Clinical trial NCT04133129: Effects of HIIT on Metabolic Syndrome
Official title: Study of the Effects of a Structured Training Program on People at Risk of Developing Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Coventry University
Sponsor class: OTHER
Collaborators: name: INGESPORT HEALTH AND SPA CONSULTING SL
First posted: 2019-10-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are only assigned to one of 3 possible groups for the duration of the intervention.
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Biochemical: Lipid Profile
timeFrame: 0 to 12 weeks
measure: Blood Pressure (mmHg)
timeFrame: 0 to 12 weeks
measure: Cardiorespiratory Fitness (ml/kg/min)
timeFrame: 0 to 12 weeks
measure: Changes in Body Composition (kg)
timeFrame: 0 to 12 weeks
Secondary outcomes:
measure: Changes in exercise enjoyment
timeFrame: 0 to 12 weeks
measure: Change in Behavioural Regulations in Exercise Questionnaire-2 (BREQ-2) over time
timeFrame: 0 to 12 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CDM GO fit Vallehermoso
Study officials:
affiliation: Coventry University
name: Elizabeth Horton, PhD
role: STUDY_DIRECTOR
affiliation: GOfit and Sheffield Hallam University
name: Alfonso Jimenez, PhD
role: STUDY_DIRECTOR
affiliation: Coventry University
name: Ismael Serrablo, MSc
role: PRINCIPAL_INVESTIGATOR
References: