Postmenopausal Clinical Trial
— IIYBFAPWOfficial title:
A Single-center, Randomized, Controlled, Open-labelled, Two-armed, Interventional Clinical Trial Investigating the Effect of a 12 Week Iyengar Yoga Intervention on the Bio-functional Age of Postmenopausal Women.
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern | Berne |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
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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