Influence of Iyengar Yoga on the Bio-functional Age of Postmenopausal Women

Postmenopausal Clinical Trial

— IIYBFAPW  

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04705623
• Other study ID #: 2019-01794
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Flushing
• Postmenopausal
• Postmenopausal Flushing

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