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Effects of HIIT on Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT04133129
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
INGESPORT HEALTH AND SPA CONSULTING SL
Information provided by (Responsible Party):
Ismael Serrablo, Coventry University

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.

Condition or disease Intervention/treatment Phase
Dyslipidemias Metabolic Syndrome Sedentary Behavior Obesity Blood Pressure Behavioral: Low Volume-High Intensity Interval Training Behavioral: Moderate Intensity Continuous Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are only assigned to one of 3 possible groups for the duration of the intervention.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of the Effects of a Structured Training Program on People at Risk of Developing Metabolic Syndrome
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : March 2, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


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 Name: MICT

No Intervention: Control Group
They will not be prescribed any training and will be asked to continue with their normal lifestyle.



Primary Outcome Measures :
  1. 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).

  2. Blood Pressure (mmHg) [ Time Frame: 0 to 12 weeks ]
    Evaluate change in Systolic and Diastolic Blood Pressure

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Changes in exercise enjoyment [ Time Frame: 0 to 12 weeks ]
    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:"

  2. Change in Behavioural Regulations in Exercise Questionnaire-2 (BREQ-2) over time [ Time Frame: 0 to 12 weeks ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133129


Contacts
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Contact: Ismael Serrablo, MSc 0034652950339 serrabli@uni.coventry.ac.uk

Locations
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Spain
CDM GO fit Vallehermoso Not yet recruiting
Madrid, Spain, 28003
Principal Investigator: Ismael Serrablo, MsC         
Sponsors and Collaborators
Coventry University
INGESPORT HEALTH AND SPA CONSULTING SL
Investigators
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Study Director: Elizabeth Horton, PhD Coventry University
Study Director: Alfonso Jimenez, PhD GOfit and Sheffield Hallam University
Principal Investigator: Ismael Serrablo, MSc Coventry University

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Responsible Party: Ismael Serrablo, Principle Investigator, Coventry University
ClinicalTrials.gov Identifier: NCT04133129     History of Changes
Other Study ID Numbers: P72554
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ismael Serrablo, Coventry University:
HIIT
High Intensity Interval Training
Medium Intensity Continuous Training
Interval Training
Exercise
Physical Activity
Exercise Training
Additional relevant MeSH terms:
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Metabolic Syndrome
Dyslipidemias
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders