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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04133129
Other study ID # P72554
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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