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Clinical Trials/NCT04133129
NCT04133129
Unknown
Not Applicable

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

Coventry University1 site in 1 country180 target enrollmentNovember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dyslipidemias
Sponsor
Coventry University
Enrollment
180
Locations
1
Primary Endpoint
Blood Pressure (mmHg)
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
March 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ismael Serrablo

Principle Investigator

Coventry University

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

Outcomes

Primary Outcomes

Blood Pressure (mmHg)

Time Frame: 0 to 12 weeks

Evaluate change in Systolic and Diastolic Blood Pressure

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.

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).

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 Outcomes

  • Changes in exercise enjoyment(0 to 12 weeks)
  • Change in Behavioural Regulations in Exercise Questionnaire-2 (BREQ-2) over time(0 to 12 weeks)

Study Sites (1)

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