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

Primary Purpose

Postmenopausal, Postmenopausal Flushing

Status

Recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Iyengar Yoga

About this trial

This is an interventional basic science trial for Postmenopausal focused on measuring Biofunctional age, Yoga

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Hot flushes

Change of the climacteric symptom hot flushes (number per day) measured at the beginning and after 12 weeks of the intervention

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

Oxidative balance

Change of the climacteric symptom oxidative balance measured at the beginning and after 12 weeks of the intervention

Full Information

NCT ID

NCT04705623

First Posted

December 30, 2020

Last Updated

May 11, 2023

Sponsor

Insel Gruppe AG, University Hospital Bern

1. Study Identification

Unique Protocol Identification Number

NCT04705623

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postmenopausal, Postmenopausal Flushing

Keywords

Biofunctional age, Yoga

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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.

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Iyengar Yoga

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Hot flushes

Description

Change of the climacteric symptom hot flushes (number per day) measured at the beginning and after 12 weeks of the intervention

Time Frame

12 weeks

Title

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

Description

Change of the climacteric symptom Level of HS-CRP (mg/l) measured at the beginning and after 12 weeks of the intervention

Time Frame

12 weeks

Title

Oxidative balance

Description

Change of the climacteric symptom oxidative balance measured at the beginning and after 12 weeks of the intervention

Time Frame

12 weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Participation is only possible for biologically female human beings

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Petra o Stute, Prof. Dr. med

Phone

+41 31 63 2 13 33

petra.stute@insel.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Natascha Rieben, Study Nurse

Phone

0316321327

natascha.rieben@insel.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Petra Stute, Prof. Dr. med

Organizational Affiliation

Universitätsklinik für Frauenheilkunde Bern

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Berne

ZIP/Postal Code

3010

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Petra Stute, MD

Phone

+41 31 63 2 13 33

petra.stute@insel.ch

First Name & Middle Initial & Last Name & Degree

Lara Schmid, study nurse

Phone

0316321303

lara.schmid@insel.ch

First Name & Middle Initial & Last Name & Degree

Petra Stute, M.D.

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Learn more about this trial

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

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