Transcendental Meditation and Yoga: Short- and Long-term Effects in Cardiac Rehabilitation Patients - a Pilot Study

NCT05035758 | Completed DMC

• 1 other identifier: EK 31-443 ex 18/19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Vascular Diseases; Stress, Psychological

Outcome Measures

Primary Outcomes (13)

• Change of arterial Stiffness

  Arterial Stiffness will be assessed using pulse wave velocity measurement via the vicorder device

  through study completion, an average of 1 year

• Change of Retinal Microvasculature

  Will be assessed via retinal imaging

  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.

  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.

  through study completion, an average of 1 year

• Changes in Microbiome Samples

  Stool samples will be collected to analyse the changes in the microbiome

  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.

  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

  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.

  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.

  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.

  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).

  through study completion, an average of 1 year

• Changes in Tryptophan pathway

  Tryptophan as stress marker from plasma samples

  through study completion, an average of 1 year

• Changes in Kynurenin levels

  Kynurenin as stress marker from plasma samples

  through study completion, an average of 1 year

Study Arms (3)

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.

Other: Transcendental Meditation

Yoga

EXPERIMENTAL

The intervention group (C) receives yoga sessions (twice per day for 30 minutes) additionally to the standard rehabilitation therapy.

Other: Yoga

Interventions

Transcendental Meditation OTHER

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.

Transcendental Meditation

Yoga OTHER

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.

Yoga

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Vascular Diseases; Stress, Psychological

Interventions

Meditation; Yoga

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Nandu Goswami, MD

  nandu.goswami@medunigraz.at

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 5, 2021
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: December 31, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

AU (1)