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The Move Well Study (MW)

2021年6月4日 更新者:Arizona State University

Effects of Meditative Movement on Body Composition in Midlife Women

This study will explore the effects of meditative movement on body composition in a group of 60 midlife women. Women will participate in 30-minute meditative movement (MM) classes for an eight-week period. Participants will be encouraged to practice MM at home for at least 30 minutes most days per week. Participants will be asked to complete a log of their time spent doing meditative movement outside of classes.

研究概览

详细说明

A growing body of published evidence indicates that meditative movement (MM) practices may be helpful for body composition improvement. Less strenuous forms of exercise that include a focus on the breath and meditative state (i.e., "meditative movement" such as Yoga, Qigong, or Tai Chi) may be easier to adopt for unfit, sedentary, overweight or obese women, which characterizes a large percentage of the general population. Despite this preliminary evidence, no studies have proposed a model for how or why weight loss might occur in MM interventions where the goals are not designated as weight loss, nutritional counseling is not included, and energy expenditure is not at the level assumed to be required to achieve weight loss. The proposed intervention is designed to refine and gather preliminary evidence for a novel "mindful-body-wisdom" model of intervening on improving body composition and to examine the contribution of model factors (psychological and behavioral) of how such a non-diet/non-vigorous exercise intervention might work, in 60 midlife women.

TCE is a simple TC/QG form that was developed by Dr. Roger Jahnke and developed into a standardized research intervention protocol by a team of researchers. It has been used in several prior projects and one recently completed NIH/NCCAM-funded randomized controlled trial (RCT) with breast cancer survivors showing reduction in fatigue and depression, and improved sleep and physical function.

研究类型

介入性

注册 (实际的)

52

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

    • Arizona
      • Phoenix、Arizona、美国、85004
        • Arizona State University Downtown Campus

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

45年 至 75年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Female
  • 45-75 years of age
  • Ability to participate in low intensity activity

Exclusion Criteria:

  • Women who are unable to stand for 10-minute segments (e.g., wheelchair or walker bound and too weak)
  • Women who are unable to walk

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:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Meditative Movement Intervention
Participants will complete the following components of baseline (T1) data collection: demographics, biometric measurements, a heart rate variability assessment, and questionnaires. Participants will be asked to provide six saliva samples via passive drool to measure cortisol levels. Participants will be assigned into hour-long meditative movement (MM) classes for eight weeks total. Participants will be asked to practice their MM skills at home for at least 30 minutes most days per week. The study will distribute hard-copy movement manuals and DVD instruction videos for guidance. Participants will be asked to provide a log of all dates and lengths of their at-home practice. After the eighth class, participants will return for post-intervention (T2) data collection, consisting of biometric measurements, a heart rate variability assessment, and questionnaires. Participants will provide six more saliva samples via passive drool method.
Intervention will be taught by a certified Tai Chi Easy (TCE) group practice leader. The TCE movements will be repeated in differing sequences and time-frames during the course of the study. The variety and combination of the exercises will begin easy and progress to more advanced movements and/or intensities as the study progresses and participants become more experienced and comfortable with the routine. Participants spend one hour in class each week for a total of eight weeks.
其他名称:
  • Tai Chi Easy (TCE)

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
Body Fat Percentage
大体时间:8 weeks
Body fat percentage will be measured using Bioelectric Impedance Analysis (BIA) via the Tanita monitor. Score range= 0% to 100%. A higher score indicates a higher body fat percentage.
8 weeks
Emotional Eating
大体时间:8 weeks
Emotional eating will be measured using the Three Factor Eating Questionnaire (TFEQ) (21 items, 4-point Likert scale with response options 1 through 4 for items 1 through 17, response options 1 through 8 for item 18). Score range= 18 to 76. Emotional eating sub-score is calculated by combining six items of the TFEQ. A higher score indicates greater emotional eating.
8 weeks
Sleep Quality
大体时间:8 weeks
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) (10 items, 4-point Likert scale; 0= positive extreme of scale, 3= negative extreme of scale). Score range= 0 to 21. A higher score indicates worse sleep quality.
8 weeks

次要结果测量

结果测量
措施说明
大体时间
Perceived Stress Scale-10
大体时间:8 weeks
self-report measure of perceived stress, 10-items, Likert scale
8 weeks
Self-Compassion Scale (SCS)
大体时间:8 weeks
self-report measure of self-compassion as measured (26 items) by self-kindness, common humanity, non-judgment
8 weeks
Body Awareness Questionnaire (BAQ)
大体时间:8 weeks
self-report measure of experienced body awareness/iteroception, 18-items, Likert-scale
8 weeks
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
大体时间:8 weeks
self-report measure of mindfulness, Likert-scale, 9-items
8 weeks

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)

2017年3月27日

初级完成 (实际的)

2017年12月14日

研究完成 (实际的)

2017年12月14日

研究注册日期

首次提交

2019年8月13日

首先提交符合 QC 标准的

2019年8月26日

首次发布 (实际的)

2019年8月28日

研究记录更新

最后更新发布 (实际的)

2021年6月8日

上次提交的符合 QC 标准的更新

2021年6月4日

最后验证

2021年6月1日

更多信息

与本研究相关的术语

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.

Meditative Movement的临床试验

3
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