Effects of HIIT on Metabolic Syndrome

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Metabolic Syndrome; Dyslipidemias; Blood Pressure; Sedentary Behavior
• Intervention / Treatment: Behavioral: Low Volume-High Intensity Interval Training; Behavioral: Moderate Intensity Continuous Training

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ismael Serrablo, MSc; Phone Number: 0034652950339; Email: serrabli@uni.coventry.ac.uk

Study Locations

• Spain
  • Madrid, Spain, 28003
    • CDM GO fit Vallehermoso
    • Principal Investigator: Ismael Serrablo, MsC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LV-High Intensity Interval Training; 2 x 4 minutes at 85%-95% of Heart rate max.	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; Other Names: HIIT; LV-HIIT
Experimental: Moderate Intensity Continuous Training; 1 x 45 minutes at 65%-75% of Heart rate max.	Behavioral: 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.; Other Names: MICT
No Intervention: Control Group; They will not be prescribed any training and will be asked to continue with their normal lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Blood Pressure (mmHg)	Evaluate change in Systolic and Diastolic Blood Pressure	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.	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.	0 to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Coventry University
• Collaborators: INGESPORT HEALTH AND SPA CONSULTING SL
• Investigators: Study Director: Elizabeth Horton, PhD, Coventry University; Study Director: Alfonso Jimenez, PhD, GOfit and Sheffield Hallam University; Principal Investigator: Ismael Serrablo, MSc, Coventry University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): March 2, 2020
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Exercise Training; High Intensity Interval Training; HIIT; Interval Training; Medium Intensity Continuous Training
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Lipid Metabolism Disorders; Syndrome; Metabolic Syndrome; Dyslipidemias
• Other Study ID Numbers: P72554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No