Combining Physical Activity and Sedentary Interventions to Improve Cardiometabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Homeostatic model assessment for insulin resistance (HOMA-IR)
研究概览
简要总结
Many adults spend a large part of their day sitting, especially at work. Long periods of sitting and not moving enough can increase the risk of health problems such as heart disease and type 2 diabetes. This risk is even higher in people who have early warning signs like being overweight, having high blood pressure, or problems with blood sugar. Together, these problems are called metabolic syndrome.
The goal of this study is to find out whether combining regular exercise with reducing sitting time during the day can improve heart and metabolic health more than exercise alone.
About 40 adults between 18 and 65 years old who work mainly at a desk and sit for more than 9 hours a day will take part. All participants will first continue their normal daily routine for two weeks. After that, they will be randomly placed into one of two groups for eight weeks:
Exercise group: Participants will follow the World Health Organization guidelines for physical activity. This includes two sessions of moderate exercise each week (such as brisk walking or cycling) and one session of more intense exercise each week.
Exercise plus less sitting group: Participants will do the same exercise program, but they will also be encouraged to sit less during the workday. They will be asked to stand more, use sit-stand desks if possible, and avoid sitting for longer than one hour at a time.
Participants will visit the research center three times for health tests. These tests include blood samples to look at blood sugar, insulin, and fats in the blood, measurements of blood pressure and heart function, body composition scans, fitness tests, and questionnaires about sleep, diet, and quality of life. They will also wear activity monitors to measure how much they sit, stand, and move.
The main outcome is how the body handles sugar (insulin sensitivity). The researchers hope to learn whether sitting less, in addition to exercising, leads to better improvements in heart and metabolic health. The results may help develop better lifestyle advice to prevent heart disease and diabetes in people with desk jobs.
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
- 是
入选标准
- •Age 18 to 65 years
- •Profession where most of the time is spent sitting.
- •Not regularly physically active (>3 trainings per week in the last three months)
- •Sedentary (on average >9 hours per day spent sedentary on a working day)
- •Written informed consent to participate in the study.
排除标准
- •Pregnancy.
- •Consumption of more than 20 units of alcohol per week.
- •Medical conditions that limit physical activity.
- •Specific diet (e.g. low-carbohydrate or calorie-restricted).
- •Unstable body weight in the past month.
- •Participation in another study that could potentially affect your blood parameters in the past month.
研究组 & 干预措施
Control arm (2 weeks)
All participants will follow a two-week period where no intervention is administered.
PA group (8 weeks)
After the control period without intervention, one halve of the participants is randomised to the PA group where participants are encouraged to adhere to WHO physical activity guidelines during 8 weeks.
干预措施: WHO physical activity guideline (Behavioral)
PA-SB group (8 weeks)
After the control period without intervention, one halve of the participants is randomised to the PA-SB group where participants are encouraged to adhere to WHO physical activity guidelines. In addition, sedentary time at the workplace is reduced. The duration of this intervention is 8 weeks.
干预措施: WHO physical activity guideline (Behavioral)
PA-SB group (8 weeks)
After the control period without intervention, one halve of the participants is randomised to the PA-SB group where participants are encouraged to adhere to WHO physical activity guidelines. In addition, sedentary time at the workplace is reduced. The duration of this intervention is 8 weeks.
干预措施: Sedentary behaviour reduction at the workplace (Behavioral)
结局指标
主要结局
Homeostatic model assessment for insulin resistance (HOMA-IR)
时间窗: From enrollment to the end of the intervention at 8 weeks.
The HOMA-IR is calculated from the fasting insulin and glucose concentration.
Whole-body insulin sensitivity index (ISI)
时间窗: From enrollment to the end of the intervention at 8 weeks
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity using the whole-body insulin sensitivity index (ISI). The ISI is calculated from both insulin and glucose concentrations.
Area under the curve of insulin concentrations
时间窗: From enrollment to the end of the intervention at 8 weeks
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity by calculation of the area under the curve of insulin concentrations.
Insulinogenic index
时间窗: From enrollment to the end of the intervention at 8 weeks.
An oral glucose tolerance test will be performed for assessment of beta cell function by calculation of the insulinogenic index. The insulinogenic index is calculated from both insulin and glucose concentrations.
次要结局
- Body composition(From enrollment to the end of the intervention at 8 weeks.)
- Cardiorespiratory Fitness(From enrollment to the end of the intervention at 8 weeks.)
- Area under the curve of glucose concentrations(From enrollment to the end of the intervention at 8 weeks)
- Steps per day(From enrollment to the end of the intervention at 8 weeks. For one week during the first four weeks of the intervention. For one week during the last four weeks of the intervention.)
- Sitting time(From enrollment to the end of the intervention at 8 weeks. For one week during the first four weeks of the intervention. For one week during the last four weeks of the intervention.)
- Moderate to vigorous physical activity(From enrollment to the end of the intervention at 8 weeks. For one week during the first four weeks of the intervention. For one week during the last four weeks of the intervention.)
- Light intensity physical activity(From enrollment to the end of the intervention at 8 weeks. For one week during the first four weeks of the intervention. For one week during the last four weeks of the intervention.)
- Sleep(From enrollment to the end of the intervention at 8 weeks. For one week during the first four weeks of the intervention. For one week during the last four weeks of the intervention.)
- Body weight(From enrollment to the end of the intervention at 8 weeks)
- Height(From enrollment to the end of the intervention at 8 weeks.)
- Body mass index(From enrollment to the end of the intervention at 8 weeks)
- Waist and hip circumference(From enrollment to the end of the intervention at 8 weeks)
- Blood pressure(From enrollment to the end of the intervention at 8 weeks)
- Vascular endothelial function(From enrollment to the end of the intervention at 8 weeks)
- Cardiac autonomic function(From enrollment to the end of the intervention at 8 weeks)
- Concentration of glucose(From enrollment to the end of the intervention at 8 weeks)
- Concentration of insulin(From enrollment to the end of the intervention at 8 weeks.)
- Concentration of total cholesterol(From enrollment to the end of the intervention at 8 weeks.)
- Concentration of Low-Density Lipoprotein cholesterol(From enrollment to the end of the intervention at 8 weeks.)
- Concentration of High-Density Lipoprotein cholesterol(From enrollment to the end of the intervention at 8 weeks.)
- Concentration of triglycerides(From enrollment to the end of the intervention at 8 weeks.)
- Concentration of apolipoproteins(From enrollment to the end of the intervention at 8 weeks.)
- Concentration of CRP(From enrollment to the end of the intervention at 8 weeks.)
- Concentration of Interleukin 6 (IL-6)(From enrollment to the end of the intervention at 8 weeks.)
- Concentration of interleukin 1 (IL-1)(From enrollment to the end of the intervention at 8 weeks.)
- Sleep quality(From enrollment to the end of the intervention at 8 weeks.)
- Food intake(From enrollment to the end of the intervention at 8 weeks)
- Quality of life (QOL)(From enrollment to the end of the intervention at 8 weeks)
研究者
Bert Op't Eijnde
Prof Dr. Bert Op 't Eijnde
Hasselt University