Transcendental Meditation and Yoga: Short- and Long-term Effects in Cardiac Rehabilitation Patients - a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Changes in heart rate to orthostatic loading
Study Overview
Brief 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients after myocardial infarction (MI)
- •after ST-level myocardial infarction (STEMI) and
- •non ST-level myocardial infarction (NSTEMI)
- •after acute coronary syndrome (ACS)
- •coronary artery disease (CAD) with percutaneous coronary intervention (PCI),
- •after coronary artery bypass graft (CABG)
- •age range 40-80
- •admitted to the cardiac rehabilitatoin center in St. Radegund.
Exclusion Criteria
- •patients who must be monitored because of clinical symptoms (subjects with NYHA III, mini mental score more than 26, or subjects who are not sufficiently mobilized)
- •subjects who regularly perform Yoga exercises or any other meditation techniques
Arms & Interventions
Control Goups
The control group (A) receives standard exercise therapy that is part of the rehabilitation at the center and no additional intervention
Transcendental Meditation
The intervention group (B) receives transcendental meditation sessions (twice per day for 30 minutes) additionally to the standard rehabilitation therapy.
Intervention: Transcendental Meditation (Other)
Yoga
The intervention group (C) receives yoga sessions (twice per day for 30 minutes) additionally to the standard rehabilitation therapy.
Intervention: Yoga (Other)
Outcomes
Primary Outcomes
Changes in heart rate to orthostatic loading
Time Frame: through study completion, an average of 1 year
Patients will be asked to sit for 5 minutes and then stand up straight for 5 minutes. Changes in heart rate during this period will be assessed.
Changes in blood pressure to orthostatic loading
Time Frame: through study completion, an average of 1 year
Patients will be asked to sit for 5 minutes and then stand up straight for 5 minutes. Changes in blood pressure during this period will be assessed.
Changes in Microbiome Samples
Time Frame: through study completion, an average of 1 year
Stool samples will be collected to analyse the changes in the microbiome
Changes in PSQ20
Time Frame: through study completion, an average of 1 year
The aim of the Perceived Stress Questionnaire is to identify and investigate the subjective perception, evaluation and further processing of stressors. This should also question the dominance and objectivity of external stressors.
Change of arterial Stiffness
Time Frame: through study completion, an average of 1 year
Arterial Stiffness will be assessed using pulse wave velocity measurement via the vicorder device
Change in stress levels via cortisol measurements from hair samples
Time Frame: through study completion, an average of 1 year
Hair samples will be collected from the posterior vertex and cut as close to the scalp as possible and cut in pieces with 1 cm each. 1 cm equals 1 month of stress levels. A minimum of 10 mg of hair will be used for each sample.
Changes in The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: through study completion, an average of 1 year
self-report questionnaire that assesses sleep quality over a 1-month time interval
Changes in SF-36
Time Frame: through study completion, an average of 1 year
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients.
Changes in Spielberger State Trait Anxiety Inventory (STAI)
Time Frame: through study completion, an average of 1 year
It consists of two parts (each 20 questions) rating the answers on a 4-point scale. The score for the global test may range between 40-160 points. It evaluates state anxiety (in a specific situation) or trait anxiety (as part of a person´s character).
Change of Retinal Microvasculature
Time Frame: through study completion, an average of 1 year
Will be assessed via retinal imaging
Changes in Tryptophan pathway
Time Frame: through study completion, an average of 1 year
Tryptophan as stress marker from plasma samples
Changes in Kynurenin levels
Time Frame: through study completion, an average of 1 year
Kynurenin as stress marker from plasma samples
Changes in POMS - short form
Time Frame: through study completion, an average of 1 year
POMS measures six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment.
Secondary Outcomes
No secondary outcomes reported