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Effects of Yoga and Relaxation on Stress and Quality of Life

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Integrative Yoga
Iyengar Yoga
Mindfulness
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring Yoga, Meditation, Progressive muscle relaxation, Stress, Education

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- stress with at least 4 of 10 points on the Numeric Analogue Scale (NAS) 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

Sites / Locations

  • Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Integrative Yoga

Iyengar yoga

Mindfulness

Arm Description

A 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice.

A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga).

A 12-week mindfulness intervention designed for the healthy handling of stress.

Outcomes

Primary Outcome Measures

Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
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

Medical Outcomes Study Short Form Quality of Life (MOS SF-36)
Assessing full scale, range 0-100, higher score meaning a better outcome
Hospital Anxiety and Depression Scale (HADS)
Assessing full scale, range 0-42, lower score meaning a better outcome
Zerssen symptom list (B-LR and B-LR')
Assessing full scale, range 20-80, higher score meaning a better outcome
International Physical Activity Questionnaire (IPAQ)
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.
Maslach Burnout Inventory (MBI)
Assessing full scale, range 0-96, higher score meaning a better outcome
Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)
Assessing full scale, range 0-56, higher score meaning a better outcome
Aspects of Spirituality (ASP)
Assessing full scale, range 0-112, higher score meaning a better outcome
Self-Regulation
Assessing full scale, range 16-96, higher score meaning a better outcome
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Assessing full scale, range 0-160, higher score meaning a better outcome
Trauma symptoms (Posttraumatic Checklist, PCL-5)
Assessing full scale, range 0-80, higher score meaning a better outcome
Mysticism Scale Short Form
Assessing full scale, range 0-32, higher score meaning a better outcome
Numerical Analog Scales
Assessing stress, back pain, headache, shoulder/neck tension, sleep quality, exhaustion, nervousness, digestive complaints, mood on 0-11 points each.
Expectation questions
For intervention 1, intervention 2 and intervention 3 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all)
Evaluation questions
For intervention 1, intervention 2 and intervention 3 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all)
Bio-electrical Impedance Analysis (BIA)
Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg)
Dietary Behaviour assessed by Food Frequency Questionaire (Gesundheit Erwachsener in Deutschland, DEGS)
Quantitative description of nutritional habits
Medication intake
Name of medication and dosage
Heart Rate Variability (HRV)
24h measuring by Faros 180 (chest)
Sociodemographic Measurements
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
Behavioral questions: alcohol consumption
Number of alcoholic beverages on average per week in the last month
Behavioral questions: relaxation
Relaxation behavior on average per week in the last month in minutes
Behavioral questions: cigarettes
Number of cigarettes on average per week in the last month in minutes
Electrodermal Activity (Galvanic Skin Response)
24h measuring by Biovotion Everion device
Blood Volume Pulse
24h measuring by Biovotion Everion device
Respiration Rate
24h measuring by Biovotion Everion device
Interbeat Interval (IBI)
24h measuring by Biovotion Everion device
Heart Rate (HR)
24h measuring by Faros 180 (chest), Biovotion Everion
Skin Temperature
24h measuring by Biovotion Everion device
Blood Oxygenization
24h measuring by Biovotion Everion device
Body weight (kg)
24h measuring by Biovotion Everion device
Body Mass Index (kg/m2)
Waist circumference (cm)

Full Information

First Posted
July 28, 2019
Last Updated
September 28, 2022
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT04039074
Brief Title
Effects of Yoga and Relaxation on Stress and Quality of Life
Official Title
Effects of Yoga and Relaxation on Stress and Quality of Life - a Three-armed Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 29, 2019 (Actual)
Primary Completion Date
January 21, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
Yoga, Meditation, Progressive muscle relaxation, Stress, Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrative Yoga
Arm Type
Experimental
Arm Description
A 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice.
Arm Title
Iyengar yoga
Arm Type
Active Comparator
Arm Description
A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga).
Arm Title
Mindfulness
Arm Type
Active Comparator
Arm Description
A 12-week mindfulness intervention designed for the healthy handling of stress.
Intervention Type
Behavioral
Intervention Name(s)
Integrative Yoga
Intervention Description
A 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice.
Intervention Type
Behavioral
Intervention Name(s)
Iyengar Yoga
Intervention Description
A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga).
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
A 12-week mindfulness intervention designed for the healthy handling of stress.
Primary Outcome Measure Information:
Title
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
Description
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.
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Secondary Outcome Measure Information:
Title
Medical Outcomes Study Short Form Quality of Life (MOS SF-36)
Description
Assessing full scale, range 0-100, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Assessing full scale, range 0-42, lower score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Zerssen symptom list (B-LR and B-LR')
Description
Assessing full scale, range 20-80, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
International Physical Activity Questionnaire (IPAQ)
Description
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.
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Maslach Burnout Inventory (MBI)
Description
Assessing full scale, range 0-96, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)
Description
Assessing full scale, range 0-56, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Aspects of Spirituality (ASP)
Description
Assessing full scale, range 0-112, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Self-Regulation
Description
Assessing full scale, range 16-96, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Description
Assessing full scale, range 0-160, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Trauma symptoms (Posttraumatic Checklist, PCL-5)
Description
Assessing full scale, range 0-80, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Mysticism Scale Short Form
Description
Assessing full scale, range 0-32, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Numerical Analog Scales
Description
Assessing stress, back pain, headache, shoulder/neck tension, sleep quality, exhaustion, nervousness, digestive complaints, mood on 0-11 points each.
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Expectation questions
Description
For intervention 1, intervention 2 and intervention 3 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all)
Time Frame
Date of inclusion (baseline)
Title
Evaluation questions
Description
For intervention 1, intervention 2 and intervention 3 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all)
Time Frame
After 12 weeks, after 24 weeks
Title
Bio-electrical Impedance Analysis (BIA)
Description
Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg)
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Dietary Behaviour assessed by Food Frequency Questionaire (Gesundheit Erwachsener in Deutschland, DEGS)
Description
Quantitative description of nutritional habits
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Medication intake
Description
Name of medication and dosage
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Heart Rate Variability (HRV)
Description
24h measuring by Faros 180 (chest)
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Sociodemographic Measurements
Description
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
Time Frame
Date of inclusion (baseline)
Title
Behavioral questions: alcohol consumption
Description
Number of alcoholic beverages on average per week in the last month
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Behavioral questions: relaxation
Description
Relaxation behavior on average per week in the last month in minutes
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Behavioral questions: cigarettes
Description
Number of cigarettes on average per week in the last month in minutes
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Electrodermal Activity (Galvanic Skin Response)
Description
24h measuring by Biovotion Everion device
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Blood Volume Pulse
Description
24h measuring by Biovotion Everion device
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Respiration Rate
Description
24h measuring by Biovotion Everion device
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Interbeat Interval (IBI)
Description
24h measuring by Biovotion Everion device
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Heart Rate (HR)
Description
24h measuring by Faros 180 (chest), Biovotion Everion
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Skin Temperature
Description
24h measuring by Biovotion Everion device
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Blood Oxygenization
Description
24h measuring by Biovotion Everion device
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Body weight (kg)
Description
24h measuring by Biovotion Everion device
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Body Mass Index (kg/m2)
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Title
Waist circumference (cm)
Time Frame
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Other Pre-specified Outcome Measures:
Title
Qualitative interviews in focus groups interviews
Description
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.
Time Frame
12 weeks after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - stress with at least 4 of 10 points on the Numeric Analogue Scale (NAS) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Michalsen, Prof. Dr.
Organizational Affiliation
Charite - Universitätsmedizin Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
City
Berlin
ZIP/Postal Code
14109
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Effects of Yoga and Relaxation on Stress and Quality of Life

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