Cardiovascular DiseasesTMY_RehabNCT05035758
Transcendental Meditation and Yoga: Short- and Long-term Effects in Cardiac Rehabilitation Patients - a Pilot Study
A study testing Transcendental Meditation and Yoga in people with Cardiovascular Diseases and Vascular Diseases, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Vascular Diseases, Stress, Psychological
- What is being tested?
- Transcendental Meditation and Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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. 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.
- 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.
- Being tested
- Transcendental Meditation, Yoga
- Medical subject headings
- Cardiovascular Diseases, Vascular Diseases, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcendental MeditationOther
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.
YogaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Goups | No intervention | The control group (A) receives standard exercise therapy that is part of the rehabilitation at the center and no additional intervention |
| Transcendental Meditation | Experimental | The intervention group (B) receives transcendental meditation sessions (twice per day for 30 minutes) additionally to the standard rehabilitation therapy. Receives: Other: Transcendental Meditation |
| Yoga | Experimental | The intervention group (C) receives yoga sessions (twice per day for 30 minutes) additionally to the standard rehabilitation therapy. Receives: Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of arterial Stiffness
Arterial Stiffness will be assessed using pulse wave velocity measurement via the vicorder device
Measured: through study completion, an average of 1 year
Change of Retinal Microvasculature
Will be assessed via retinal imaging
Measured: through study completion, an average of 1 year
Changes in heart rate to orthostatic loading
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.
Measured: through study completion, an average of 1 year
Changes in blood pressure to orthostatic loading
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.
Measured: through study completion, an average of 1 year
Changes in Microbiome Samples
Stool samples will be collected to analyse the changes in the microbiome
Measured: through study completion, an average of 1 year
Change in stress levels via cortisol measurements from hair samples
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.
Measured: through study completion, an average of 1 year
Changes in The Pittsburgh Sleep Quality Index (PSQI)
self-report questionnaire that assesses sleep quality over a 1-month time interval
Measured: through study completion, an average of 1 year
Changes in SF-36
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.
Measured: through study completion, an average of 1 year
Changes in POMS - short form
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.
Measured: through study completion, an average of 1 year
Changes in PSQ20
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.
Measured: through study completion, an average of 1 year
Changes in Spielberger State Trait Anxiety Inventory (STAI)
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).
Measured: through study completion, an average of 1 year
Changes in Tryptophan pathway
Tryptophan as stress marker from plasma samples
Measured: through study completion, an average of 1 year
Changes in Kynurenin levels
Kynurenin as stress marker from plasma samples
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Oct 2019
- Primary completion1 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nandu Goswami, MD, Principal investigator, nandu.goswami@medunigraz.at
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035758
- Sponsor's protocol ID
- EK 31-443 ex 18/19
- Acronym
- TMY_Rehab
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcendental Meditation and Yoga: Short- and Long-term Effects in Cardiac Rehabilitation Patients - a Pilot Study
- ClinicalTrials.gov ID
- NCT05035758
- Acronym / sponsor ID
- TMY_Rehab / EK 31-443 ex 18/19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Goups | No intervention | –The control group (A) receives standard exercise therapy that is part of the rehabilitation at the center and no additional intervention |
| Transcendental Meditation | Experimental | Other: Transcendental MeditationThe intervention group (B) receives transcendental meditation sessions (twice per day for 30 minutes) additionally to the standard rehabilitation therapy. |
| Yoga | Experimental | Other: YogaThe intervention group (C) receives yoga sessions (twice per day for 30 minutes) additionally to the standard rehabilitation therapy. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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),
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcendental MeditationIn 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. | Other | Transcendental Meditation |
| YogaIn 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. | Other | Yoga |
Primary outcome
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 of Retinal Microvasculature
Time frame: through study completion, an average of 1 year
Will be assessed via retinal imaging
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
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 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.
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.
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).
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nandu Goswami, MD principal investigator
nandu.goswami@medunigraz.at
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcendental Meditation and Yoga in people with Cardiovascular Diseases and Vascular Diseases, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of arterial Stiffness (time frame: through study completion, an average of 1 year). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.