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Effects of Yoga and Relaxation on Stress and Quality of Life

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ClinicalTrials.gov Identifier: NCT04039074
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Andreas Michalsen, Charite University, Berlin, Germany

Brief Summary:
The aim of this study is to measure the effects of three stress reduction methods on patients with stress and stress associated complaints.

Condition or disease Intervention/treatment Phase
Stress, Psychological Behavioral: Integrative Yoga Behavioral: Iyengar Yoga Behavioral: Education with progressive muscle relaxation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Yoga and Relaxation on Stress and Quality of Life - a Three-armed Randomized Controlled Study
Actual Study Start Date : July 29, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress

Arm Intervention/treatment
Experimental: Integrative Yoga
A 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice.
Behavioral: Integrative Yoga
A 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice.

Active Comparator: Iyengar yoga
A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga).
Behavioral: Iyengar Yoga
A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga).

Active Comparator: Education with progressive muscle relaxation
A 12-week conventional psycho-education involving progressive muscle relaxation.
Behavioral: Education with progressive muscle relaxation
A 12-week conventional psycho-education involving progressive muscle relaxation.




Primary Outcome Measures :
  1. Stress questionnaire (Cohen Perceived Stress Scale, CPSS) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Change from Baseline in the CPSS, range from 0 to 4 in each item. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the positively stated items and then summing across all scale items while higher values meaning a higher grade of perceived stress.


Secondary Outcome Measures :
  1. Medical Outcomes Study Short Form Quality of Life (MOS SF-36) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Assessing full scale, range 0-100, higher score meaning a better outcome

  2. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Assessing full scale, range 0-42, lower score meaning a better outcome

  3. Zerssen symptom list (B-LR and B-LR') [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Assessing full scale, range 20-80, higher score meaning a better outcome

  4. International Physical Activity Questionnaire (IPAQ) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    MET minutes represent the amount of energy expended carrying out physical activity. To get a continuous variable score from the IPAQ (MET minutes a week) we will consider walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS.

  5. Maslach Burnout Inventory (MBI) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Assessing full scale, range 0-96, higher score meaning a better outcome

  6. Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Assessing full scale, range 0-56, higher score meaning a better outcome

  7. Aspects of Spirituality (ASP) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Assessing full scale, range 0-112, higher score meaning a better outcome

  8. Self-Regulation [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Assessing full scale, range 16-96, higher score meaning a better outcome

  9. Multidimensional Assessment of Interoceptive Awareness (MAIA) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Assessing full scale, range 0-160, higher score meaning a better outcome

  10. Trauma symptoms (Posttraumatic Checklist, PCL-5) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Assessing full scale, range 0-80, higher score meaning a better outcome

  11. Mysticism Scale Short Form [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Assessing full scale, range 0-32, higher score meaning a better outcome

  12. Numerical Analog Scales [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Assessing stress, back pain, headache, shoulder/neck tension, sleep quality, exhaustion, nervousness, digestive complaints, mood on 0-11 points each.

  13. Expectation questions [ Time Frame: Date of inclusion (baseline) ]
    For intervention 1, intervention 2 and intervention 3 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all)

  14. Evaluation questions [ Time Frame: After 12 weeks, after 24 weeks ]
    For intervention 1, intervention 2 and intervention 3 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all)

  15. Bio-electrical Impedance Analysis (BIA) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg)

  16. Dietary Behaviour assessed by Food Frequency Questionaire (Gesundheit Erwachsener in Deutschland, DEGS) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Quantitative description of nutritional habits

  17. Medication intake [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Name of medication and dosage

  18. Heart Rate Variability (HRV) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    24h measuring by Faros 180 (chest)

  19. Sociodemographic Measurements [ Time Frame: Date of inclusion (baseline) ]
    Age, gender, education level, household income, employment status, marital status, language spoken, complete family history, current and previous illness and co-morbidities, and current medications

  20. Behavioral questions: alcohol consumption [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Number of alcoholic beverages on average per week in the last month

  21. Behavioral questions: relaxation [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Relaxation behavior on average per week in the last month in minutes

  22. Behavioral questions: cigarettes [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    Number of cigarettes on average per week in the last month in minutes

  23. Electrodermal Activity (Galvanic Skin Response) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    24h measuring by Biovotion Everion device

  24. Blood Volume Pulse [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    24h measuring by Biovotion Everion device

  25. Respiration Rate [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    24h measuring by Biovotion Everion device

  26. Interbeat Interval (IBI) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    24h measuring by Biovotion Everion device

  27. Heart Rate (HR) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    24h measuring by Faros 180 (chest), Biovotion Everion

  28. Skin Temperature [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    24h measuring by Biovotion Everion device

  29. Blood Oxygenization [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    24h measuring by Biovotion Everion device

  30. Body weight (kg) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
    24h measuring by Biovotion Everion device

  31. Body Mass Index (kg/m2) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]
  32. Waist circumference (cm) [ Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks ]

Other Outcome Measures:
  1. Qualitative interviews in focus groups interviews [ Time Frame: 12 weeks after inclusion ]
    Qualitative assessment will be carried out in 45-minute focus group interviews in 12 (randomized selected) patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- stress with a total score of the Cohen scale > 18 for at least 1 month and at least 3 of the following 8 stress symptoms: sleep disorder, inappetence or increased appetite, shoulder neck tension/back pain, tension headache, concentration disorder, exhaustion, nervousness/irritability, stress-associated digestive problems

Exclusion Criteria:

  • serious acute or chronic diseases
  • pregnancy or lactation
  • known serious mental illness
  • immobility or restriction for gymnastics exercises due to orthopaedic, neurological or other medical cause
  • participation in another study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039074


Contacts
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Contact: Miriam Roesner +49 30 80505 682 m.roesner@immanuel.de

Locations
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Germany
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus Recruiting
Berlin, Germany, 14109
Contact: Miriam Rösner, Study nurse    00493080505682    m.roesner@immanuel.de   
Principal Investigator: Andreas Michalsen, Prof. Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Andreas Michalsen, Prof. Dr. Charite - Universitätsmedizin Berlin

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Responsible Party: Andreas Michalsen, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04039074     History of Changes
Other Study ID Numbers: Relax
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreas Michalsen, Charite University, Berlin, Germany:
Yoga
Meditation
Progressive muscle relaxation
Stress
Education
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms