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

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.

Study Overview

• Status: Recruiting
• Conditions: Postmenopausal; Postmenopausal Flushing
• Intervention / Treatment: Behavioral: Iyengar Yoga

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Petra o Stute, Prof. Dr. med; Phone Number: +41 31 63 2 13 33; Email: petra.stute@insel.ch
• Study Contact Backup: Name: Natascha Rieben, Study Nurse; Phone Number: 0316321327; Email: natascha.rieben@insel.ch

Study Locations

• Switzerland
  • Berne, Switzerland, 3010
    • Recruiting
    • Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern
    • Contact: Petra Stute, MD; Phone Number: +41 31 63 2 13 33; Email: petra.stute@insel.ch
    • Contact: Lara Schmid, study nurse; Phone Number: 0316321303; Email: lara.schmid@insel.ch
    • Principal Investigator: Petra Stute, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Oxidative balance	Change of the climacteric symptom oxidative balance measured at the beginning and after 12 weeks of the intervention	12 weeks

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Petra Stute, Prof. Dr. med, Universitätsklinik für Frauenheilkunde Bern

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Yoga; Biofunctional age
• Additional Relevant MeSH Terms: Skin Manifestations; Flushing
• Other Study ID Numbers: 2019-01794

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Public access to the full protocol, patient dataset and statistical code will not be granted. The principal investigator will have ultimate authority over all of the activities.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No