Effects of Iyengar yoga on perceived stress, quality of life and autonomic function in healthy distressed women - a randomised trial

ISRCTN	ISRCTN24518979
DOI	https://doi.org/10.1186/ISRCTN24518979
Protocol serial number	03-06 K
Sponsor	Karl and Veronica Carstens Foundation (Germany)
Funder	Karl and Veronica Carstens Foundation

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Andreas Michalsen
Scientific

Am Deimelsberg 34a
Essen
45276
Germany

Phone	+49 (0)201 8054002
Email	andreas.michalsen@uni-essen.de

Primary study design	Interventional
Study design	Randomised controlled trial with waiting list
Secondary study design	Randomised controlled trial
Scientific title	Effects of Iyengar yoga on perceived stress, quality of life and autonomic function in healthy distressed women - a randomised trial
Study objectives	Three months of Iyengar Yoga training leads to reduced perceived stress, according to the perceived stress scale (PSS)
Ethics approval(s)	Approved by the Ethics Committee of the University Hospital of Essen on 08/03/2006, reference number: 06-2968
Health condition(s) or problem(s) studied	Perceived higher stress according to PSS scale
Intervention	Group A: 3 months Iyengar yoga 2 x 90 minutes per week Group B: 3 months Iyengar yoga 1 x 90 minutes per week Group C: waiting list
Intervention type	Other
Primary outcome measure(s)	Differences between the groups of perceived stress reduction (yoga versus waiting list) after three months of intervention
Key secondary outcome measure(s)	Between group differences (yoga versus waiting list and intensified versus moderate yoga) in: 1. Anxiety 2. Depression scores (state trait anxiety inventory [STAI], hospital anxiety and depression scale [HADS]) 3. Mood and well-being (Profile of Mood States [POMS]) 4. Quality of life (short-form questionnaire-36 [SF-36], heart rate variability and blood pressure during mental and physical stress) 5. Complaint lists 6. Cortisol profiles in saliva samples
Completion date	10/05/2006

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	72
Total final enrolment	72
Key inclusion criteria	1. Women 20 to 55 years of age 2. Higher stress according to PSS 3. Having 3 of 8 stress symptoms: a. Insomnia b. Back pain c. Neck pain d. Fatigue e. Cold hands f. Reduced day-time alertness g. Eating disorder h. Tension-type headache
Key exclusion criteria	1. Severe comorbidity 2. Gravidity 3. Psychiatric disease 4. Severe orthopedic malfunction
Date of first enrolment	04/05/2006
Date of final enrolment	10/05/2006

Am Deimelsberg 34a

Essen
45276
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2012	11/01/2021	Yes	No

11/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.