Postmenopausal, Postmenopausal Flushing
Conditions
Keywords
Biofunctional age, Yoga
Brief 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.
Detailed 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.
Interventions
BEHAVIORALIyengar 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
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
A single-center, randomized, controlled, open-labelled, two-armed, interventional clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 12 weeks | 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 = Σ (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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hot flushes | 12 weeks | Change of the climacteric symptom hot flushes (number per day) measured at the beginning and after 12 weeks of the intervention |
| Level of High sensitive C-reactive protein (HS-CRP) | 12 weeks | Change of the climacteric symptom Level of HS-CRP (mg/l) measured at the beginning and after 12 weeks of the intervention |
| Oxidative balance | 12 weeks | Change of the climacteric symptom oxidative balance measured at the beginning and after 12 weeks of the intervention |
Countries
Switzerland
Contacts
Primary ContactPetra o Stute, Prof. Dr. med
Backup ContactNatascha Rieben, Study Nurse
Outcome results
None listed