Clinical trial NCT04705623: Influence of Iyengar Yoga on the Bio-functional Age of Postmenopausal Women
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
Overall status: RECRUITING
Phase: NA
Conditions: Postmenopausal
Postmenopausal Flushing
Keywords: Biofunctional age
Yoga
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-center, randomized, controlled, open-labelled, two-armed, interventional clinical trial
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
measure: Hot flushes
timeFrame: 12 weeks
measure: Level of High sensitive C-reactive protein (HS-CRP)
timeFrame: 12 weeks
measure: Oxidative balance
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern
Study officials:
affiliation: Universitätsklinik für Frauenheilkunde Bern
name: Petra Stute, Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
References: