ObesityNCT03297333
Effects of Exercise Mode on Cardiac Fat and Function
A study testing Resistance training and 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 study the effects of exercise energy expenditure matched vigorous dynamic resistance training and aerobic training on cardiac fat, and its relationship to cardiac function and geometry using cardiac Magnetic Resonance Imaging. 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?
- Resistance training and Aerobic interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 16 Mar 2020
- 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
- Sedentary
- Caucasian
- BMI >30 kg/m2 and < 39.9 kg/m2
Who cannot join
- Known cardiovascular, metabolic, pulmonary disease or conditions
- Muscular-skeletal injuries
- Taking medications that affect endocrine or cardiovascular function
- Hypertension
- Being engaged in low intensity strength training more than two times per week or moderate-high intensity of any type of 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 of Edwardsville
Edwardsville, Illinois, 62026
About this study
The overall goal of this project is to study the effects of exercise energy expenditure matched vigorous dynamic resistance training and aerobic training on cardiac fat, and its relationship to cardiac function and geometry using cardiac Magnetic Resonance Imaging.
Read the detailed description
Exercise-induced weight-loss is one of the most common strategies for reducing excess fat in overweight and obese individuals. Although vigorous intensity may be more favorable promoting positive cardiac adaptations compared to low-moderate intensity, evidence of the positive effects of different exercise modes needs to be explored to allow for realistic comparisons with other strategies. Research using cardiac Magnetic Resonance Imaging that compares the effects of different modes of exercise - matched by exercise energy expenditure - on epicardial adipose tissue and paracardial adipose tissue, and how these interventions modify cardiac function and geometry have not been previously explored in obesity.
- Conditions
- Obesity
- Being tested
- Resistance training, Aerobic interval training
- Keywords
- Obesity, Exercise, Cardiac Fat, Cardiac Magnetic Resonance, Vascular Health
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
The resistance training group
Aerobic interval trainingOther
The aerobic interval training group
| Study group | Role | What they receive |
|---|---|---|
| Resistance training group | Experimental | Resistance training will consist of a supervised circuit training 3 sessions/week for approximately 45-50 min/session. The circuit will include 7 strength exercises engaging the major muscle groups (leg press, rows, back squats, weighted crunches, deadlifts, bench press, and squat jumps with weights). The participants will perform 3 sets of 10 repetitions with resting periods of 30 seconds between exercises, and 2 minutes between sets. The overall OMNI-Resistance Exercise Scale per set will range between 8-10. Heart rate and exercise energy expenditure during the workout will be monitored. The load will be changed depending on the participants' perception when needed. In addition, the intensity will be monitored assessing Lactate concentrations at baseline and at the end of each session. Circuit will be repeated until meeting the targeted exercise energy expenditure of 450-500 kcal/session. Receives: Other: Resistance training |
| Aerobic interval training group | 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. 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, and the second period the intensity will be reduced for 2 minutes. The speed/incline will be changed depending on the participants' heart rate and perception using the Borg's rating of perceived exertion as needed. Heart rate and exercise energy expenditure during the workout will be monitored. Intensity will be monitored assessing Lactate concentrations at the end of each session. Intervals will be repeated until meeting the targeted exercise energy expenditure (450-500 kcal/session). 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 Epicardial adipose tissue (EAT)
EAT will be measured using cardiac Magnetic Resonance
Measured: 2 assessment points: at baseline and week 4
Changes in Vascular Health
Atrial stiffness will be measured using a pulse wave analysis
Measured: 2 assessment points: at baseline and week 4
Secondary outcomes (4)
Changes in Paracardial adipose tissue (PAT)
PAT will be measured using cardiac Magnetic Resonance
Measured: 2 assessment points: at baseline and week 4
Changes in Body Composition
Body composition will be measured using dual-energy x-ray absorptiometry
Measured: 2 assessment points: at baseline and week 4
Changes in Cardiorespiratory Function
Cardiorespiratory Function will be measured on a treadmill with a metabolic cart
Measured: 2 assessment points: at baseline and week 4
Changes in Muscular Strength
Muscular Strength will be assessed by 1 repetition maximum (1RM) test
Measured: 2 assessment points: at baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Oct 2017
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Why it stopped: Covid/19
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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University Edwardsville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Fernandez del Valle, PhD, Principal investigator, Southern Illinois University of Edwardsville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297333
- Sponsor's protocol ID
- 16-1208-4C-1
- Status last verified
- Jul 2019
- First submitted
- 26 Sep 2017
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Mode on Cardiac Fat and Function
- ClinicalTrials.gov ID
- NCT03297333
- Acronym / sponsor ID
- 16-1208-4C-1
- Conditions
- Obesity
- Keywords
- Obesity, Exercise, Cardiac Fat, Cardiac Magnetic Resonance, Vascular Health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid/19
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Southern Illinois University EdwardsvilleUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 29 Sep 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 overall goal of this project is to study the effects of exercise energy expenditure matched vigorous dynamic resistance training and aerobic training on cardiac fat, and its relationship to cardiac function and geometry using cardiac Magnetic Resonance Imaging.
Detailed description
Exercise-induced weight-loss is one of the most common strategies for reducing excess fat in overweight and obese individuals. Although vigorous intensity may be more favorable promoting positive cardiac adaptations compared to low-moderate intensity, evidence of the positive effects of different exercise modes needs to be explored to allow for realistic comparisons with other strategies. Research using cardiac Magnetic Resonance Imaging that compares the effects of different modes of exercise - matched by exercise energy expenditure - on epicardial adipose tissue and paracardial adipose tissue, and how these interventions modify cardiac function and geometry have not been previously explored in obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance training group | Experimental | Other: Resistance trainingResistance training will consist of a supervised circuit training 3 sessions/week for approximately 45-50 min/session. The circuit will include 7 strength exercises engaging the major muscle groups (leg press, rows, back squats, weighted crunches, deadlifts, bench press, and squat jumps with weights). The participants will perform 3 sets of 10 repetitions with resting periods of 30 seconds between exercises, and 2 minutes between sets. The overall OMNI-Resistance Exercise Scale per set will range between 8-10. Heart rate and exercise energy expenditure during the workout will be monitored. The load will be changed depending on the participants' perception when needed. In addition, the intensity will be monitored assessing Lactate concentrations at baseline and at the end of each session. Circuit will be repeated until meeting the targeted exercise energy expenditure of 450-500 kcal/session. |
| Aerobic interval training group | 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. 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, and the second period the intensity will be reduced for 2 minutes. The speed/incline will be changed depending on the participants' heart rate and perception using the Borg's rating of perceived exertion as needed. Heart rate and exercise energy expenditure during the workout will be monitored. Intensity will be monitored assessing Lactate concentrations at the end of each session. Intervals will be repeated until meeting the targeted exercise energy expenditure (450-500 kcal/session). |
| Control group | No intervention | –Participants in the control group will not participate in the training programs. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sedentary
- Caucasian
- BMI >30 kg/m2 and < 39.9 kg/m2
Key exclusion criteria (8 listed)
- Known cardiovascular, metabolic, pulmonary disease or conditions
- Muscular-skeletal injuries
- Taking medications that affect endocrine or cardiovascular function
- Hypertension
- Being engaged in low intensity strength training more than two times per week or moderate-high intensity of any type of frequency
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 trainingThe resistance training group | Other | Resistance training group |
| Aerobic interval trainingThe aerobic interval training group | Other | Aerobic interval training group |
Primary outcome
Changes in Epicardial adipose tissue (EAT)
Time frame: 2 assessment points: at baseline and week 4
EAT will be measured using cardiac Magnetic Resonance
Changes in Vascular Health
Time frame: 2 assessment points: at baseline and week 4
Atrial stiffness will be measured using a pulse wave analysis
4 secondary outcomes
Changes in Paracardial adipose tissue (PAT)
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 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
Results and safety
The study was stopped early (reason given: Covid/19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
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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 Resistance training and 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 4 Oct 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 stopped early (reason given: Covid/19). Results are not available in the source record.
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 Epicardial adipose tissue (EAT) (time frame: 2 assessment points: at baseline and week 4). 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 4 Oct 2021.