The Effect of (i) Physical Activity and (ii) Continuous Versus Intermittent Exercise Training Upon Cardiovascular and Cognitive Function in Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Maximal oxygen uptake (CPX)
研究概览
简要总结
One hundred participants from a combination of (a) local advertisements and/or (b) those whose details are held on a research database (of previous volunteers indicating willingness to be contacted about future studies) will be sought to volunteer for this study. Written informed consent will be gained following greater than 48 hours for the purpose of reading the Participant Information sheets. The study will then involve two stages (i) recruiting participants for a cross sectional analysis of the relationship between physical activity levels and cardiovascular and cognitive function, and (ii) a longer exercise training study in a subsample of these volunteers (i.e. participants who volunteer to exercise train). Participants for stage 1 will then visit the laboratory in the University on three occasions (over a three week period) to be assessed for body composition, exercise tolerance, current physical activity levels, cognitive function and arterial and cardiac health. Each visit will last for 60 - 90 minutes. Participants will then be provided with an accelerometer to wear for a period of one week in order to assess movement counts and sedentary behaviour. Stage 2 will include only those participants who have volunteered for the exercise training component (approx 60). These participants will then be randomly divided into two groups. Both groups will exercise three times per week for 12 weeks duration. Group 1 will exercise in a traditional manner at a moderate intensity, whilst the second group will exercise at a heavy intensity but in short bursts. Both groups will complete the same amount of work but in two differing modes. Both groups will attend the laboratory twice per week for supervised exercise sessions and also perform one home based 30 minute brisk walk per week. All participants will be re-examined at 12 weeks.
详细描述
The study will involve two stages (i) recruiting participants for a cross sectional analysis of the relationship between physical activity levels and cardiovascular and cognitive function, and (ii) a longer exercise training study in a subsample of these volunteers. 100 participants for stage 1 will visit the laboratory in the University on three occasions (within a three week period) to be assessed for anthropometric outcomes, body composition, exercise tolerance, cognitive function and arterial and cardiac health. Each visit will last for 60 - 90 minutes. Participants will then be provided with an accelerometer to wear for a period of one week in order to assess movement counts and sedentary behaviour. Stage 2 will include only those participants who are happy to continue into the exercise training phase. These participants will then be matched for age and BMI and then randomly (on matched pairs) allocated to one of two groups. Both groups will exercise three times per week for 12 weeks duration. Group 1 will exercise in a traditional manner undertaking continuous exercise, whilst the Group 2 will exercise at a heavy intensity but in short bursts (interval exercise). Both groups will complete the same amount of work but in two differing modes. Both groups will attend the laboratory twice per week for supervised exercise sessions and also perform one home based 30 minute brisk walk per week. All participants will be re-examined at 12 weeks.
Recruitment of participants
One hundred participants from a combination of (a) local advertisements and/or (b) those whose details are held on a research database (of previous volunteers indicating willingness to be contacted about future studies) will be sought to volunteer for this study. Participants will be contacted via email/telephone/letter to provide information regarding this study. All volunteers interested in participating will be contacted to provide general information during a preliminary telephone screening interview. This will be used to check main inclusion and exclusion criteria. The women who fit these criteria will be sent the participant information sheet to read carefully and if still interested invited to attend the first laboratory visit for a screening session. Participants have greater than 48 hours to assess the participant information sheet before they attend this first visit when, if eligible, they will be asked to provide written informed consent.
Laboratory Visits
Visit 1
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
- 35 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sedentary women (exercise ≤2 day per week)
- •Pre-menopausal (age 35- 50 years)
- •BMI of ≥30 kg/m2
- •Able to give informed consent .
- •Non-smokers
- •Vision sufficiently good to complete the cognitive testing (using glasses and/or lenses).
排除标准
- •BMI < 30 kg/m2
- •Clinically diagnosed with type 1 or type 2 diabetes
- •Resting/exercise ECG indicating significant ischemia, recent myocardial infarction or other acute cardiac event or other exercise related ECG abnormalities.
- •Unstable angina.
- •Uncontrolled hypertension.
- •Uncontrolled cardiac dysrhythmias
- •The use of antidepressant, antianxiety, or thyroid medication.
- •Neurological disorder
- •Previous stroke or Transient Ischaemic Attack (TIA)
- •Musculoskeletal impairment or injury
- •Medication that has a direct effect on the brain and is likely to influence cognitive function.
- •Current smokers or those who have given up in the previous 6 months
结局指标
主要结局
Maximal oxygen uptake (CPX)
时间窗: Change at 12 weeks
Maximal oxygen uptake assessed during a ramp incremental cycle ergometry test.
Flow mediated dilatation
时间窗: Change at 12 weeks
Percentage change in brachial artery diameter following cuff occlusion using doppler ultrasound.
次要结局
- Cognitive function (Grooved peg board)(Baseline and 12 weeks)
- Cognitive function (Visual verbal learning scale)(Baseline and 12 weeks)
- Cognitive function (Bakan test))(Baseline and 12 weeks)
- Cognitive function (Corsi block tapping)(Baseline and 12 weeks)
- Physical activity level(Baseline and 12 weeks)
- Body composition(Baseline and 12 weeks)
- Blood pressure(Baseline and 12 weeks)
- Cardiac structure (echocardiography)(Baseline and 12 weeks)
- Adhesion of cultured angiogenic cells to vascular smooth muscle cells(Baseline and 12 weeks)
- Lactate threshold(Baseline and 12 weeks)
- Blood borne (plasma) inflammatory marker(Baseline and 12 weeks)
- Work rate peak(Baseline and 12 weeks)
- Circulating angiogenic cell number(Baseline and 12 weeks)
- Circulating cytokines(Baseline and 12 weeks)
- Arterial stiffness(Baseline and 12 weeks)
- Cognitive function (Visual spatial learning scale)(Baseline and 12 weeks)
- Cognitive function (Tower of Hanoi)(Baseline and 12 weeks)
- Cardiac function (echocardiography)(Baseline and 12 weeks)
研究者
Karen Birch
Chief Investigator
University of Leeds