DyslipidemiasNCT04133129
Effects of HIIT on Metabolic Syndrome
A study testing Low Volume-High Intensity Interval Training and Moderate Intensity Continuous Training in people with Dyslipidemias and Metabolic Syndrome, run by Coventry University at 1 site in Spain.
Trial summary
The project aims to find out the differences between two different types of structured training interventions have on the lipid profile of persons with diagnosed dyslipidemia. Each training intervention will last for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Metabolic Syndrome, Sedentary Behavior
- What is being tested?
- Low Volume-High Intensity Interval Training and Moderate Intensity Continuous Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2019to 31 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fasted Blood Glucose >100 mg/dL
- Total Cholesterol >200 mg/dL
- Blood Pressure >130/90 mmHg
- Do not partake in more than 150 min/week of moderate to vigorous exercise
Who cannot join
- Existing or past medical history of vascular disease, cancer, diabetes, osteoporosis, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease.
- Musculoskeletal injuries
- Neuromuscular disorders or injuries
- Individuals with a pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effects of a Structured Training Program on People at Risk of Developing Metabolic Syndrome
The project aims to find out the differences between two different types of structured training interventions have on the lipid profile of persons with diagnosed dyslipidemia. Each training intervention will last for 12 weeks. Subjects participating in the project will undergo a series of tests before and after the training intervention which will allow us to make conclusions.
Read the detailed description
The purpose of this project is to compare the effect that two different types of aerobic training modes have on the lipid profile of subjects with pre-symptoms of metabolic syndrome. One training mode will involve High-Intensity Interval Training and the other will involve medium intensity continuous training. The desired outcomes of this project are to know the effects of both modes of training have on the long-term on the lipid profile in order to help develop a nonpharmacologic alternative to prevent or treat metabolic syndrome and to know how affective and enjoyment responses are affected by the different modes of training. The Project lasts for 16 weeks. Training will take place during weeks 3 and 14 of the project. The project will be described fully to the participants during the 1st week. In addition to this, their rights as participants will be explained in addition to any possible ethical issues that might require clarifying. Once the subjects have agreed to take part in the research they will undergo a series of tests in order to asses their cardiorespiratory fitness and their lipids profile. Before starting the training intervention participants will be randomly assigned to one of the 3 different groups; Control, Medium Intensity Continuous Training and Low Volume High-Intensity Interval Training. Between weeks 3 and 14 subjects will take part in 3 training sessions per week. At week 15 and 16 subjects will undergo the same tests as during week 1 and 2.
- Conditions
- Dyslipidemias, Metabolic Syndrome, Sedentary Behavior, Obesity, Blood Pressure
- Being tested
- Low Volume-High Intensity Interval Training, Moderate Intensity Continuous Training
- Keywords
- HIIT, High Intensity Interval Training, Medium Intensity Continuous Training, Interval Training, Exercise, Physical Activity, Exercise Training
- Medical subject headings
- Dyslipidemias, Metabolic Syndrome, Sedentary Behavior, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Volume-High Intensity Interval TrainingBehavioural
Also called HIIT, LV-HIIT
On a treadmill, a 2 minute warm-up will be followed by 2 bouts of 4 minutes at an intensity between 85% and 95% of Maximum Heart Rate (HRmax) interspersed by a 2 minutes recovery bout at 70% of heart rate max, followed by a 3 minutes Cool Down
Moderate Intensity Continuous TrainingBehavioural
Also called MICT
On a treadmill,a 2-minute warm-up will be followed by 45 minutes at 65%-75% of Heart Rate max followed by 3 minutes cool down.
| Study group | Role | What they receive |
|---|---|---|
| LV-High Intensity Interval Training | Experimental | 2 x 4 minutes at 85%-95% of Heart rate max. Receives: Behavioral: Low Volume-High Intensity Interval Training |
| Moderate Intensity Continuous Training | Experimental | 1 x 45 minutes at 65%-75% of Heart rate max. Receives: Behavioral: Moderate Intensity Continuous Training |
| Control Group | No intervention | They will not be prescribed any training and will be asked to continue with their normal lifestyle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical: Lipid Profile
Evaluate change in Very Low-Density Lipoproteins (VLDL), High Density Lipoprotein (HDL), and Low-Density Lipoprotein (LDL) in (mg/dl) with Liposcale® test, an advanced lipoprotein test based on 2D Nuclear Magnetic Resonance (NMR).
Measured: 0 to 12 weeks
Blood Pressure (mmHg)
Evaluate change in Systolic and Diastolic Blood Pressure
Measured: 0 to 12 weeks
Cardiorespiratory Fitness (ml/kg/min)
Evaluate change in maximal oxygen uptake (VO2max) via breath by breath analysis performed on a treadmill.
Measured: 0 to 12 weeks
Changes in Body Composition (kg)
Evaluate changes in Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis.
Measured: 0 to 12 weeks
Secondary outcomes (2)
Changes in exercise enjoyment
The investigators will assess perceived exercise enjoyment at baseline and post intervention using The Physical Activity Enjoyment Scale (PACES). (PACES) is an 18-item measure, scored on a 7-point bipolar scale based on the instruction; "Please rate how you feel at the moment about the physical activity you have been doing:"
Measured: 0 to 12 weeks
Change in Behavioural Regulations in Exercise Questionnaire-2 (BREQ-2) over time
Behavioural Regulations in Exercise Questionnaire-2 (BREQ-2) is a 19 item self-report scale. It uses a Likert-type scale of 5 points, where 0 = not true for me and 4 = very true for me
Measured: 0 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion2 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are only assigned to one of 3 possible groups for the duration of the intervention.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coventry University
- Sponsor type
- University, hospital or other
- Collaborators
- INGESPORT HEALTH AND SPA CONSULTING SL
- Responsible party
- Principal investigator, Ismael Serrablo, Coventry University
- Investigators
- Elizabeth Horton, PhD, Study director, Coventry UniversityAlfonso Jimenez, PhD, Study director, GOfit and Sheffield Hallam UniversityIsmael Serrablo, MSc, Principal investigator, Coventry University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133129
- Sponsor's protocol ID
- P72554
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- 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 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of a Structured Training Program on People at Risk of Developing Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT04133129
- Acronym / sponsor ID
- P72554
- Conditions
- Dyslipidemias, Metabolic Syndrome, Sedentary Behavior, Obesity, Blood Pressure
- Keywords
- HIIT, High Intensity Interval Training, Medium Intensity Continuous Training, Interval Training, Exercise, Physical Activity, Exercise Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Coventry UniversityUniversity, hospital or other
- Collaborators
- INGESPORT HEALTH AND SPA CONSULTING SL
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 2 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 21 Oct 2019 (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 project aims to find out the differences between two different types of structured training interventions have on the lipid profile of persons with diagnosed dyslipidemia. Each training intervention will last for 12 weeks. Subjects participating in the project will undergo a series of tests before and after the training intervention which will allow us to make conclusions.
Detailed description
The purpose of this project is to compare the effect that two different types of aerobic training modes have on the lipid profile of subjects with pre-symptoms of metabolic syndrome. One training mode will involve High-Intensity Interval Training and the other will involve medium intensity continuous training. The desired outcomes of this project are to know the effects of both modes of training have on the long-term on the lipid profile in order to help develop a nonpharmacologic alternative to prevent or treat metabolic syndrome and to know how affective and enjoyment responses are affected by the different modes of training. The Project lasts for 16 weeks. Training will take place during weeks 3 and 14 of the project. The project will be described fully to the participants during the 1st week. In addition to this, their rights as participants will be explained in addition to any possible ethical issues that might require clarifying. Once the subjects have agreed to take part in the research they will undergo a series of tests in order to asses their cardiorespiratory fitness and their lipids profile. Before starting the training intervention participants will be randomly assigned to one of the 3 different groups; Control, Medium Intensity Continuous Training and Low Volume High-Intensity Interval Training. Between weeks 3 and 14 subjects will take part in 3 training sessions per week. At week 15 and 16 subjects will undergo the same tests as during week 1 and 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are only assigned to one of 3 possible groups for the duration of the intervention.
| Arm | Type | Receives |
|---|---|---|
| LV-High Intensity Interval Training | Experimental | Behavioral: Low Volume-High Intensity Interval Training2 x 4 minutes at 85%-95% of Heart rate max. |
| Moderate Intensity Continuous Training | Experimental | Behavioral: Moderate Intensity Continuous Training1 x 45 minutes at 65%-75% of Heart rate max. |
| Control Group | No intervention | –They will not be prescribed any training and will be asked to continue with their normal lifestyle. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fasted Blood Glucose >100 mg/dL
- Total Cholesterol >200 mg/dL
- Blood Pressure >130/90 mmHg
- Do not partake in more than 150 min/week of moderate to vigorous exercise
Key exclusion criteria (4 listed)
- Existing or past medical history of vascular disease, cancer, diabetes, osteoporosis, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease.
- Musculoskeletal injuries
- Neuromuscular disorders or injuries
- Individuals with a pacemaker
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 |
|---|---|---|
| Low Volume-High Intensity Interval TrainingAlso: HIIT, LV-HIITOn a treadmill, a 2 minute warm-up will be followed by 2 bouts of 4 minutes at an intensity between 85% and 95% of Maximum Heart Rate (HRmax) interspersed by a 2 minutes recovery bout at 70% of heart rate max, followed by a 3 minutes Cool Down | Behavioural | LV-High Intensity Interval Training |
| Moderate Intensity Continuous TrainingAlso: MICTOn a treadmill,a 2-minute warm-up will be followed by 45 minutes at 65%-75% of Heart Rate max followed by 3 minutes cool down. | Behavioural | Moderate Intensity Continuous Training |
Primary outcome
Biochemical: Lipid Profile
Time frame: 0 to 12 weeks
Evaluate change in Very Low-Density Lipoproteins (VLDL), High Density Lipoprotein (HDL), and Low-Density Lipoprotein (LDL) in (mg/dl) with Liposcale® test, an advanced lipoprotein test based on 2D Nuclear Magnetic Resonance (NMR).
Blood Pressure (mmHg)
Time frame: 0 to 12 weeks
Evaluate change in Systolic and Diastolic Blood Pressure
Cardiorespiratory Fitness (ml/kg/min)
Time frame: 0 to 12 weeks
Evaluate change in maximal oxygen uptake (VO2max) via breath by breath analysis performed on a treadmill.
Changes in Body Composition (kg)
Time frame: 0 to 12 weeks
Evaluate changes in Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis.
2 secondary outcomes
Changes in exercise enjoyment
Time frame: 0 to 12 weeks
Change in Behavioural Regulations in Exercise Questionnaire-2 (BREQ-2) over time
Time frame: 0 to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- 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.
Elizabeth Horton, PhD study director
Coventry University
Alfonso Jimenez, PhD study director
GOfit and Sheffield Hallam University
Ismael Serrablo, MSc principal investigator
Coventry 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 Low Volume-High Intensity Interval Training and Moderate Intensity Continuous Training in people with Dyslipidemias and Metabolic Syndrome, run by Coventry University at 1 site in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Oct 2019. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ismael Serrablo, MSc (0034652950339, serrabli@uni.coventry.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical: Lipid Profile (time frame: 0 to 12 weeks). The study lists 4 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 Oct 2019.