NCT03435315终止不适用
Treadmill Exercise in Metabolic Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Recruitment Feasibility
研究概览
简要总结
The main purpose of this study is to better understand the effects of two types of treadmill exercise programs that include education and/or techniques that may be helpful for exercise among individuals with, or at risk for, metabolic syndrome.
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 (Participant)
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
- 否
入选标准
- •Referred by healthcare provider and given medical clearance for moderate-intensity exercise
- •Metabolic syndrome, defined as meeting three or more of the following criteria:
- •Obesity or overweight defined as BMI > 25
- •Impaired glycemia (fasting blood sugar of ≥ 100 [5.6 mmol/L] or glycated hemoglobin [A1C] of ≥ 5.7)
- •Increased blood pressure (130/85 mmHg or higher) or if you take medicine for high blood pressure
- •Increased fasting levels of triglycerides (≥ 150 or 1.7 mmol/L) or decreased fasting high-density lipoprotein (HDL) cholesterol (less than 40 mg/dL or 1 mmol/L for men or 50 mg/dL or 1.3 mmol/L for women) or if you take any medicines for dyslipidemia
- •Between the ages of 18-65
- •No regular physical activity (≥ 3 or more days per week) for the past 3 months
排除标准
- •Contraindications for treadmill exercise determined by their physician (e.g., cardiopulmonary limitations or diagnoses) or other inability to do treadmill exercise (e.g., musculoskeletal restrictions or severe balance impairment)
- •Confirmed diagnosis of coronary artery disease
- •Confirmed diagnosis of diabetes
- •Currently taking a beta blocker or calcium channel blocker medication
- •Uncontrolled and untreated hypertension, defined as a resting blood pressure of 150/90
- •Confirmed diagnosis of chronic obstructive pulmonary disease or other severe lung dysfunction that may interfere with exercise (e.g., severe asthma)
- •Self-reported psychotic disorder
- •Current practice of mindfulness mediation or mindful movement (e.g., yoga or tai chi), defined as regular daily practice or >2 classes or self-guided sessions per week in the past three months.
- •Non-English speaking
结局指标
主要结局
Recruitment Feasibility
时间窗: Through study completion, an average of 1 year
% willing to be randomized
Protocol Adherence
时间窗: Through study completion, an average of 1 year
% sessions attended
次要结局
- Affect(Week 0, week 3, post-intervention (after 6 week intervention))
- Anxiety Sensitivity(Week 0, week 3, post-intervention (after 6 week intervention))
- Physical Activity Acceptance(Week 0, week 3, post-intervention (after 6 week intervention))
- Exercise Barriers(Week 0, week 3, post-intervention (after 6 week intervention))
- Physical Activity(Week 0, week 3, post-intervention (after 6 week intervention))
- State Mindfulness(Weeks 1, 3, 6)
- Cardiopulmonary Dynamics(Weeks 1 and 6)
- Fatigue(Week 0, week 3, post-intervention (after 6 week intervention))
- Psychological Symptoms(Week 0, week 3, post-intervention (after 6 week intervention))
- Exercise Self-Efficacy(Week 0, week 3, post-intervention (after 6 week intervention))
- Global Health(Week 0, week 3, post-intervention (after 6 week intervention))
- Distress Tolerance(Week 0, week 3, post-intervention (after 6 week intervention))
- Trait Mindfulness(Week 0, week 3, post-intervention (after 6 week intervention))
- Discomfort Intolerance(Week 0, week 3, post-intervention (after 6 week intervention))
- Exercise Motivation(Week 0, week 3, post-intervention (after 6 week intervention))
- Interoceptive Awareness(Week 0, week 3, post-intervention (after 6 week intervention))
研究者
Gloria Y. Yeh
Associate Professor of Medicine
Beth Israel Deaconess Medical Center
研究点 (2)
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