ObesityNCT04802005
Effects of a Short-term Aerobic Interval Exercise Program on Cardiac Fat and Function in Women With Obesity: A Pilot Study
A study testing Aerobic Interval Training in people with Obesity, run by Southern Illinois University Edwardsville at 1 site in United States.
Trial summary
The overall goal of this project is to the study the effects of an aerobic interval training program on cardiac fat, and its relationship to cardiac function using cardiac Magnetic Resonance Imaging. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Aerobic Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 16 Apr 2021
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- females, age 18-40 years old, body mass index (BMI) ≥ 30 kg/m2 and < 39.9 kg/m2, without known metabolic and/or cardiovascular disease
Who cannot join
- known CV, metabolic or pulmonary diseases or conditions, muscular-skeletal injuries (i.e. spine, knees, hips or shoulders, taking medications that affect endocrine or cardiovascular function, hypertension, being engaged in moderate intensity exercise more than two times per week or moderate-high intensity training of any type and frequency, being pregnant, cigarette smoking, having non-removable pieces or devices incompatible with DXA and CMR assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Illinois University Edwardsville
Edwardsville, Illinois, 62026
About this study
The overall goal of this project is to the study the effects of an aerobic interval training program on cardiac fat, and its relationship to cardiac function using cardiac Magnetic Resonance Imaging.
- Conditions
- Obesity
- Being tested
- Aerobic Interval Training
- Keywords
- Cardiac fat, Cardiac function, Aerobic interval training, Cardiac Magnetic Resonance, Vascular health
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Interval TrainingOther
The aerobic interval training group
| Study group | Role | What they receive |
|---|---|---|
| Aerobic interval | Experimental | Aerobic interval will consist of a supervised aerobic interval training sessions 3 times/week. Duration will range between 45-50 min/session depending on the exercise energy expenditure (target expenditure ~450-500kcal/session). Each interval will have a total duration of 5 min, and it will be divided into 2 periods. The first period will consist of 3 minutes of high-intensity activity at 70-85% of predicted HRmax, and for the second period the intensity will be reduced to 60-65% of predicted HRmax for 2 minutes. The training sessions will be carried out outdoors at the trails located on campus. The activity will consist of walking and/or light jogging. The speed/incline will be changed depending on the participants' heart rate and perception using the Borg's rating of perceived exertion (RPE) as needed. The RPE for the first period range will be 13-17 (15-17 at the end of the period) and 10-12 for the second period. Receives: Other: Aerobic Interval Training |
| Control group | No intervention | Participants in the control group will not participate in the training programs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cardiac Adipose Tissue (CAT)
CAT will be measured using cardiac Magnetic Resonance
Measured: 2 assessment points: at baseline and week 5
Changes in Cardiac Function
Cardiac Function will be measured using cardiac Magnetic Resonance
Measured: 2 assessment points: at baseline and week 5
Secondary outcomes (4)
Changes in Body Composition
Body composition will be measured using dual-energy x-ray absorptiometry
Measured: 2 assessment points: at baseline and week 5
Changes in Cardiorespiratory Function
Cardiorespiratory Function will be measured on a treadmill with a metabolic cart
Measured: 2 assessment points: at baseline and week 5
Changes in Muscular Strength
Muscular Strength will be assessed through 1 repetition maximum (1RM).
Measured: 2 assessment points: at baseline and week 5
Changes in Blood Pressure
Blood pressure will be measured using pulse wave analysis
Measured: 2 assessment points: at baseline and week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start16 Mar 2021
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
Why it stopped: PI moved to another institution
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University Edwardsville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Fernandez Del Valle, Southern Illinois University Edwardsville
- Investigators
- Maria Fernandez Del Valle, PhD, Principal investigator, Southern Illinois University of Edwardsville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802005
- Sponsor's protocol ID
- 1063
- Status last verified
- Sep 2021
- First submitted
- 13 Mar 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Short-term Aerobic Interval Exercise Program on Cardiac Fat and Function in Women With Obesity: A Pilot Study
- ClinicalTrials.gov ID
- NCT04802005
- Acronym / sponsor ID
- 1063
- Conditions
- Obesity
- Keywords
- Cardiac fat, Cardiac function, Aerobic interval training, Cardiac Magnetic Resonance, Vascular health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI moved to another institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Southern Illinois University EdwardsvilleUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 17 Mar 2021 (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 overall goal of this project is to the study the effects of an aerobic interval training program on cardiac fat, and its relationship to cardiac function using cardiac Magnetic Resonance Imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic interval | Experimental | Other: Aerobic Interval TrainingAerobic interval will consist of a supervised aerobic interval training sessions 3 times/week. Duration will range between 45-50 min/session depending on the exercise energy expenditure (target expenditure ~450-500kcal/session). Each interval will have a total duration of 5 min, and it will be divided into 2 periods. The first period will consist of 3 minutes of high-intensity activity at 70-85% of predicted HRmax, and for the second period the intensity will be reduced to 60-65% of predicted HRmax for 2 minutes. The training sessions will be carried out outdoors at the trails located on campus. The activity will consist of walking and/or light jogging. The speed/incline will be changed depending on the participants' heart rate and perception using the Borg's rating of perceived exertion (RPE) as needed. The RPE for the first period range will be 13-17 (15-17 at the end of the period) and 10-12 for the second period. |
| Control group | No intervention | –Participants in the control group will not participate in the training programs. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- females, age 18-40 years old, body mass index (BMI) ≥ 30 kg/m2 and < 39.9 kg/m2, without known metabolic and/or cardiovascular disease
Key exclusion criteria (1 listed)
- known CV, metabolic or pulmonary diseases or conditions, muscular-skeletal injuries (i.e. spine, knees, hips or shoulders, taking medications that affect endocrine or cardiovascular function, hypertension, being engaged in moderate intensity exercise more than two times per week or moderate-high intensity training of any type and frequency, being pregnant, cigarette smoking, having non-removable pieces or devices incompatible with DXA and CMR assessment
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 |
|---|---|---|
| Aerobic Interval TrainingThe aerobic interval training group | Other | Aerobic interval |
Primary outcome
Changes in Cardiac Adipose Tissue (CAT)
Time frame: 2 assessment points: at baseline and week 5
CAT will be measured using cardiac Magnetic Resonance
Changes in Cardiac Function
Time frame: 2 assessment points: at baseline and week 5
Cardiac Function will be measured using cardiac Magnetic Resonance
4 secondary outcomes
Changes in Body Composition
Time frame: 2 assessment points: at baseline and week 5
Changes in Cardiorespiratory Function
Time frame: 2 assessment points: at baseline and week 5
Changes in Muscular Strength
Time frame: 2 assessment points: at baseline and week 5
Changes in Blood Pressure
Time frame: 2 assessment points: at baseline and week 5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- 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.
Maria Fernandez Del Valle, PhD principal investigator
Southern Illinois University of Edwardsville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Interval Training in people with Obesity, run by Southern Illinois University Edwardsville 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 1 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: withdrawn, as of the sponsor's last update on 21 Sep 2021. 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 was withdrawn before enrolling participants, so there are no results.
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 Adipose Tissue (CAT) (time frame: 2 assessment points: at baseline and week 5). The study lists 2 primary outcomes in all. 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 21 Sep 2021.