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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04705623
Other study ID # 2019-01794
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date February 2024

Study information

Verified date May 2023
Source University Hospital Inselspital, Berne
Contact Petra o Stute, Prof. Dr. med
Phone +41 31 63 2 13 33
Email petra.stute@insel.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this Study is to find out if Iyengar-Yoga has a rejuvenating effect on women after menopause. The biofunctional status of the study participants will be assessed before and after a 12-week yoga program.


Description:

Postmenopausal women qualifying as participants for the study are patients at the Universitätsklinik für Frauenheilkunde in Bern or are recruited through public advertisement. After giving informed consent the patients will be screened for inclusion and exclusion criteria and their biofunctional Status will be assessed. The participants of the study will then be randomly assigned to the intervention group (12 week yoga program) or to the control group. In addition to the 90 minutes yoga sessions instructed by a professional yoga teacher, the participants of the intervention group are asked to perform two yoga sessions lasting 45 minutes per week at home and document these in a diary. After the 12 weeks the biofunctional Status of all participants of the study will be reassessed.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date February 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Informed consent - Women after Menopause (defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40mlU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy) - Age over 18 years - At least 4 hot flushes per day (examined through the Menopause rating scale MRS-II) - No regular yoga practice for two years - German as native language - Willing to participate in 12 yoga classes as well as two 45 self practice sessions per week - Willing to assess biofunctional Status and give blood samples Exclusion Criteria: - Acute and/or serious disease in the past two years (e.g. Cancer, major surgery) - Autoimmune or chronic inflammatory disease (e.g. rheumatism, thyroid dysfunction) - Mental illness (e.g. Depression or anxiety disorder (HADS >8)) - Acute or chronic back pain or herniated vertebral disc - Compulsion to participate in the trial - Attendance of less than 10 yoga lessons out of 12. - Hormone replacement therapy (HRT) - Smoking > 20 Cigarettes per day or over 20 packyears - Consumption of >30g alcohol per day (>1 liter of beer or >0.3 dl of wine) - Previous periodic participation in yoga classes within the last two years - Inability or contraindications to undergo the investigated intervention - Participants incapable of judgement or participants under tutelage Diabetes mellitus

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Iyengar Yoga
Weekly 90 minute Iyengar Yoga classes taught y a professional instructor. Twice weekly 45 minute self practice of Iyengar Yoga at home by the participants

Locations

Country Name City State
Switzerland Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern Berne

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Decrease of the biofunctional age (BFA) through a 12 week Iyengar yoga intervention compared to the control group with no yoga classes. In order to evaluate the BFA a biofunctional Status (BFS) has to be assessed. The BFS is a generic, age- and sex-specific test battery comprising holistic characteristics from physical, mental-emotional and social areas. The single values of the BFS test battery were scaled and differentiated for chronological age (CA) and sex. Their summation makes up the so-called Bio-functional Age Index BFAI (BFAI = S (B-X/B-L)n/n). The BFAI is a relative measure compared to a reference population, out of which norm charts were developed. By definition, the reference population's BFAI is identical with its CA. A BFAI of an individual may be transformed into BFA (years) by means of gerontologic aging tables. This BFA (years) relates to the mean value of a certain CA. The BFA is based on a sex-specific regression and factor analysis of functional age (Mathieu et al., 2018. Illness perception in overweight and obesity and impact on bio-functional age. Archives of gynecology and obstetrics, 298(2), p. 417) 12 weeks
Secondary Hot flushes Change of the climacteric symptom hot flushes (number per day) measured at the beginning and after 12 weeks of the intervention 12 weeks
Secondary Level of High sensitive C-reactive protein (HS-CRP) Change of the climacteric symptom Level of HS-CRP (mg/l) measured at the beginning and after 12 weeks of the intervention 12 weeks
Secondary Oxidative balance Change of the climacteric symptom oxidative balance measured at the beginning and after 12 weeks of the intervention 12 weeks
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