Development of a Translational Tool to Study Yoga Therapy
NCT ID: NCT01336309
Last Updated: 2016-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1832 participants
OBSERVATIONAL
2011-01-31
2016-08-31
Brief Summary
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Detailed Description
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Yoga interventions are being introduced for a variety of health conditions. Research evaluating these interventions remains inconclusive (NCCAM/Barnes et al., 2008) but preliminary results are promising. Many studies have reported evidence of superiority of yoga interventions relative to controls, although it is often difficult to determine the adequacy of the control condition. Reviewing the studies that compared yoga specifically to a physical exercise control condition, Ross and Thomas (2010) reported favorable findings for the impact of yoga on specific health conditions including cardiovascular disease (e.g., Raub, 2002), metabolic syndrome (e.g., Innes et al., 2005), diabetes (e.g., Upadhyay et al., 2008), cancer (see Bower et al., 2005) and anxiety (see Kirkwood et al., 2005). Similarly, a review of yoga interventions for chronic lifestyle-related diseases (Tekur et al., 2008) noted that yoga has been shown to be effective for treating osteoarthritis (Garfinkel et al., 1998), rheumatoid arthritis (Haslock et al., 1994), essential hypertension (Murugesan et al., 2000), bronchial asthma (Nagarathna et al., 1985; Vedanthan et al., 1998), irritable bowel syndrome (Taneja et al., 2004), diabetes (Singh et al., 2001), coronary artery disease (Manchanda et al., 2000), and depression (Woolery et al., 2004). Yoga has also been used in patients with chronic lower back pain (CLBP). Two randomized control trials on yoga for CLBP using Viniyoga (Sherman et al., 2005) and Iyengar yoga therapy (Williams et al., 2009) showed reduction in pain and functional disability relative to control groups. These studies contribute to the accumulating body of research evidence attesting to the positive health benefits of yoga. The recent NCCAM report indicates that, while promising, much more research evaluating these interventions is needed (NCCAM/Barnes et al., 2008). Currently, the content and substance of yoga remains a "black box" in that no studies have identified the effective ingredients of yoga. The proposed study will develop a tool to identify and quantify the components of yoga. The tool will thus allow researchers to link specific components of yoga to specific health outcomes such as pain, depression, functioning, etc.
Conditions
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Study Design
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CROSS_SECTIONAL
Study Groups
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Focus Group
We conducted three focus groups per site, at three sites, with around eight people each. These data were used to guide refinement and selection of the items we developed for Phase III data collection. We will administer the Yoga Research Tool.
Yoga Research Tool
We will be collecting data from a literature search, focus groups, cognitive interviews, and an online survey to build a measure for yoga researchers.
Cognitive Interviews
We conducted cognitive interviews at three different sites, with about ten in each group. These data were used to guide refinement and selection of the items we developed for Phase III data collection. We collected this data via a large, online survey and administered the Yoga Research Tool.
Yoga Research Tool
We will be collecting data from a literature search, focus groups, cognitive interviews, and an online survey to build a measure for yoga researchers.
Survey Prototype Administration
We administered a prototype of the study measure to a large group of yoga students, with about 450 total participants. These data were used to further inform the refinement and selection of items to be used in the final measure.
Yoga Research Tool
We will be collecting data from a literature search, focus groups, cognitive interviews, and an online survey to build a measure for yoga researchers.
Reliability and Validity Testing
We are conducting yoga classes at community partner facilities near each site, with about ten participants in each class. Participants at each class will complete the study measure and related questionnaires, in order to test the reliability and validity of the study measure.
Yoga Research Tool
We will be collecting data from a literature search, focus groups, cognitive interviews, and an online survey to build a measure for yoga researchers.
Interventions
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Yoga Research Tool
We will be collecting data from a literature search, focus groups, cognitive interviews, and an online survey to build a measure for yoga researchers.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
University of Connecticut
OTHER
Responsible Party
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Crystal Park
Professor
Principal Investigators
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Erik Groessl, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Rani Elwy, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston University
Susan Eisen, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston University
Locations
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Crystal Park
Storrs, Connecticut, United States
Countries
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Other Identifiers
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IRB # H10-226
Identifier Type: -
Identifier Source: org_study_id
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