Effects of HIIT on Metabolic Syndrome

Obesity Clinical Trial

Official title:

Study of the Effects of a Structured Training Program on People at Risk of Developing Metabolic Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04133129
• Other study ID #: P72554
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: October 2019
• Source: Coventry University
• Contact: Ismael Serrablo, MSc
• Phone: 0034652950339
• Email: serrabli[@]uni.coventry.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Subjects participating in the project will undergo a series of tests before and after the training intervention which will allow us to make conclusions.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: March 31, 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Dyslipidemias
• Metabolic Syndrome
• Obesity
• Sedentary Behavior
• Syndrome

Intervention

Behavioral:
• Low Volume-High Intensity Interval Training
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 Training
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.

Locations

Country	Name	City	State
Spain	CDM GO fit Vallehermoso	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Coventry University	INGESPORT HEALTH AND SPA CONSULTING SL

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	0 to 12 weeks
Primary	Blood Pressure (mmHg)	Evaluate change in Systolic and Diastolic Blood Pressure	0 to 12 weeks
Primary	Cardiorespiratory Fitness (ml/kg/min)	Evaluate change in maximal oxygen uptake (VO2max) via breath by breath analysis performed on a treadmill.	0 to 12 weeks
Primary	Changes in Body Composition (kg)	Evaluate changes in Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis.	0 to 12 weeks
Secondary	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:"	0 to 12 weeks
Secondary	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	0 to 12 weeks