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Health BehaviorNCT01336309

Development of a Translational Tool to Study Yoga Therapy

An observational study of Health Behavior, run by University of Connecticut at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study comprises 4 phases designed to systematically develop and test a reliable, valid and useful quantitative measure of the components and dimensions of yoga; each phase builds on the previous phase. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Health Behavior
What is being tested?
Yoga Research Tool
How many people
1,832 participants
Where
1 siteUnited States
Study dates
Jan 2011to Aug 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Yoga teachers, students, and researchers.

Who may be able to join

  • Yoga teachers, students, and researchers

Who cannot join

  • Those who do not participate in regular (weekly) yoga practice

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Crystal Park

    Storrs, Connecticut, 06269

Other trials in United States

About this study

This study comprises 4 phases designed to systematically develop and test a reliable, valid and useful quantitative measure of the components and dimensions of yoga; each phase builds on the previous phase. Phase I aims to gain a comprehensive understanding of the relevant aspects of yoga therapy and develop a large pool of potential questionnaire items by conducting a thorough literature review and focus groups with yoga teachers and students. These data will be analyzed using rigorous qualitative methods to identify key conceptual dimensions associated with yoga interventions. Phase II will develop a prototypic questionnaire to assess yoga therapy by refining and honing information from Phase I and conducting cognitive interviews to further develop this instrument. Phase III will pilot test the measure in a field observation of yoga students and use factor analysis and item response theory to select the best items per dimension and to reduce the number of items in the measure. Phase IV will collect data on the new instrument and test the psychometric properties of the questionnaire (i.e., reliability and validity using data collected in Phases III and IV).

Read the 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.

Conditions
Health Behavior
Being tested
Yoga Research Tool
Keywords
Yoga
Medical subject headings
Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga Research ToolBehavioural

    We will be collecting data from a literature search, focus groups, cognitive interviews, and an online survey to build a measure for yoga researchers.

Study groups in NCT01336309
Study groupRoleWhat they receive
Focus GroupWe 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.
Receives: Behavioral: Yoga Research Tool
Cognitive InterviewsWe 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.
Receives: Behavioral: Yoga Research Tool
Survey Prototype AdministrationWe 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.
Receives: Behavioral: Yoga Research Tool
Reliability and Validity TestingWe 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.
Receives: Behavioral: Yoga Research Tool

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EPYQ Essential Properties of Yoga Questionnaire

    The EPYQ is the survey that is being developed for this study to assess the essential properties of a yoga class or intervention

    Measured: Post yoga class in Phase IV

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Cross-sectional
Enrolment
1,832 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01336309
Sponsor's protocol ID
IRB # H10-226
Other IDs
1R01AT006466-01
Status last verified
Aug 2016
First submitted
13 Apr 2011
Last updated
10 Aug 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Health Behavior, run by University of Connecticut at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EPYQ Essential Properties of Yoga Questionnaire (time frame: Post yoga class in Phase IV). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.

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