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

NCT04705623 | Recruiting DMC

• 1 other identifier: 2019-01794
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal; Postmenopausal Flushing

Keywords

Biofunctional age; Yoga

Outcome Measures

Primary Outcomes (1)

• 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 = 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)

  12 weeks

Secondary Outcomes (3)

• Hot flushes

  12 weeks

• Level of High sensitive C-reactive protein (HS-CRP)

  12 weeks

• Oxidative balance

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Iyengar Yoga

Control

NO INTERVENTION

The control group receives an assessment of their biofunctional status at the beginning and the end of the study (same as the intervention group).

Interventions

Iyengar Yoga BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participation is only possible for biologically female human beings
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern

Bern, 3010, Switzerland

RECRUITING

Study Officials

• Petra Stute, Prof. Dr. med

  Universitätsklinik für Frauenheilkunde Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra o Stute, Prof. Dr. med

CONTACT

+41 31 63 2 13 33; petra.stute@insel.ch

Natascha Rieben, Study Nurse

CONTACT

0316321327; natascha.rieben@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-center, randomized, controlled, open-labelled, two-armed, interventional clinical trial

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 12, 2021
• Study Start: September 1, 2020
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)