Yoga for Pelvic Floor Dysfunctions

1. Executive Summary

GoInwards is a brand of Nazakat, Inc. a 501(c)(3) non-governmental organization (NGO). Our aim is to provide innovative educational learning and research-based programs, designed to leverage integrative health services to yield tangible improvements in cognitive health.

GoInwards’ Founders believe that everyone should have access to the tools necessary to manage their physical, emotional, and mental aspects of well-being. Located in Northern Virginia, our organization focuses on the conundrums faced by children, youth, and adults, who are attempting to navigate their daily life, while in the midst of challenging times and adversity across the globe.

We consolidate a plethora of ideas from a broad range of stakeholders, namely the academic institutions, research foundations, public agencies, private entities, and fellow nonprofit organizations. This represents a diverse group of professionals who provide a mosaic of global perspectives, actionable insights, and innovative programming. Together they enable us to create and capitalize on program development and research partnership opportunities.

The GoInwards team has expertise in research, analysis and evaluation, and project management. Our comprehensive framework and program-based model serves to promote empowerment and diverse human development experiences. We strive to provide access to innovative tools that support revitalizing the health and wellbeing across healthcare communities. Through these partnerships, our team promotes wellness programs to incorporate yoga therapy as an integrative medicine.

2. Mission and Goals

The mission of GoInwards is to deliver comprehensive research-based wellness programs and implement solutions to promote mindfulness-based stress reduction practices. The goal is to empower the practitioner to build resilience and self-regulate their physical, emotional and mental state, while navigating the psycho-social dynamics of their domain. Our programs are designed to provide the highest quality of learning and development opportunities to sustain optimal health, maintain equanimity, reset spiritual balance, and unleash the true potential of the human spirit.

Figure 1: GoInwards Philosophy

3. Current Programs and Activities

Figure 2: Integrated Wellness Model

GoInwards has created alliances with academia, research institutes, and several public-private sector firms, which has enabled us to capitalize on partnership opportunities to conduct market research, program, and policy development. The synergies formed through this multidisciplinary ecosystem, serves as an incubator to unveil new paths of research; as our distinguished team of educators, industry professionals, researchers and thought leaders collaborate on strategic policies and programs to address imperative issues.

Our team has developed a robust framework and roadmap to facilitate the analysis of how healthcare systems can integrate mindful-based yoga programs to achieve measurable outcomes. The introduction of yoga as a complementary and alternative therapy option enables patients to expand the scope of integrative medicine, to address a range of physiological conditions. As such, we posit yoga as a therapeutic intervention and a healing modality for managing pelvic floor dysfunctions.

In addition to promoting yoga as a therapeutic healing modality for integrative medicine, our team is also introducing mindfulness-based programs into the Social Emotional Learning (SEL)[1] education curriculum. The strategy in this case is to create customized educational programs that enhance mindful decision-making competencies. Specifically, yoga becomes a platform that supports children and youth by enhancing their cognitive growth, and promotes development of critical skills needed to thrive as resilient, life-long learners.

4. Statement of Need

Integration of complimentary and integrative healing modality for pelvic floor therapy

Urinary frequency and urgency, interstitial cystitis, constipation or bowel strain, irritable bowel syndrome, pain in the pelvic region, painful intercourse, lower-back pain, muscle spasms in the pelvis, are all natural consequences of aging or childbirth, or both. Due to the sensitivity of the issue, women don’t talk about it; however, one in four women can seem to relate. A recent study published in Obstetrics and Gynecology found that nearly 50 percent of all women will at some point in their lives contend with urinary incontinence, whether they ever give birth or not.

Pelvic floor dysfunctions (PFD) refer to the pathological changes of the pelvic floor tissue structure caused by damage, aging, and other causes of the pelvic floor tissue, which ultimately leads to a series of corresponding organ dysfunctions. Its clinical manifestations include lower urinary tract symptoms such as urinary incontinence, lower gastrointestinal symptoms such as pelvic organ prolapse, fecal incontinence, and sexual dysfunction, and a series of symptoms such as pelvic pain.[2]

In particular, there is a predictable increase in the number of women who need to undergo surgical procedures to correct a bladder control problem or pelvic organ prolapse. Thus, researchers are exploring treatment options to address a variety of medical conditions that use minimally invasive treatments to improve the quality of life for women.

Continued research studies into the cause of these underlying symptoms has led to the identification of risk factors such as childbirth, factors putting pressure on the pelvic floor, getting older, weakening tissue, and surgery.[3]

Further study in this area and the prevalence of PFD and surgery as a treatment indicate an escalation in the total number of women who will have surgery will increase 47.2% from 210,700 in 2010 to 310,050 in 2050.[4]

National Institute of Child Health and Human Development (NICHD) seeks to better understand the basic mechanisms of PFDs and the factors, including pregnancy and childbirth-related injuries, that might affect a woman’s risk of developing PFDs. Researchers are also working to develop and evaluate minimally invasive treatments for PFDs.

Thus, an array of complementary and integrative treatment plans together with traditional care, to enhance the overall impact of rehabilitation therapy will be of great value. Finally, NICHD is also striving to better define patient satisfaction, and outcomes that women value the most.

4. Theory of Change

Yoga – A science-based healing modality for pelvic floor dysfunctions

One complementary and integrative intervention for rehabilitation that offers therapeutic benefits is yoga. As a set of physical and mental practices designed to promote overall health and wellbeing, yoga is now being incorporated into behavioral treatment programs for a variety of chronic health conditions including lower back pain, cancer-related symptoms, hypertension, and has specific potential to improve pelvic floor dysfunctions through several mechanisms.

The innovation of this proposed research program is to understand the treatment methods of pelvic floor muscle clusters, and combine them with the recognition of yoga asanas through asana recognition algorithms, to obtain a new type of yoga training method that is helpful for pelvic floor rehabilitation. This method can effectively recover the position of the bladder meridian, the position of the uterus, the position of the ampulla of the rectum, and the area of the hiatus in the pelvic floor.

Figure 3: Systems of the body

By promoting awareness and control over individual muscle groups through the practice of specific yoga postures, yoga can be used to help women identify and strengthen their pelvic floor muscles without the traditional pelvic floor rehabilitation.

With its focus on deep breathing and mindful meditation, yoga can also be useful in reducing anxiety, perceived stress, and associated autonomic nervous system imbalance, which have been identified as risk factors for urgency incontinence in multiple clinical and epidemiologic studies.

Additionally, yoga as a non-invasive practice can improve muscle strength, improve hypothalamic-pituitary-adrenal axis function, regulate hormonal levels, and various body systems.

In contrast to most clinical therapies, yoga can be practiced without continuous or ongoing supervision by the healthcare practitioners, thus offering a potentially accessible and a cost-effective self-management solution, and a therapy model for women.

5. The Logic Model

The goal is to introduce therapeutic yoga interventions that show promise for enhancing mind-body-breath awareness, that result in downstream effects on improving positive behaviors, mental state, health performance, and overall quality of life. When we practice mindfulness repeatedly, our brain changes in good ways, as neuroplasticity causes our brain to absorb and adapt to whatever we repeatedly focus upon – becoming mindful, aware, and present.

The proposed research program provides new insights for the development of a novel, mindfulness-based study designed in the field of yoga as an integrative medicine for pelvic floor therapy.

Figure 4: Theory of Change Logic Model

Yoga therapy can be beneficial to promote awareness and control over individual muscle groups through the practice of specific yoga postures, breathing practices and relaxation techniques. The proposed feasibility study will demonstrate how yoga is an effective tool, that can be leveraged as a preventative measure, to manage and reduce the incidence of pelvic floor dysfunctions.[5]

6. Proposed Program

The proposed ‘Yoga for Pelvic Floor Dysfunctions’ program is based on somatic therapy through the ‘Mind-Body-Breath Awareness’. The basis of this program is to enable the participant to enhance their innate capacity to relax, heal, and strengthen. Our approach facilitates progressive, flexibly paced sessions that accommodates a comfortable, supportive, and nurturing learning environment. The proposed therapy regime, if done correctly, in a non-competitive and relaxed atmosphere, not only relaxes the muscles of the body, but the relaxing impulses travel back to the brain and relaxes the mind, assisting patients to unleash their latent energy reserves.

Figure 6: Rehabilitation approach

Reigniting the brain-body connection through breath and movement can be a powerful component for recovery. Research shows that visualization and meditation can create new neuropathways[6] while weight-bearing movements can improve balance and strength. This program combines internal and external practices of mind-body engagement to address many of the common challenges faced during recovery and rehabilitation process. Research shows that yoga interventions exert positive effects on several factors, including emotional balance, attentional control, cognitive efficiency, anxiety, negative thought patterns, emotional and physical arousal, reactivity, and negative behavior. Additional research has also revealed positive effects of yoga on factors such as concentration, attention, anxiety, stress, mood, resilience, emotional arousal, self-esteem, and coping frequency.[7]

Table 1: Program Description

7. Program Management

A detailed project implementation plan and communications plan will be developed to assign tasks, manage workflow activities, and track various components, milestones; as well as a list of processes and approaches for planning, monitoring, reporting, and controlling the project. Throughout the program, a risk profile will be leveraged to identify, document, and manage risks based on the Governance, Risk, and Compliance (GRC) Framework. Risks will be characterized, prioritized, and mitigation strategies developed for each issue. The risk profile will be continuously monitored and updated throughout the life of the program, with assessments included in the monthly status reports.

The Project Management Plan (PMP) an evolving document, reflective of episodic and abrupt changes, will be updated as necessary. Any adjustments to the schedule in the final PMP (e.g., delay in deliverables, tasks changes), shall be requested during scheduled status meetings, with prior approval by the Program Manager, and reflected in the revised project plan. The formalized management structure built around the Responsible, Accountable, Consulted, and Informed (RACI) framework, will enable the team to ensure collaboration amongst the stakeholders identified, to accomplish the goals and objectives defined for this program.

Figure 7: Notional Project Plan

The project workplan table provides key activities and timelines for managing and controlling the Prepare, Plan, Design, Integrate, Operate and Optimize (PPDIOO) life-cycle phases of this program.

8. Evaluation Plan

The value of offering yoga to small groups of patients is not limited to the potential benefits experienced by each participant, but stands to enhance society at large. This research project and its rigorous scientific evaluation can add to the body of knowledge about the role and outcomes of yoga for pelvic floor therapy. Moreover, on a local level, clear scientific results would support the expansion of the yoga program from the standpoint of practicality and administrative policy.

Design

A “pre and post” assessment design will be used to determine if the participants in this short-term yoga program benefit measurably from the intervention. Aspects of well-being will be measured before the program, and again afterwards. Measured improvement as reported by the participants will support an inference that yoga “made a difference.”

Should the sponsor choose this approach, a “control group” of similar patients who will not receive the intervention will be used to provide far greater scientific validity. The use of a control group will help mitigate extenuating circumstance that may impact study results, for example, unrelated environmental factors, sometimes as trivial as change of seasons. But if two groups are similar, and in similar environments, we will have greater confidence that the treatment was the reason for the change. The control group can obtain the yoga instruction later, after the initial phase of the evaluation is complete.

Procedures

The sessions will be structured to best accommodate the yoga for pelvic floor dysfunction research program and its participants. At this time, as a result of social distancing, it is recommended that the program be conducted virtually. However, with sufficient medical precautions and as the medical climate evolves, the program can be adapted to in-person instruction as needed. The maximum group size for virtual or in-person sessions will be 8-12 participants. Sessions are recommended to take place over 12 weeks, twice a week, one hour per session. However, adjustments can be made to this schedule without impacting effectiveness of the interventions or the scientific design of the program.

Instruments

The focus of this study will be the degree to which women feel they are “getting their life back”. It is intentionally designed as a quality-of-life outcome study. This research will utilize the extremely well known, well validated, and widely used PROMIS-29[8] scale.[9] It is a simple, quick, easily collected survey or interview of participants. PROMIS instruments contain a fixed number of items from seven PROMIS domains: depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities. The seven domains cover the most relevant areas of self-reported health for the greatest majority of people with chronic illness. There are four questions in each of seven domains, each answered on a five-point scale. There is one more question on pain, rated on an 11-point scale, hence a total of 29 items.

The PROMIS-29 was created by hundreds of researchers in a 5-year effort of NIH and has been reported to be useful for several conditions.

Note: additional or different measures may be added at the request of the funding agency.

[8] PROMIS – Patient Reported Outcome Measurement Information System

Factors Affecting Schedule

Conducting the yoga program itself will require publicizing its availability, and then offering the program by randomizing half of the interested population to participate in the study. The practice setting is customized for each participant based on their needs. For example, chair yoga has been offered as an option to support some participants’ physical limitations.

Analysis

There will be a “pre and post” control group assessment to identify differences. Some studies will utilize the parametric Student’s t distribution for independent samples and nonparametric Mann-Whitney U, while other group changes – the paired t distribution and the Wilcoxon. More elaborate analyses such as multiple regression are always desirable and would increase the validity of our modest sample size.

Evaluation Summary

This research plan provides a direct and consistent measurement strategy for assessing the effectiveness of yoga for pelvic floor therapy. Through the use of PROMIS-29 questionnaire, the hypothesis “does yoga improve the quality of life for patients” will be answered. The outcome of this proposed research project is expected to prove that yoga is a viable therapy for patients with PFD. This is based on the results to be obtained from the target population of patients identified with PFD, who have access to this cost-effective therapy as an acceptable treatment modality.

Appendix A – Physiological effects of yoga

Yoga is an ancient science which has been passed on from generations to generations and has aided in improving the overall health and wellbeing of humanity. From its effects on the nervous system to musculoskeletal system to regulation of the hormones at a cellular level, it has aided in improving the symptoms of various ailments and improving the overall health of a human being. Apart from physical health, it also leads to the improvement of the mental health by leading to mental relaxation by the activation of the parasympathetic system and decreasing the sympathetic tone of the body.

The various postures or postures in Yoga have a significant effect on the musculoskeletal system of the body. The isometric contraction leads to an improved contractile strength of the muscles by increasing the cross-sectional area of the muscles and the stretching leads to the addition of the sarcomeres in series in the various muscle groups. Also, the passive stretch of the muscles leads to increased oxidative enzyme secretion of the muscles as well as increment of the capillaries in the muscle bed, hence leading to better functioning of the muscles. The poses also improve the mobility and strengthening of the joints of the spine and hence aiding in the various ailments of the back. There is an overall improvement of the blood supply to the spinal joints and decreased pressure on the intervertebral discs, hence decreasing the risk of prolapsed disc. There is also an improvement of the strength of the muscles of the lower back, hence leading to an improvement of the posture. It has also been proven that these poses are beneficial in patients of carpal tunnel syndrome as these lead to improved movement of the wrist joint and hence decreasing the pressure on the median nerve and also improvement of the blood supply, which leads to an overall decrease in the ischemic effects on the median nerve.

Yoga has proven to be advantageous in the improvement of the function of the nervous system. There is an overall activation of the parasympathetic system which leads to the relaxation of the body and the inhibition of the sympathetic nervous system. Yoga also improves the focus and memory of a person practicing the science by the activation of the default mode network in the brain. The various postures of yoga also lead to improved coordination and balance of the body by improved coordination between the sensory peripheral proprioceptive and central vestibular pathways and the motor neuronal pathways. It also has been hypothesized that Yoga leads to an overall increase in the pain threshold and pain acceptance. Apart from the nervous system, Yoga has effects on the mental health of the person. It has significant effect on patients suffering from depression as it leads to surges in the dopamine, serotonin and GABA levels and also leads to a decrease in the levels of cortisol in the body. It also leads to improvement in sleep hygiene and hence relieving insomnia.

The breathing techniques have a significant effect on respiratory physiology of the patient. Not only does it lead to overall relaxation by the activation of the parasympathetic system, but it also leads to an improvement of the respiratory function by improving the strength of the intercostal muscles, abdominal muscles and diaphragm. There is also an increase in the vital capacity of the lungs by regular breathing exercises. Apart from the vital capacity, it also improves the various respiratory functions of the body and also leads to a decrease in the oxygen consumption by the tissues in healthy individuals.

Yoga has an encouraging effect on the blood and cardiovascular system of the body by decreasing the levels of the triglyceride levels, LDL (Low Density Lipoproteins) and total cholesterol levels. This leads to the decrease in the incidence of atherosclerosis and hence various ailments associated with the heart and vessels across the body. There have been reports which also document the decreased blood glucose levels in patients of diabetes and an increase in the levels of HDL (High Density Lipoproteins) in the blood. The activation of the parasympathetic system also leads to decrease in hypertension and other heart diseases. There is also an improvement in lymphedema in the patients by increasing the drainage of the lymphatic fluid, lymph angiogenesis and improved muscle contractions and relaxations.

Apart of working at a systemic level, Yoga works at a molecular level as well by regulating the levels of the hormones, neurotransmitters and inflammatory molecules. Stress leads to the activation of the sympathetic system and hence the rise of the serum cortisol levels. This leads to a decrease in the levels of immunity of the body and hence increased susceptibility to infections. Yoga leads to the inhibition of the sympathetic system and hence an overall decrease in the stress hormones of the body. There is also a decrease in the levels of the pro-inflammatory and inflammatory cytokines which leads to a decrease in the various ailments. There is enhancement of the function of the hypothalamic-pituitary-adrenal axis which leads to an overall decrease of the levels of ACTH and cortisol levels. An overall improvement of the blood flow to the endocrinal glands also improves the function of the endocrinal glands and hormonal homeostasis of the body.

Appendix B – Effect of breathwork on physiology

Pranayama is a yogic practice of breathing which houses various breathing techniques such as alternate nostril breathing, deep breathing, diaphragmatic breathing and breath holding under its umbrella. The breathing technique is believed to have significant beneficial effects not only on the respiratory system but also the cardiovascular and the nervous system.

It has been hypothesized that the various breathing techniques lead to an overall improved respiratory function. These techniques lead to increased dilation of the trachea, bronchi and bronchioles and improved distension of the alveoli which improves respiration. This improved distension facilitates the diffusion of the gases across the alveolar – capillary membrane and hence an enhanced oxygenation of the tissues. Moreover, these improve the functioning of the various respiratory muscles of the thorax and abdomen leading to improved respiratory dynamics. Additionally, there is the clearance of the respiratory secretions from the respiratory tree and an overall decrease in the pro-inflammatory cytokines and mast cell degranulation which reduce various pathologies and prevents disease incidence and progression.

The breathing techniques also improve the cardiovascular function. The increased expiratory – inspiratory ratio in the alternate nostril breathing leads to an overall decrease in the heart rate as inspiration leads to an increase and expiration leads to a decrease in the heart rate. The same is regulated by the vagus nerve (parasympathetic innervation). The slow breathing patterns leads to increased baroreflex activation and decreased chemoreflex activation. The same decreases the systolic and diastolic blood pressures and aids in the improvement of blood pressure regulation in hypertensive patients.

Apart from the activation of the parasympathetic autonomic nervous system and hence relaxing the body, the breathing techniques also have a significant effect on the central nervous system. The neurohormonal regulation leads to the overall improvement of learning and memory functions and a decreased incidence of the various psychiatric illnesses such as depression and OCD. With the increased association of the areas of the brain regulating attention, awareness and emotional processing, there is significant decline in negative affect and anxiety as well.

Appendix C – Benefits of meditation

Since the very ancient time, people of the East and West have known about the benefits of meditation. Mediation is an integral component of Yoga and promotes mindfulness and overall improvement of the psychological and behavioral health. But the benefits of meditation are not restricted to the mental, emotional and spiritual aspects but the physical health as well.

Meditation plays a significant effect in the functioning of the central nervous system. The various parts of the brain are connected to each other by deep seated networks, and it is the coordination amongst these networks which regulate the cognitive functions. The Default Mode Network regulates memory, theory and planning in the mind, Task Positive network controls attention and task related thoughts, stimuli are controlled by the Salience network and Executive Network controls the resources to control the current and future demands. Mediation helps regulate and enhance these functions leading to the harmonious functioning of these networks. It has also been proposed that meditation also increases the blood flow to the brain and also increased white matter concentration of the brain. The Locus Coeruleus is believed to regulate attention and respiration in the body. The Locus Coeruleus is chemo-sensitive and regulates the function of the vagus nerve. Meditation enhances the function of the same and hence improves the overall respiration and oxygenation of the tissues in the body. Apart from this, the psychological impact of meditation has been known for ages. The regulation of the various neurohormonal levels and the decrease of the stress hormones leads to the decreased incidence and prevalence of diseases such as depression, anxiety, OCD etc.

Meditation also decreases the activity of the sympathetic system and enhances the effect of the parasympathetic system. This plays a crucial role in the regulation of the cardiovascular health of the body. The increased parasympathetic autonomic nervous system activation leads to a decreased heart rate, a decreased blood pressure and decreased incidence of atherosclerotic diseases. It has also been proposed that meditation decreases the psychological stresses which proves beneficial to prevent the various cardiovascular diseases. The decreased levels of stress hormones such as catecholamines and cortisol leads to the decreased arterial vasoconstriction and incidence of arrhythmias hence decreased incidence of myocardial infarction. This also leads to decreased hypercoagulability and atheroma formation in the blood vessels which again decreases the incidence of myocardial infarction.

Meditation not only affects the somatic systems but also has been proposed to have an effect at a cellular level. Telomeres are the ends of the chromosomes which increase chromosomal stability and telomerases are the enzymes which regulate the same. Shorter lengths of telomeres are associated with aging and other diseases. Meditation has an enhancing effect on the regulation of telomerases and telomeres and hence improves the well-being of an individual. It is also hypothesized that meditation decreases the various pro-inflammatory cytokines and reactive oxygen species levels and increases the levels of anti-inflammatory cytokines, neurotrophins and endorphins. This leads to improved immunity and decreased effects of the various pathologies across the body.

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