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临床试验/NCT04133129
NCT04133129Unknown不适用

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

Coventry University2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2019年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
180
试验地点
2
主要终点
Blood Pressure (mmHg)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

LV-High Intensity Interval Training

Experimental

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

干预措施: Low Volume-High Intensity Interval Training (Behavioral)

Moderate Intensity Continuous Training

Experimental

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

干预措施: Moderate Intensity Continuous Training (Behavioral)

Control Group

No Intervention

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

结局指标

主要结局

Blood Pressure (mmHg)

时间窗: 0 to 12 weeks

Evaluate change in Systolic and Diastolic Blood Pressure

Cardiorespiratory Fitness (ml/kg/min)

时间窗: 0 to 12 weeks

Evaluate change in maximal oxygen uptake (VO2max) via breath by breath analysis performed on a treadmill.

Biochemical: Lipid Profile

时间窗: 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)

时间窗: 0 to 12 weeks

Evaluate changes in Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ismael Serrablo

Principle Investigator

Coventry University

研究点 (2)

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