- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01336309
Development of a Translational Tool to Study Yoga Therapy
Study Overview
Detailed Description
The use of yoga for general health and wellness and for dealing with particular health conditions is increasing in the United States According to the National Health Interview Survey (NHIS) Alternative Medicine Supplement, the use of yoga increased significantly from 2002 to 2007 (NCCAM/Barnes, Bloom & Nahin, 2008), to 6.1% of the US population. In people dealing with health issues, the percent using yoga may be much higher (Birdee et al., 2008; NCCAM/Barnes et al., 2008). For example, in recent years, yoga has become a core complementary approach sought out by cancer patients and survivors of all cultural backgrounds in dramatically larger numbers (Mackenzie, Carlson, Munoz, & Speca, 2007).
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Connecticut
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Storrs, Connecticut, United States, 06269
- Crystal Park
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Yoga teachers, students, and researchers
Exclusion Criteria:
- Those who do not participate in regular (weekly) yoga practice
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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We will be collecting data from a literature search, focus groups, cognitive interviews, and an online survey to build a measure for yoga researchers.
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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.
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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.
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We will be collecting data from a literature search, focus groups, cognitive interviews, and an online survey to build a measure for yoga researchers.
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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.
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We will be collecting data from a literature search, focus groups, cognitive interviews, and an online survey to build a measure for yoga researchers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EPYQ Essential Properties of Yoga Questionnaire
Time Frame: Post yoga class in Phase IV
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The EPYQ is the survey that is being developed for this study to assess the essential properties of a yoga class or intervention
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Post yoga class in Phase IV
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Erik Groessl, PhD, University of California, San Diego
- Principal Investigator: Rani Elwy, PhD, Boston University
- Principal Investigator: Susan Eisen, PhD, Boston University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB # H10-226
- 1R01AT006466-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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