Running Head: IT TAKES PRACTICE: THE SEARCH FOR THE RIGHT YOGA

Zane Muthamia It Takes Practice: The Search for the Right Yoga Intervention for Asthmatic Adults June 14, 2013 N204 Research Design and Critique

Running Head: IT TAKES PRACTICE: THE SEARCH FOR THE RIGHT YOGA Phase I: Validation Phase

Complimentary and alternative medicine interventions have gained considerable popularity in the United States as symptom relieving or curative alternatives to many chronic conditions in the last forty years. Asthma is a chronic pulmonary disease that in the same time period has seen a significant increase in prevalence worldwide. Identifying cost-effective, non-invasive, nonpharmacologic interventions for the treatment of asthma will greatly reduce the burden of care to our healthcare system and to society at large. Several studies have looked at utilizing yoga practice to improve both self-reported quality-of-life scores in asthma patients as well as improve clinical measurement scores, such as those obtained via pulmonary function tests (PFTs). Little research has been done on group-oriented yoga interventions that specifically focus on expiratory breathing techniques in the clinical-community setting. I based my paper on the following research articles: Kligler, B., Homel, P., Blank, A. E., Kenney, J., Levenson, H., & Merrell, W. (2011). Randomized trial of the effect of an integrative medicine approach to the management of asthma in adults on disease-related quality of life and pulmonary function. Altern Ther Health Med, 17(1), 10-15. Sabina, A. B., Williams, A. L., Wall, H. K., Bansal, S., Chupp, G., & Katz, D. L. (2005). Yoga intervention for adults with mild-to-moderate asthma: a pilot study. Ann Allergy Asthma Immunol, 94(5), 543-548. Saxena, T., & Saxena, M. (2009). The effect of various breathing exercises (pranayama) in patients with bronchial asthma of mild to moderate severity. Int J Yoga, 2(1), 22-25. doi: 10.4103/0973-6131.53838

Running Head: IT TAKES PRACTICE: THE SEARCH FOR THE RIGHT YOGA Kligler et al followed a prospective parallel group repeated measurement randomized design and examined whether or not there were synergistic effects when a multimodal intervention was used to treat chronic mild-to-moderate asthma in adults. The study has three components: nutritional manipulation and supplementation, yoga breathing, and journaling. The

outcome measurement tools utilized were the Asthma Quality of Life Questionnaire (AQLQ), the Medical Outcomes Study Short Form-12 (SF-12, version 2), and standardized Pulmonary Function Tests (PFTs). All instruments had been validated in numerous prior studies. Measures were obtained at baseline, after treatment protocol was administered and at 3 and 6-month intervals, with the exception of the PFTs, which were not conducted at 3 months. With regards to the yoga intervention branch of the study, participants attended two classes in yoga and pranayama breathing techniques that were chosen specifically to open the chest and facilitate breathing. Certified instructors had experience in the pulmonary rehabilitation setting, and participants were provided with a CD for home study and practice. Other important elements of the set up of the study that relate to my clinical problem of interest include that the cost of the intervention ($260 per participant), including all nutritional supplements, were covered by the study, and roughly 20% of controls and 13% of treatment participants dropped out of the study (both groups started with 77 participants, mostly women with a mean age of ~44, and had no significant differences regarding their characteristics at baseline). With regards to study results, the treatment group experienced a significantly greater improvement in quality of life (QOL) relative to controls as measured by both the AQLQ and SF12. Neither group showed statistically relevant changes regarding PFTs.

Running Head: IT TAKES PRACTICE: THE SEARCH FOR THE RIGHT YOGA The researchers admit that the study was limited by the fact that the benefits gained by the participants couldnt be attributed to any specific branch of the study, due to the fact that it was multi-modal by design. Sabina et al followed a randomized, controlled, double-masked clinical trial to determine the

effectiveness and feasibility of a yoga and breath work intervention for improving QOL and clinical indices in adults with mild-to-moderate asthma. Sixty-two participants were randomized to intervention and control groups, and 45 participants finished the study. The intervention group participated in twice-weekly 90-minute iyengar yoga sessions for four weeks, and were given printed materials and audiocassettes and encouraged to practice at home. The control group participated in a sham intervention of basic muscle stretching exercises and were also given similar materials and encouraged to practice at home. The mean age of participants was 51 years, they were mostly women, and the groups did not significantly differ regarding other baseline demographic characteristics. The primary outcome measures were the frequency of rescue inhaler use, QOL as measured by the Mini Asthma Quality of Life Questionnaire (MiniAQLQ), and specific clinical scores as measured by PFTs. Outcome measures were evaluated at 4, 8, 12, and 16 weeks. QOL did not differ significantly between treatment groups at any point, but the yoga group had a significant increase in effect at 16 weeks regarding overall QOL. Neither treatment proved effective on the frequency of inhaler use. There were significant improvements in both groups regarding PFT measured scores and an improvement in morning asthma symptoms, yet no meaningful difference between the intervention and sham group. Other important qualities of this study that influence the design my pilot study are that the intervention and sham intervention might be considered too similar, hence the measured results were also similar; that all language (e.g., all Sanskrit words) indicating that the intervention being

Running Head: IT TAKES PRACTICE: THE SEARCH FOR THE RIGHT YOGA measured was yoga were removed from the teaching, and instead what was being taught was referred to as complimentary care body conditioning; that this yoga intervention did not particularly focus on yoga breathing, and that this study experienced numerous recruitment challenges and attrition problems, a result of which is an underpowered study. A significant

finding of the study was that incorporating yoga into the lifestyle of a person with asthma does not happen easily. Cost, time commitment, and the proposed schedule of the intervention were all sited as contributing to the challenges the study encountered. The final study I examined was conducted by Saxena & Saxena in India to measure whether or not breathing exercises (pranayama) would improve symptoms (viz., cough, wheezing, and dyspnea), FEV1 scores and Peak Expiratory Flow Rate (PEFR) scores in patients with mild-tomoderate asthma. Normalized technique was used and all tests were performed at baseline and after treatment protocol. Fifty patients were selected and numbered, the even numbers being assigned to the treatment group and the odds to the control group. For 12 weeks, the treatment group practiced breathing exercises for 20 minutes twice daily, and the control group meditated for the same. After 12 weeks, there was a significant reduction in all clinical measures by the treatment group. Importantly, the cases had to have an interest in yoga and a minimum of six months experience with yoga practices. The participants also were alleged to have no history of being on a regular asthma medication regimen, and were advised to discontinue use of medications if taking them. The researchers concluded that both forceful and prolonged expiratory exercises were beneficial to improving asthma symptoms. The mean age of the participants was considerably younger than that of the American cohorts (29 years old) and participants were virtually equal in number with regards

Running Head: IT TAKES PRACTICE: THE SEARCH FOR THE RIGHT YOGA to gender. This study did not look into QOL assessment and only measured clinical pulmonary scores and symptoms.

In reviewing the results of all three studies, a possible solution to improving clinical measures of lung function may lie in focusing the yoga teaching specifically on breathing techniques. Performing the practices frequently and narrowing the focus even more on practicing expiratory breathing exercises also appears to be beneficial to asthma sufferers. The Sabina et al study showed improvements in forced expiratory volume (FEV1) scores and morning asthma symptoms in both groups, yet this was the only study with an active, sham control (which points to regular physical exercise in general as potentially causal in the improved outcomes). Factors that improved compliance and completion of the studies (or point to reasons for attrition rates) include covering the costs of the intervention and whether or not community support/a sense of community between participants was encouraged. One unnamed but surely distinct advantage that the Saxena & Saxena study might have had on its American counterparts was relative cultural homogeneity and probably an underlying, unifying belief in overall health benefits conferred by yoga practice, further stressing the potential importance of community in success rates. QOL assessments were only performed by the Kligler et al and Sabina et al studies, and the results were not congruous, one showing marked improvement in scores and the other showing no difference between the test and control groups. Phase II: Comparative Evaluation Phase Fit of Setting The mixed nature of the findings of the studies suggests there is reason for being optimistic that creating a pilot study which borrows what appears to be the most beneficial and effective elements from each and offering them in a primary care or clinical community setting might produce improved clinical PFT scores in asthmatic adults. The QOL scores, although arguably important,

Running Head: IT TAKES PRACTICE: THE SEARCH FOR THE RIGHT YOGA will not be a focus of my pilot study; I feel that the question of whether or not a participants

quality of life improves when symptom and PFT score values improve is somewhat obvious, and I would rather spend study resources on the strictly more physiological measures.

Substantiating Evaluation The results of the three studies that I have evaluated are not consistent, yet as I have discussed elsewhere, the studies varied substantially with regards to design elements and choices, and the details of the yoga intervention offered. All of them concluded that further studies into the benefits of yoga to asthmatic adults were warranted. The Kligler et al study covered the financial costs of the intervention; the Saxena & Saxena study didnt discuss cost, whereas the Sabina et al study listed cost as a possible factor responsible for high drop out rates. Focusing the yoga intervention on breathing techniques specifically as the Saxena & Saxena study did, and encouraging frequent practice appears very important. Finally, the community support and interest in yoga that was stressed in the Kligler et al participants and in the Saxena & Saxena study conducted in India will be incorporated in the pilot study. Basis for Practice I would like to explore whether an intensive intervention of teaching yogic breathing techniques that focus on expiratory breathing will improve PFT scores in asthmatic adults. The intervention will be offered in primary care settings that have ties to an asthma clinical community center, such as UCLAs Asthma and Cough Center1 (the Center) or Collaborative

The Asthma and Cough Center is an integrated, multidisciplinary regional referral center for the diagnosis and management of adult asthma and coughThe center offers a wide range of diagno stic and educational services including multidisciplinary consultation and continuing care, patient education, inhalation challenge testing, industrial hygiene consultation, second opinion consultation, and rehabilitation services (The UCLA Asthma and Cough Center, 2013).

Running Head: IT TAKES PRACTICE: THE SEARCH FOR THE RIGHT YOGA Centers for Integrative Medicine2 (CCIM). Utilizing the Rosswurm and Larabee model, I will encourage primary care providers associated with the Center/CCIM, as well as Center/CCIM administrators, to assess the need for change/the need for implementing an intervention of this type. Data will be collected to establish what types of non-pharmacological asthma treatments

have been offered to date, and comparisons with other similar asthma clinical community centers will be made. After baseline data has been collected, a review of current practices will be conducted to ascertain whether the Center/CCIM has the human and physical resources to implement the intervention. Outcome measures currently in use will be identified, such as PFT scores and symptom measurement tools. The review of literature that I have conducted thus far shows that there is a warranted basis for exploring offering a no- or low-cost, nonpharmacological, community centered intervention and for recruiting patients in the primary care setting. After the study is concluded, we will evaluate whether or not to adopt, adapt, or reject the intervention. In the event that it is adopted, communicating the outcome to community stakeholders, including primary care providers, patients and their families, and insurance coverage providers will be necessary. Finally, integrating the intervention into standards of practice and continuing to monitor the process and outcomes of the new practice will be conducted on an on-going basis.

Feasibility The true benefit of this pilot design lies in the fact that it will provide a lot of support and instruction that is tailored to addressing breathing techniques with no added out of pocket costs for
2

CCIM defines integrative medicine as the practice of medicine that reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, healthcare professionals and disciplines to achieve optimal health and healing (UCLA Collaborative Centers for Integrative Medicine, 2013)

Running Head: IT TAKES PRACTICE: THE SEARCH FOR THE RIGHT YOGA participants. An asthmatic adult can enroll in yoga classes in the community in most cities in the US, but finding classes that focus on expiratory breathing techniques, and that are offered at the intensity that I will propose, would probably be hard to find, and be costly to boot. Moreover,

having an interdisciplinary team in place that concerns itself with this specific population, and the promise to participants of interacting with people with the same types of problems, might improve compliance and lower attrition rates. Some disadvantages might include finding a pool of primary healthcare providers that would be willing to recommend a non-Western intervention for asthma management, although this stumbling block might not be as serious as it would have been even ten years ago, due to the fact that yoga practice has been familiarized to the masses by popular culture. Along the same lines, some patients might not be receptive to the idea of trying an intervention like yoga, and might have misconceptions about its difficulty, or think that they do not fit the mold of the type of person that practices yoga. More will be said on this point later in this paper.

Phase III: Decision-Making Phase The pilot study seeks to show improvement in pulmonary function test (PFT) scores after participation in an intensive yoga breathing intervention by adults with mild-to-moderate asthma. Primary care providers will refer patients for the pilot study to the Center/CCIM, where the intervention will be offered. Participants will consist of adults between the ages of 18-80 years old. Exclusion criteria will looser than in the studies I reviewed, based primarily on the patient having a prohibitive co-morbidity that might make participation a risk factor for more serious morbidity/mortality. The study aims for having 200-300 participants, and the final sample size will be determined by a power analysis. The study will follow a prospective parallel group repeated measurement randomized design, like that utilized by Kligler et al. Participants will attend yogic

Running Head: IT TAKES PRACTICE: THE SEARCH FOR THE RIGHT YOGA

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expiratory breathing classes two times a week for one month, and then practice the technique for a minimum of 20 minutes daily for an additional three months. Participation in supplemental classes about yogic philosophy and health behavior modification will be offered as well. Participants costs will be covered by the study to encourage participation by individuals from varying socio-economic backgrounds. The process and outcome measures will be evaluated every week for the intense initial intervention period, and then every 4 weeks, for a total of four months. The groups that must accept and implement the intervention include patients and their families, primary care providers, and the Center/CCIM administrators and staff. The motivation for either participating directly or supporting participants in the study is that incorporating the breathing techniques might significantly improve patient PFT scores, which in turn would mean participants would enjoy improved and easier breathing. My hope is that by offering the intervention in a asthma-related clinical community setting, the healthcare providers will inherently be more motivated due to their personal commitment to the intervention and disease. Potential barriers to change might include the initial time spent in participating in the intensive segment of the intervention, or synchronizing class schedules to fit patient availability. One possible solution is to offer the intervention at a variety of times throughout the week, allowing for patients to have flexibility with changing their proposed attendance schedule, and allowing for class size to be relatively small (as few as ten members). There are also numerous scheduling software programs that can be implemented by the administrative staff to encourage participants to schedule themselves using the Internet that are simple and straight-forward to use. Another potential barrier that I mentioned elsewhere is that patients and their families might have misconceptions about yoga, such as thinking that practicing yoga requires certain types of religious beliefs or physiological strengths. Teaching participants and their families about yoga in

Running Head: IT TAKES PRACTICE: THE SEARCH FOR THE RIGHT YOGA general should be offered throughout the intervention via various methods (in-class, online, via social networking sites) to overcome this perceived barrier to change.

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Finally, I believe that expert interdisciplinary teams consisting of program administrators, yoga breathing technique instructors, supportive primary care providers, and perhaps even therapists or yoga philosophy educators will be able to offer patients and their families information and education covering physiological, behavioral, and even spiritual support as desired. Communication of Findings The administration of the Center/CCIM will be informed of the outcome of the pilot study in a meeting with study designers and key staff members. The plan, implementation, results, and cost of the intervention will be presented in a report and demonstrated in a PowerPoint presentation. Staff nurses working in other parts of the Center/CCIM, as well as the primary care providers that made the referrals, will be informed via the Center/CCIMs weekly e-newsletter. Bulletins will be posted in personnel areas so that ancillary health care personnel are informed of study outcomes. Large posters and fliers will be placed on the walls or appropriate message boards in the general use areas of and around the Center/CCIM for the public to learn about the outcomes of the pilot study. Finally, social media resources, such as Facebook or Twitter, will be utilized to spread the word about the pilot programs outcomes to interested stakeholders elsewhere in the world.

Running Head: IT TAKES PRACTICE: THE SEARCH FOR THE RIGHT YOGA References Kligler, B., Homel, P., Blank, A. E., Kenney, J., Levenson, H., & Merrell, W. (2011).

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Randomized trial of the effect of an integrative medicine approach to the management of asthma in adults on disease-related quality of life and pulmonary function. Altern Ther Health Med, 17(1), 10-15. Sabina, A. B., Williams, A. L., Wall, H. K., Bansal, S., Chupp, G., & Katz, D. L. (2005). Yoga intervention for adults with mild-to-moderate asthma: a pilot study. Ann Allergy Asthma Immunol, 94(5), 543-548. Saxena, T., & Saxena, M. (2009). The effect of various breathing exercises (pranayama) in patients with bronchial asthma of mild to moderate severity. Int J Yoga, 2(1), 22-25. doi: 10.4103/0973-6131.53838 UCLA Asthma and Cough Center. (2013). Retrieved from: http://www.uclahealth.org/body.cfm?id=453&action=detail&limit_department=15&limit _division=1090&limit_program=5016&CFID=78969548&CFTOKEN=63789022 UCLA Collaborative Centers for Integrative Medicine. (2013). Retrieved from: http://ccim.med.ucla.edu/?page_id=2

Running Head: IT TAKES PRACTICE: THE SEARCH FOR THE RIGHT YOGA

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CITATION

PURPOSE

SAMPLE/ SETTING This was a randomized trial with a parallel group repeated measurement design. Participants were recruited from the greater New York City area over 18 months. 77 control patients and 77 treatment patients were randomized using block randomization.

METHODS

RESULTS

Kligler, B., Homel, P., Blank, A. E., Kenney, J., Levenson, H., & Merrell, W. (2011). Randomized trial of the effect of an integrative medicine approach to the management of asthma in adults on disease-related quality of life and pulmonary function. Altern Ther Health Med, 17(1), 10-15.

Prospective study to test the effectiveness of a multimodal, lowcost intervention comprised of journaling instruction, yoga breathing, and nutritional manipulation and supplementati on in adults with asthma. To determine the effectiveness and feasibility of a yoga and breath work intervention for improving clinical indices and quality of life in adults with mild-tomoderate asthma.

Sabina, A. B., Williams, A. L., Wall, H. K., Bansal, S., Chupp, G., & Katz, D. L. (2005). Yoga intervention for adults with mildto-moderate asthma: a pilot study. Ann Allergy Asthma Immunol, 94(5), 543-548.

A randomized, controlled, doublemasked clinical trial was conducted over 2 years. 62 participants enrolled, 45 were retained. Random assignment was made to either a 4week yoga intervention that included postures and breath work or an active control group consisting of stretching exercises.

The intervention consisted of a 6 weekly 1-1.5 hr. meetings in a group setting. 2 nutritional treatment sessions, 2 yoga and pranayama breathing technique classes, a guided journaling session and a final informal Q&A. AQLQ, SF-12 and standardized PFT scores measured. Outcome measures were evaluated at 4, 8, 12, and 16 weeks and included the Mini Asthma Quality of Life Questionnaire, rescue inhaler use, spirometry, symptom diaries, and health care utilization.

Overall improvement s in QOL in adults with asthma over 6 month period. PFTs did not show statistically significant changes over time in either group.

DISCUSSION & LIMITATIONS Significant improvements to QOL scores in intervention group. No blinding and the multimodal nature of the study make attributing improvements to yoga in particular impossible. Indicates need for more studies on the subject.

Intention to treat analysis was performed. Significant within-group differences in FEV1 scores and morning symptom scores were seen in both groups. No significant differences between groups seen in any outcome measures.

Yoga intervention conferred no noteworthy benefit. The intervention and sham intervention may have been too similar to one another. Compliance problems seen in both groups, as well as high attrition rates.

Running Head: IT TAKES PRACTICE: THE SEARCH FOR THE RIGHT YOGA Saxena, T., Saxena, M. (2009). The effect of various breathing exercises (pranayama) in patients with bronchial asthma of mild to moderate severity. Int J Yoga, 2(1), 22-25. doi: 10.4103/09736131.53838 A randomized control study conducted in Ajmer, India to study the effect of yogic breathing exercises in adults with mild-tomoderate asthma. 25 participants and 25 controls were randomized to two groups. The test group practiced breathing exercises for 20 minutes twice daily and the controls meditated for 20 minutes twice daily for 12 weeks. Clinical outcomes were measured via FEV1 and PEFR scores were compared at baseline and after the treatment phase. Symptoms scores for coughing, wheezing, and dyspnea were calculated using the Mantel Haensal X2 formula. There was a significant reduction in FEV1 and PEFR scores in the treatment group as compared to the meditation group as well as in symptoms scores.

14 Expiratory exercises that focused on force and prolonged expiration were shown to be especially beneficial. Although study participants allegedly had no history of using medication for asthma, all were instructed to stop before participating in the study; it is unclear how this was enforced or monitored.