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Effects of HIIT on Metabolic Syndrome

Primary Purpose

Dyslipidemias, Metabolic Syndrome, Sedentary Behavior

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Low Volume-High Intensity Interval Training
Moderate Intensity Continuous Training
Sponsored by
Coventry University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dyslipidemias focused on measuring HIIT, High Intensity Interval Training, Medium Intensity Continuous Training, Interval Training, Exercise, Physical Activity, Exercise Training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CDM GO fit Vallehermoso

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

LV-High Intensity Interval Training

Moderate Intensity Continuous Training

Control Group

Arm Description

2 x 4 minutes at 85%-95% of Heart rate max.

1 x 45 minutes at 65%-75% of Heart rate max.

They will not be prescribed any training and will be asked to continue with their normal lifestyle.

Outcomes

Primary Outcome Measures

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).
Blood Pressure (mmHg)
Evaluate change in Systolic and Diastolic Blood Pressure
Cardiorespiratory Fitness (ml/kg/min)
Evaluate change in maximal oxygen uptake (VO2max) via breath by breath analysis performed on a treadmill.
Changes in Body Composition (kg)
Evaluate changes in Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis.

Secondary Outcome Measures

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:"
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

Full Information

First Posted
October 16, 2019
Last Updated
October 18, 2019
Sponsor
Coventry University
Collaborators
INGESPORT HEALTH AND SPA CONSULTING SL
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1. Study Identification

Unique Protocol Identification Number
NCT04133129
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Anticipated)
Primary Completion Date
March 2, 2020 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coventry University
Collaborators
INGESPORT HEALTH AND SPA CONSULTING SL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are only assigned to one of 3 possible groups for the duration of the intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LV-High Intensity Interval Training
Arm Type
Experimental
Arm Description
2 x 4 minutes at 85%-95% of Heart rate max.
Arm Title
Moderate Intensity Continuous Training
Arm Type
Experimental
Arm Description
1 x 45 minutes at 65%-75% of Heart rate max.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
They will not be prescribed any training and will be asked to continue with their normal lifestyle.
Intervention Type
Behavioral
Intervention Name(s)
Low Volume-High Intensity Interval Training
Other Intervention Name(s)
HIIT, LV-HIIT
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Moderate Intensity Continuous Training
Other Intervention Name(s)
MICT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Biochemical: Lipid Profile
Description
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).
Time Frame
0 to 12 weeks
Title
Blood Pressure (mmHg)
Description
Evaluate change in Systolic and Diastolic Blood Pressure
Time Frame
0 to 12 weeks
Title
Cardiorespiratory Fitness (ml/kg/min)
Description
Evaluate change in maximal oxygen uptake (VO2max) via breath by breath analysis performed on a treadmill.
Time Frame
0 to 12 weeks
Title
Changes in Body Composition (kg)
Description
Evaluate changes in Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis.
Time Frame
0 to 12 weeks
Secondary Outcome Measure Information:
Title
Changes in exercise enjoyment
Description
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:"
Time Frame
0 to 12 weeks
Title
Change in Behavioural Regulations in Exercise Questionnaire-2 (BREQ-2) over time
Description
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
Time Frame
0 to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ismael Serrablo, MSc
Phone
0034652950339
Email
serrabli@uni.coventry.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Horton, PhD
Organizational Affiliation
Coventry University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alfonso Jimenez, PhD
Organizational Affiliation
GOfit and Sheffield Hallam University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ismael Serrablo, MSc
Organizational Affiliation
Coventry University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CDM GO fit Vallehermoso
City
Madrid
ZIP/Postal Code
28003
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ismael Serrablo, MsC

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of HIIT on Metabolic Syndrome

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