ClinicalTrials.gg
RecruitingNCT04705623IIYBFAPWUpdated Feb 5, 2025

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

An interventional study of Iyengar Yoga in Postmenopausal and Postmenopausal Flushing, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Sep 2020, registered Dec 2020).
  • Started Sep 2020; still recruiting 6 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Postmenopausal
  • Postmenopausal Flushing

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Keywords

  • Biofunctional age
  • Yoga
03

In context

Flushing

22 studies on the registry are indexed under Flushing; 5 are open to participants now.

This study's planned enrollment of 72 is below the median of 90 across 19 interventional studies indexed under Flushing.

Browse Flushing studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion Criteria:

  • Acute and/or serious disease in the past two years (e.g. Cancer, major surgery)
  • 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 to undergo the investigated intervention
  • Participants incapable of judgement or participants under tutelage Diabetes mellitus
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • 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

  • 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).

Interventions

  • BehavioralIyengar 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

06

What researchers measure

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)

    Time frame: 12 weeks

Secondary outcomes

  1. Hot flushes

    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

  2. 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

    Time frame: 12 weeks

  3. Oxidative balance

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

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern
    Berne, 3010, Switzerland
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2020 (actual). Primary completion is estimated for Mar 2025, 54 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 30, 2020
First posted
Jan 12, 2021
StartActual
Sep 1, 2020
Primary completionEst.
Mar 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Feb 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04705623
Responsible party
Sponsor
First posted
Jan 12, 2021
Start date
Sep 1, 2020
Primary completion
Mar 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Feb 5, 2025

Study contacts

Petra o Stute, Prof. Dr. med
Contact
petra.stute@insel.ch
+41 31 63 2 13 33
Natascha Rieben, Study Nurse
Contact
natascha.rieben@insel.ch
0316321327
Petra Stute, Prof. Dr. med
principal investigator · Universitätsklinik für Frauenheilkunde Bern

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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