此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Treadmill Exercise in Metabolic Syndrome

2022年5月20日 更新者:Gloria Y. Yeh、Beth Israel Deaconess Medical Center
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.

研究概览

研究类型

介入性

注册 (实际的)

12

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • BIDMC

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Referred by healthcare provider and given medical clearance for moderate-intensity exercise
  2. 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
  3. Between the ages of 18-65
  4. No regular physical activity (≥ 3 or more days per week) for the past 3 months

Exclusion Criteria:

  1. 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)
  2. Confirmed diagnosis of coronary artery disease
  3. Confirmed diagnosis of diabetes
  4. Currently taking a beta blocker or calcium channel blocker medication
  5. Uncontrolled and untreated hypertension, defined as a resting blood pressure of 150/90
  6. Confirmed diagnosis of chronic obstructive pulmonary disease or other severe lung dysfunction that may interfere with exercise (e.g., severe asthma)
  7. Self-reported psychotic disorder
  8. 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.
  9. Non-English speaking

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:跑步机运动
12-session, 6-week traditional treadmill exercise program
实验性的:Treadmill exercise with behavioral techniques
12-session, 6-week treadmill exercise program utilizing behavioral techniques while walking

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Recruitment Feasibility
大体时间:Through study completion, an average of 1 year
% willing to be randomized
Through study completion, an average of 1 year
Protocol Adherence
大体时间:Through study completion, an average of 1 year
% sessions attended
Through study completion, an average of 1 year

次要结果测量

结果测量
措施说明
大体时间
Cardiopulmonary Dynamics
大体时间:Weeks 1 and 6
CardioPulmonary Exercise Testing (standard metabolic cart)
Weeks 1 and 6
Fatigue
大体时间:Week 0, week 3, post-intervention (after 6 week intervention)
Fatigue Severity Scale-7; total score range: 7-49, higher scores = greater fatigue severity
Week 0, week 3, post-intervention (after 6 week intervention)
Global Health
大体时间:Week 0, week 3, post-intervention (after 6 week intervention)
PROMIS Global Health-10; Global physical health total score range: 4-20, higher scores = better global physical health
Week 0, week 3, post-intervention (after 6 week intervention)
Psychological Symptoms
大体时间:Week 0, week 3, post-intervention (after 6 week intervention)
Depression Anxiety and Stress Scale-21; Depression total score range: 0-21, higher scores = greater depressive symptoms
Week 0, week 3, post-intervention (after 6 week intervention)
Affect
大体时间:Week 0, week 3, post-intervention (after 6 week intervention)
Positive and Negative Affect Schedule; 2 subscales; each with score range 10-50, higher = greater positive or negative affect
Week 0, week 3, post-intervention (after 6 week intervention)
Anxiety Sensitivity
大体时间:Week 0, week 3, post-intervention (after 6 week intervention)
Anxiety Sensitivity Index-3; Total score range: 0-72, higher scores = higher levels of anxiety sensitivity
Week 0, week 3, post-intervention (after 6 week intervention)
Distress Tolerance
大体时间:Week 0, week 3, post-intervention (after 6 week intervention)
Distress Tolerance Scale; total score range: 15-75, higher scores = higher levels of distress tolerance
Week 0, week 3, post-intervention (after 6 week intervention)
Discomfort Intolerance
大体时间:Week 0, week 3, post-intervention (after 6 week intervention)
Discomfort Intolerance Scale-Revised; total score range: 0-126, higher scores = higher levels of discomfort intolerance
Week 0, week 3, post-intervention (after 6 week intervention)
Physical Activity Acceptance
大体时间:Week 0, week 3, post-intervention (after 6 week intervention)
Physical Activity Acceptance Questionnaire; total score range: 10-70, higher scores = greater physical activity acceptance
Week 0, week 3, post-intervention (after 6 week intervention)
Exercise Self-Efficacy
大体时间:Week 0, week 3, post-intervention (after 6 week intervention)
Multidimensional Self-Efficacy Scale; total score range: 0-90, higher scores = higher levels of exercise self-efficacy
Week 0, week 3, post-intervention (after 6 week intervention)
Exercise Motivation
大体时间:Week 0, week 3, post-intervention (after 6 week intervention)
Behavioral Regulation towards Exercise Questionnaire-2; 5 subscales, each with score range: 0-16, higher scores = higher levels of regulation
Week 0, week 3, post-intervention (after 6 week intervention)
Exercise Barriers
大体时间:Week 0, week 3, post-intervention (after 6 week intervention)
Exercise Benefits and Barriers Scale; 2 subscales; Exercise benefits subscale score range: 29-116, higher scores = higher perceived benefit from exercise; Exercise barriers subscale score range: 14-56, higher scores = higher perceived barriers to exercise
Week 0, week 3, post-intervention (after 6 week intervention)
Physical Activity
大体时间:Week 0, week 3, post-intervention (after 6 week intervention)
Godin Leisure Time Exercise Questionnaire; open-ended responses, higher scores = greater activity time
Week 0, week 3, post-intervention (after 6 week intervention)
Trait Mindfulness
大体时间:Week 0, week 3, post-intervention (after 6 week intervention)
Five Facet Mindfulness Questionnaire; 5 subscales; Observe subscale score range: 8-40, higher scores = greater observing skills; Describe subscale score range: 8-40, higher scores = greater describing skills; Acting with Awareness subscale score range: 8-40, higher scores = greater awareness skills; Nonjudgment subscale score range: 8-40, higher scores = greater nonjudgment skills; Nonreactivity subscale score range: 7-35, higher scores = greater nonreactivity skills
Week 0, week 3, post-intervention (after 6 week intervention)
State Mindfulness
大体时间:Weeks 1, 3, 6
State Mindfulness Scale for Physical Activity; 2 subscales, each with score range: 0-24, higher scores = higher levels of mindfulness
Weeks 1, 3, 6
Interoceptive Awareness
大体时间:Week 0, week 3, post-intervention (after 6 week intervention)
Multidimensional Assessment of Interoceptive Awareness; 8 subscales, each with score ranges: 0-5, higher scores = better
Week 0, week 3, post-intervention (after 6 week intervention)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年1月9日

初级完成 (实际的)

2021年7月7日

研究完成 (实际的)

2021年10月20日

研究注册日期

首次提交

2018年1月23日

首先提交符合 QC 标准的

2018年2月9日

首次发布 (实际的)

2018年2月19日

研究记录更新

最后更新发布 (实际的)

2022年5月26日

上次提交的符合 QC 标准的更新

2022年5月20日

最后验证

2022年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅