Effects of Yoga and Relaxation on Stress and Quality of Life

Effects of Yoga and Relaxation on Stress and Quality of Life - a Three-armed Randomized Controlled Study

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

Study Overview

• Status: Completed
• Conditions: Stress, Psychological
• Intervention / Treatment: Behavioral: Integrative Yoga; Behavioral: Iyengar Yoga; Behavioral: Mindfulness

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14109
    • Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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: Mindfulness; A 12-week mindfulness intervention designed for the healthy handling of stress.	Behavioral: Mindfulness; A 12-week mindfulness intervention designed for the healthy handling of stress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Date of inclusion (baseline), after 12 weeks, after 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Date of inclusion (baseline)
Hospital Anxiety and Depression Scale (HADS)	Assessing full scale, range 0-42, lower score meaning a better outcome	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)	Assessing full scale, range 0-56, higher score meaning a better outcome	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Behavioral questions: alcohol consumption	Number of alcoholic beverages on average per week in the last month	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Behavioral questions: relaxation	Relaxation behavior on average per week in the last month in minutes	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Behavioral questions: cigarettes	Number of cigarettes on average per week in the last month in minutes	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Medical Outcomes Study Short Form Quality of Life (MOS SF-36)	Assessing full scale, range 0-100, higher score meaning a better outcome	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Zerssen symptom list (B-LR and B-LR')	Assessing full scale, range 20-80, higher score meaning a better outcome	Date of inclusion (baseline), after 12 weeks, after 24 weeks
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.	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Maslach Burnout Inventory (MBI)	Assessing full scale, range 0-96, higher score meaning a better outcome	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Aspects of Spirituality (ASP)	Assessing full scale, range 0-112, higher score meaning a better outcome	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Self-Regulation	Assessing full scale, range 16-96, higher score meaning a better outcome	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Multidimensional Assessment of Interoceptive Awareness (MAIA)	Assessing full scale, range 0-160, higher score meaning a better outcome	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Trauma symptoms (Posttraumatic Checklist, PCL-5)	Assessing full scale, range 0-80, higher score meaning a better outcome	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Mysticism Scale Short Form	Assessing full scale, range 0-32, higher score meaning a better outcome	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Numerical Analog Scales	Assessing stress, back pain, headache, shoulder/neck tension, sleep quality, exhaustion, nervousness, digestive complaints, mood on 0-11 points each.	Date of inclusion (baseline), after 12 weeks, after 24 weeks
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)	Date of inclusion (baseline)
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)	After 12 weeks, after 24 weeks
Bio-electrical Impedance Analysis (BIA)	Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg)	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Dietary Behaviour assessed by Food Frequency Questionaire (Gesundheit Erwachsener in Deutschland, DEGS)	Quantitative description of nutritional habits	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Medication intake	Name of medication and dosage	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Heart Rate Variability (HRV)	24h measuring by Faros 180 (chest)	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Electrodermal Activity (Galvanic Skin Response)	24h measuring by Biovotion Everion device	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Blood Volume Pulse	24h measuring by Biovotion Everion device	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Respiration Rate	24h measuring by Biovotion Everion device	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Interbeat Interval (IBI)	24h measuring by Biovotion Everion device	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Heart Rate (HR)	24h measuring by Faros 180 (chest), Biovotion Everion	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Skin Temperature	24h measuring by Biovotion Everion device	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Blood Oxygenization	24h measuring by Biovotion Everion device	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Body weight (kg)	24h measuring by Biovotion Everion device	Date of inclusion (baseline), after 12 weeks, after 24 weeks
Body Mass Index (kg/m2)		Date of inclusion (baseline), after 12 weeks, after 24 weeks
Waist circumference (cm)		Date of inclusion (baseline), after 12 weeks, after 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative interviews in focus groups interviews	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.	12 weeks after inclusion

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 29, 2019
• Primary Completion (ACTUAL): January 21, 2021
• Study Completion (ACTUAL): June 30, 2021

Study Registration Dates

• First Submitted: July 28, 2019
• First Submitted That Met QC Criteria: July 28, 2019
• First Posted (ACTUAL): July 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Yoga; Stress; Meditation; Education; Progressive muscle relaxation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: RELAx

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No