Obesity Clinical Trial
Official title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | CDM GO fit Vallehermoso | Madrid |
Lead Sponsor | Collaborator |
---|---|
Coventry University | INGESPORT HEALTH AND SPA CONSULTING SL |
Spain,
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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