Transcendental Meditation and Yoga: Short- and Long-term Effects in Cardiac Rehabilitation Patients - a Pilot Study
Condition: Cardiovascular Diseases; Vascular Diseases; Stress, Psychological
MeSH terms: Cardiovascular Diseases; Vascular Diseases; Stress, Psychological
Study type: Interventional

Summary: 
      Atherosclerotic cardiovascular disease (CVD) is the leading cause of death in Austria. The
      ESC guidelines recommend cardiac rehabilitation after coronary events (acute coronary
      syndrome, myocardial infarction, etc) with the highest level of evidence. Drug therapy and
      non-pharmacological measures such as a targeted and individualized exercise program, stress
      management programs, reduction of cardiovascular risk parameters through training,
      nutritional counseling, smoking cessation, etc. reduce the cardiovascular risk of recurrence.
      The reduction of psychosocial stress is regarded as one of the major factors in cardiac
      rehabilitation, alongside physical training and nutrition.

      In this study, transcendental meditation (TM) and yoga will be added on top of regular
      cardiac rehabilitation to investigate the efficiency of these methods to possibly improve the
      quality of life of recovering patients. Both methods are believed to reduce stress for users,
      while being relatively easy to introduce to and implement in daily life for beginners,
      carrying no extra cost for them further down the line. The main hypothesis is that cardiac
      patients undergoing rehabilitation plus TM or yoga therapy will show changes in endothelial
      function, micobiome and stress levels. Three groups of 10 participants from a cardiac cardiac
      rehabilitation will be subjected to standard rehabilitation, rehabilitation with meditation,
      and rehabilitation with yoga, respectively. The vascular state of each patient will be
      closely monitored over the 4 weeks, as well as after a 1-year follow up. Furthermore, the
      expected stress reductions will be assessed in short term and long-term by researching hair
      cortisol levels, on top of self-reporting questionnaires.
    

Detailed description: 
      Atherosclerotic cardiovascular disease (CVD) is the leading cause of death in Austria. The
      ESC guidelines recommend cardiac rehabilitation after coronary events (acute coronary
      syndrome, myocardial infarction, etc) with the highest level of evidence. Drug therapy and
      non-pharmacological measures such as a targeted and individualized exercise program, stress
      management programs, reduction of cardiovascular risk parameters through training,
      nutritional counseling, smoking cessation, etc. reduce the cardiovascular risk of recurrence.
      Patients following coronary events will be eligible for in-patient rehabilitation after the
      acute events at the Rehabilitation Center of the Pensionsversicherungsanstalt in St. Radegund
      near Graz. The rehabilitation center with 150 beds is located at an altitude of 717m in the
      spa town of St. Radegund near the provincial capital of Graz at the foot of the Schöckl.

      Substantial epidemiological and mechanistic research has demonstrated that psychosocial
      stress contributes to CVD pathophysiology and clinical events. However, there is paucity of
      clinical trial data on the effects of stress reduction on cardiovascular clinical events. The
      reduction of psychosocial stress is regarded as one of the major goals in cardiac
      rehabilitation, in addition to encouraging exercise and improved nutrition (Yusuf et al.,
      2004). Meditation and Yoga are two different methods that can be performed to increase
      mindfulness and reduce stress.

        1. Transcendental Meditation (TM) Previous controlled clinical studies have reported that a
           selected stress reduction technique, the Transcendental Meditation program (TM) is
           associated with reductions in CVD risk factors. These include hypertension, insulin
           resistance, cigarette smoking, reduced CVD events such as stroke and heart attack, and
           reduced psychosocial stress and surrogate markers of disease such as carotid
           intima-media thickness, left ventricular mass and stress-induced myocardial ischemia. TM
           is also believed to lead to a higher EEG coherence.

           The procedure of Transcendental Meditation (TM) is a technique with a millennia-old
           tradition. For more than 50 years, specially trained and authorized transcendental
           meditation teachers as directed by vedic teacher Maharishi Mahesh Yogi have taught it
           worldwide. It is not coupled to a system of religion (Hinduism, Buddhism, etc.), nor is
           it bound to particular beliefs, intellectual abilities, concentration, physical or
           mental condition.

           The TM technique is described as a simple, natural, effortless procedure that is
           practiced 20 minutes twice a day while sitting comfortably with eyes closed. During the
           practice, it is reported that ordinary thinking processes settle down, and a distinctive
           wakeful hypometabolic state characterized by neural coherence and physiological rest is
           achieved. During the practice of TM, the mind effortlessly and systematically
           experiences finer stages of thought and eventually transcends the finest mental impulse
           to experience a state of restful wakefulness, the ground state of consciousness.

           The technique of TM is a distinct, well-defined meditation program that differs
           fundamentally from all other methods of concentration and contemplation. According to
           scientific studies, three basic mechanisms of meditation are distinguished:

             -  Concentrative Attention Techniques

             -  mindfulness techniques

             -  automatically self-transcending techniques

           The technique of Transcendental Meditation is the main representative of this last
           group. It is practiced twice daily for 15-20 minutes. You sit comfortably on a chair and
           have your eyes closed. During the process of TM meditation, the mind becomes silent, but
           remains fully awake. It allows to achieve a deep relaxation of mind and body. Due to its
           simplicity and efficiency, the technique of transcendental meditation is particularly
           suitable for use in the field of preventive medicine and health education.

        2. Yoga Yoga originated in India thousands of year ago. The practice of yoga unifies the
           mind and body through coordinated breathing (pranayama), movement (asana), and
           meditation (dhyana), which has been known to promote well-being and reduce stress. In
           the last several decades, the millions of practitioners and the rise of yoga studios
           have popularized yoga in the western society.

      Yoga is a form of mind-body fitness that involves a combination of muscular activity and an
      internally directed mindful focus on awareness of the self, breath, and energy. It aims at
      developing an integrated personality, where the growth of physical, mental, social, and
      spiritual planes is equally focused. The advantage of yoga is that its benefits are available
      to a wide range of people, from young to elderly, healthy or sick.

      Yoga has shown promising results in different publications as both an intervention and a
      rehabilitation mean, particularly as an element of lifestyle change for cardiac patients.
      Trials have been run for patients post MI and stroke, and while conclusive evidence is
      necessary to confirm the feasibility of the proposed methods, yoga has been also used by
      patients with heart failure (all classes), and hypertension.

      Although several studies evaluated effects of Transcendental Meditation (TM) and Yoga,
      effects like endothelial function changes, as well as the influence of TM and/or Yoga on the
      physiological functions including vascular function, intima-media thickness of the arteries,
      the gut microbiome and gut barrier function in context of inflammatory parameters have been
      relatively less investigated. Less is known about the effects of TM and Yoga on outcome
      parameters in rehabilitation patients, undergoing 4 weeks of cardiac rehabilitation as well.
      The purpose of this study is to investigate whether interventions such as TM or Yoga during
      inpatient cardiac rehabilitation, in addition to the standard rehabilitation therapy, can
      provide additional benefits in terms of lowering the cardiac risk parameters.

      Aim of the study The overarching aim of this project is to explore how TM or yoga, applied in
      addition to the existing exercise protocol , affects the physiological functions of blood
      vessels (arterial and venous) as well as autonomic function and stress levels. Supine to
      stand test will be carried out to assess how autonomic function is altered with treatment.
      Flow mediated dilatation, intima media thickness, pulse wave velocity and retinal imaging
      will be done to assess the vascular state of each patient over the four weeks of
      rehabilitation and after a one-year follow up. Finally, the stress reductions with TM will be
      assessed in short term and long-term using measurements of hair cortisol levels.
    

Intervention name(s): Transcendental Meditation; Yoga
Intervention type(s): Other; Other
Intervention description(s): In the beginning, the patients from group B will receive an introductory lecture about transcendental meditation (TM) which includes general information, the procedure itself and other techniques of relaxation and personal development.
In this first session the method is learned by practice, in the following 3 meetings additional instructions are given about the correct practice of the TM technique; TM is practiced twice a day for 20 minutes. The method is easy to learn and effortless. To guarantee the right performance of TM by the patients, there will be two group meetings per week and one individual personal meeting with the TM teacher.After discharge from the rehabilitation program (after 4 weeks) there will be meetings offered according to the patients need. This will then be arranged individually.; In addition to the standard rehabilitation exercise training, the patients in this group will receive a 20-minute workshop where they learn how to do the yoga exercise. The initial yoga workshop will be held by Dr. Gilda Wüst who is a yoga expert with a lot of experience based in St. Radegund.
After this, yoga sessions will be included (additionally to the regular/standard exercise) into their daily timetable. Two yoga sessions will be done every day, one in the morning (6:30-6:50) and one in the evening (16:30-16:50) and will last for about 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this study, we will separate the patients into three groups; the control group (A) receives the standard exercise therapy that is part of the rehabilitation at the center. The intervention group B additionally to this standard therapy receives transcendental meditation sessions. Intervention group C also receives the standard rehabilitation exercise training and in addition yoga sessions.
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science