The Effect of Mixed Aerobic and Strength Training Program on Physical Fitness and Cerebrovascular Function in Older Women With Metabolic Syndrome: A Pilot Study With Randomized Control Trial (RCT) Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Maximal Oxygen Uptake
研究概览
简要总结
The purpose of this study is to test whether a supervised mixed aerobic and strength training (MAST) program is effective in improving overall physical fitness and blood flow in the brain and lowering risk factors of coronary artery disease (CAD) in women with metabolic syndrome.
详细描述
Metabolic syndrome is a cluster of conditions and disorders that increase the risk for coronary artery disease (CAD) and strokes. Sedentary lifestyle is one of the risk factors, which decrease overall physical fitness and together with aging may lead to decrease in physical functioning in everyday life as well as changes in blood flow in the brain and cognitive functions. Regular physical activity is associated with a reduced risk of cardiovascular disease. It may also improve blood flow velocity and cognitive functions. Physical activity should be as effective as possible, but also as safe as possible. Supervised mixed aerobic and strength training (MAST) program for 4 months enables to individualize the intensity of aerobic exercise based on measured maximal exercise capacity. Throughout each training session heart rate will be monitored with a new real time wireless ECG system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women
- •Age 50 or over
- •Diagnosed metabolic syndrome
排除标准
- •Any unstable or acute medical condition that the study physician deem unsafe for participation
- •Positive stress test for CAD or other ischemic conditions
- •Myocardial infarction or major surgery within 6 months
- •History of a clinically documented stroke
- •Clinical dementia (by history) or inability to follow details of the protocol
- •Carotid stenosis > 50% by medical history
- •Insulin dependent diabetes mellitus (also type II, if using insulin) or history of severe hypoglycemic episodes within 6 months requiring hospitalization
- •Liver or renal failure or transplant
- •Severe blood pressure elevation (systolic BP > 180 and/or diastolic BP > 110 mm Hg)
- •Anemia (Hb < 10)
- •Seizure disorders
- •Current recreational drug or alcohol abuse
- •BMI > 45, but body weight under 280 lbs
- •Inability to obtain permission for participation from the primary care physician
- •Clinically significant and movement limiting hip, knee and/or back disorders or injury, and rheumatoid arthritis
- •Transcranial Doppler (TCD) exclusion criteria - poor insonation window and TCD signal
研究组 & 干预措施
MAST program
Mixed Aerobic and Strength Training program (MAST): Each exercise session consisted of 10 minutes of warm-up, 15-30 minutes of interval aerobic training by cycle ergometer according to the program, 20 minutes of strength training exercises, and 10 minutes of cool-down by stretching.
干预措施: MAST program (Behavioral)
UC
Usual Care (UC) with Educational Lectures: No exercise sessions.
结局指标
主要结局
Maximal Oxygen Uptake
时间窗: At baseline and after 4 months of intervention
To obtain peak oxygen uptake (VO2max; ml-1/min-1/kg), a symptom-limited exercise stress test was performed on a cycle ergometer. The test was preceded by a 2-minute warm-up at the intensity of 20 W. The first test load was 20 W, and was increased by 20 W at each 2-minute stage until the participants could no longer continue, i.e., they were unable to maintain pedaling frequency \> 40 rpm, they achieved a respiratory exchange ratio of more than 1.0, or clinical criteria for test termination was observed. VO2max was measured and monitored with a breath-by-breath gas exchange system.
次要结局
- Trail Making Test(At baseline and after 4 months of intervention)
- Muscle Strength(At baseline and after 4 months of intervention)
- Cerebral Blood Flow Velocity (BFV)(At baseline and after 4 months of intervention)
研究者
Vera Novak
Associate Professor of Neurology, Director Safe Laboratory
Beth Israel Deaconess Medical Center