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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Intervention
The intervention group receives weekly 90 minute yoga classes over a course of 12 weeks. They are also asked to do two 45-minute yoga classes at home each week and document these in a Diary.
干预措施: Iyengar Yoga (Behavioral)
Control
The control group receives an assessment of their biofunctional status at the beginning and the end of the study (same as the intervention group).
结局指标
主要结局
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.
时间窗: 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)
次要结局
- Hot flushes(12 weeks)
- Level of High sensitive C-reactive protein (HS-CRP)(12 weeks)
- Oxidative balance(12 weeks)