcomes
Changes in Vascular function
Time frame: 2 assessment points: at baseline and week 4
Changes in Cardiorespiratory Function
Time frame: 2 assessment points: at baseline and week 4
Changes in Muscular Strength
Time frame: 2 assessment points: at baseline and week 4
Changes in Body Composition
Time frame: 2 assessment points: at baseline and week 4
Changes in Diet
Time frame: 5 assessment points: baseline, week 1, 2, 3, and 4
Changes in Spontaneous Physical Activity
Time frame: Baseline and week 4
Changes in Oxidative stress markers
Time frame: 5 assessment points: pre-post during session 1, pre-post during session 9, and pre week 4.
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 11 May 2016.
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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.
Maria Fernandez del Valle, PhD principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Obesity, run by Texas Tech University at 1 site in United States.
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 9 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 11 May 2016. 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 United States. 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?
Changes in Cardiac fat volumes (time frame: 2 assessment points: at baseline and week 4). 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 11 May 2016.