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  Volume 1, Issue 3-2008
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Philanthropic Gift to Support ICAM "Yoga for MS" Research Project

by Susan Gould Fogerite, PhD, Director of Research, ICAM, Assoc. Professor Primary Care and Clinical Lab Sciences, SHRP, UMDNJ

 

Members of the yoga class ICAM recently received a generous gift of $10,000 to support a seed project to design and develop an integrated yoga program for individuals with Multiple Sclerosis (MS) that will be tested in a clinical trial. We are very grateful to Hugh Evans, MD, of New Jersey Medical School, for this generous donation made to the Musical Moments for MS event, which came through the Foundation of UMDNJ. Substantial work has been done on this project already, including preliminary design of the clinical trial and a draft proposal for funding. This gift will help support further research of the literature on both yoga and MS, design of the detailed clinical trial intervention and budget, and a comprehensive proposal for review by funding agencies, philanthropic individuals and groups, and the UMDNJ Institutional Review Board. In addition, to help insure appropriate trial design and successful recruiting, a survey of the local MS community will be developed and administered in association with the local New Jersey MS Society. This survey will determine interest in and experience with yoga, need for transportation, disability levels, optimal timing for classes, and various demographic variables.

Goals and Outcomes

The pilot clinical trial that will be developed through this work is currently entitled “The Effect

of Kundalini Yoga on the Quality Of Life and Physical Function of People with Multiple Sclerosis” . Our long term goal is to reduce suffering and increase the physical and mental well-being of people with multiple sclerosis. Our current primary objectives are to develop a yoga program specifically designed to help individuals with MS, and to test its efficacy in a scientifically rigorous, randomized controlled clinical trial. The primary outcome to be measured in this trial is effect on Quality of Life, (QOL), with secondary outcomes of changes in disability, pain, fatigue, depression, strength, flexibility, balance, and selected immune and neurological functions. The results of this study will clarify the potential of yoga to improve the quality of life and physical functioning of people with MS, and begin to look at biological parameters that may be associated with these changes. It will also provide a well defined yoga intervention that can be replicated in other locations. Positive results from this pilot trial will support future applications for funding for larger more definitive yoga trials.

Background and Rationale

MS is an autoimmune disease with an estimated prevalence of between 400,000 and 500,000 people in the United States and 2.7 million worldwide. Quality of Life (QOL) is known to be impaired in those with MS due to multiple factors, including physical disability, MS-associated fatigue, and pain. Weakness, spasticity (muscle stiffness or contraction), fatigue, ataxia (difficulty moving) and sensory loss, can lead to significant balance and mobility loss, with increased risk of falls. The practice of yoga has been shown to improve balance, coordination, strength, and flexibility. Depression, anxiety, and decreased cognitive function are also common challenges faced by people with MS. Yogic breathing practices, meditation, and postures have been shown to decrease anxiety and depression, and increase subjective well-being, as well as cognitive function, in healthy populations and in people with a number of chronic diseases. The results of the one randomized clinical trial of yoga for MS which has been published, case studies, and the experiences of many people, indicate that yoga is helpful for people with MS. However, there is a strong need for further research on yoga and MS to develop optimized yoga interventions, to broaden and deepen the scientific evidence for efficacy, and to move toward greater understanding of the mechanisms of action.

 

Study Team Experience

This team is uniquely suited to design and carry out a clinical trial of yoga for MS. Susan Gould-Fogerite, Ph.D.(yours truly), the Principal Investigator, is Director o f Rese arch for the Institute for  Complementary and Alternative Medicine  at the University of Medicine and Dentistry of New Jersey, (ICAM, UMDNJ).  I've been teaching, designing and supervising basic and pre-clinical science in microbiology and immunology for over 20 years in academia and industry. I'm also a teacher of yoga and meditation in the Himalayan Tradition. In recent years my major research focus has been on clinical research and the science of mind/body medicine. Three other highly experienced doctors are the co-investigators. Rene David Alkalay, D.D., Ph.D., N.D. has studied Kundalini, Kriya, and Tantra yoga with a number of yoga masters, and has been teaching yoga for nearly 30 years. He is also a certified exercise therapist and has significant experience in designing yoga interventions for people with disabilities, including MS. Dr. Alkalay is the founder and Director of the Tree of Life Yoga and Wellness Center , in Forest Hills , NY , where a “yoga for MS” class that he designed and supervises has been meeting weekly for more than a year. Rachel Oliker, M.D., after completing her undergraduate work at Stanford and medical school at SUNY Stony Brook, was diagnosed with MS during residency training in Rehabilitation Medicine at NY-Presbyterian Medical Center . Although her worsening medical condition made it necessary to leave that training program, she has since experienced significant improvement in her health. A major factor that she feels has lead to this improvement is her practice of yoga. Her personal experiences with MS and her medical training have inspired Dr. Oliker to dedicate her time and effort to developing research studies aimed at alleviating the challenges faced by the MS community. Adam Perlman, M.D., MPH, Executive Director of ICAM at UMDNJ is also the founder and Director of the Siegler Center for Integrative Medicine at Saint Barnabas Medical Center. In his many years as a Board Certified internist practicing integrative medicine, he has cared for many people with MS and other chronic diseases, utilizing allopathic and complementary and alternative medicine modalities. Ms. Crystal Jones of ICAM, Master in Public Administration, and Ms. Mariella Silva, licensed massage therapist and student in the ICAM Integrative Health and Wellness track of the SHRP Masters in Health Sciences program, are also helping with research and preparations for the trial. Many thanks to Marie Saimbert , MLS, Rph, RN, BSN of UMDNJ's George Smith Library for

her help and guidance in literature review and information management also.

Clinical Trial

The yoga program we are developing will seek to maximally engage the power of the mind body connection in healing. The yoga intervention will be Kundalini and Hatha Yoga, ffocusing on not only physical yoga poses, but also breathing exercises, meditation, chanting, silent prayer, guided imagery (visualizations), and relaxation.Research on the individual components suggests that this combination will support improved health and strength in body and mind. Yoga postures will be modified according to the capabilities of each student. Adults with MS who meet inclusion criteria will be randomly assigned to the yoga program or a wait list control group. Persons assigned to the wait list group will participate in the next session of the yoga program (several months later). We are currently designing the details of the yoga and wait list interventions.

 

Association with MS Society and Preliminary Data

Both the Northern NJ and the Greater NY Chapter of the National MS Society have indicated their willingness to support education about this project and recruitment through their newsletters, e-mail lists, and current programs. The NY Chapter has funded and otherwise supported the “yoga for MS” class at Dr. Alkalay's Center for more than a year. While this class has not been run as a study, the 25 regular participants report improvement in all areas of their lives, including reduced stress and fear, increased energy, and improved physical function, self-image, and self-reliance. The teacher's observations of the students are consistent with these established goals. The proposed yoga intervention for this study will contain much of the same content, with additional mind body practice enrichment, and will be informed by other relevant clinical trials. We will also seek input and feedback from the Advisory Board of the local New Jersey MS society. Individuals at the National MS Society have expressed interest in the project and encouraged our intention to submit to the local and national MS Societies for funding.

Running clinical trials is very expensive. We anticipate that we will need funds in addition to those that may be available from the National MS Society. If you'd like to help support this development work and the clinical trial, any donations will be gratefully accepted and can be made through the Foundation of UMDNJ, specifying the “Yoga for MS project”. You may contact Inya Chehade, MSW, Senior Director of Development, Foundation of UMDNJ, chehadin@umdnj.edu , tel. 973.972.2127, fax 973.972.1240, with questions about making a tax deductible donation or contact us through our website www.umdnj.edu/ICAM Thank you for your time and interest!

In This Issue

"Let food be your medicine and medicine be your food." Hippocrates of Kos

(ca. 460 - ca. 370 BC)

Calendar
ICAM's Mission

ICAM serves as a focal point for complementary & alternative medicine (CAM) within UMDNJ and beyond. Its mission is threefold:

EDUCATION: To be an educational resource on CAM, and to develop evidenced-based integrative curricula and educational programs.

RESEARCH: To facilitate, conduct and obtain support for high quality basic and clinical research in CAM.

CLINICAL: To support the integration of evidence-based CAM therapies and medicine into clinical settings.

Newsletter Credits

Editors... Karen Malone, MA, BA (Hons.), PGCE

Crystal Jones, MPA



 

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