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

NCT ID: NCT04705623

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2025-12-31

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.

Conditions

Postmenopausal; Postmenopausal Flushing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Iyengar Yoga

Intervention Type: 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

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petra Stute, Prof. Dr. med

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik für Frauenheilkunde Bern

Locations

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

Bern, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Petra o Stute, Prof. Dr. med

Role: CONTACT

petra.stute@insel.ch

+41 31 63 2 13 33

Natascha Rieben, Study Nurse

Role: CONTACT

natascha.rieben@insel.ch

0316321327

Facility Contacts

Petra Stute, MD

Role: primary

petra.stute@insel.ch

+41 31 63 2 13 33

Lara Schmid, study nurse

Role: backup

lara.schmid@insel.ch

0316321303

Other Identifiers

2019-01794

Identifier Type: -

Identifier Source: org_study_id