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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Yoga Research Tool | |
| 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. Receives: Behavioral: Yoga Research Tool | |
| 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. Receives: Behavioral: Yoga Research Tool | |
| 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. Receives: Behavioral: Yoga Research Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted15 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Crystal Park, University of Connecticut
- Investigators
- Erik Groessl, PhD, Principal investigator, University of California, San DiegoRani Elwy, PhD, Principal investigator, Boston UniversitySusan Eisen, PhD, Principal investigator, Boston University
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Translational Tool to Study Yoga Therapy
- ClinicalTrials.gov ID
- NCT01336309
- Acronym / sponsor ID
- IRB # H10-226
- Conditions
- Health Behavior
- Keywords
- Yoga
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,832 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jan 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Focus Group | – | Behavioral: Yoga Research ToolWe 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. |
| Cognitive Interviews | – | Behavioral: Yoga Research ToolWe 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. |
| Survey Prototype Administration | – | Behavioral: Yoga Research ToolWe 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. |
| Reliability and Validity Testing | – | Behavioral: Yoga Research ToolWe 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Yoga teachers, students, and researchers.
Key inclusion criteria (1 listed)
- Yoga teachers, students, and researchers
Key exclusion criteria (1 listed)
- Those who do not participate in regular (weekly) yoga practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga Research ToolWe will be collecting data from a literature search, focus groups, cognitive interviews, and an online survey to build a measure for yoga researchers. | Behavioural | Cognitive Interviews, Focus Group, Reliability and Validity Testing, Survey Prototype Administration |
Primary outcome
EPYQ Essential Properties of Yoga Questionnaire
Time frame: Post yoga class in Phase IV
The EPYQ is the survey that is being developed for this study to assess the essential properties of a yoga class or intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Groessl, PhD principal investigator
University of California, San Diego
Rani Elwy, PhD principal investigator
Boston University
Susan Eisen, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
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.