PostmenopausalIIYBFAPWNCT04705623
Influence of Iyengar Yoga on the Bio-functional Age of Postmenopausal Women
A study testing Iyengar Yoga in people with Postmenopausal and Postmenopausal Flushing, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postmenopausal, Postmenopausal Flushing
- What is being tested?
- Iyengar Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern
Bern, 3010
Petra Stute, MD, +41 31 63 2 13 33, petra.stute@insel.ch
Lara Schmid, study nurse, 0316321303, lara.schmid@insel.ch
About this study
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.
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.
- Conditions
- Postmenopausal, Postmenopausal Flushing
- Being tested
- Iyengar Yoga
- Keywords
- Biofunctional age, Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iyengar YogaBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Iyengar Yoga |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (3)
Hot flushes
Change of the climacteric symptom hot flushes (number per day) measured at the beginning and after 12 weeks of the intervention
Measured: 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
Measured: 12 weeks
Oxidative balance
Change of the climacteric symptom oxidative balance measured at the beginning and after 12 weeks of the intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Sep 2020
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PostmenopausalStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, randomized, controlled, open-labelled, two-armed, interventional clinical trial
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petra Stute, Prof. Dr. med, Principal investigator, Universitätsklinik für Frauenheilkunde Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705623
- Sponsor's protocol ID
- 2019-01794
- Other IDs
- 2019
- Acronym
- IIYBFAPW
- Status last verified
- Feb 2025
- First submitted
- 30 Dec 2020
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Ott S, Pavicic E, Schelker S, Re R, Khattab K, Stute P. G.A study protocol for a randomized controlled trial investigating the influence of Iyengar Yoga on biofunctional age and cardiovascular risk associated biomarker of postmenopausal women. Front Glob Womens Health. 2026 Mar 16;7:1762048. doi: 10.3389/fgwh.2026.1762048. eCollection 2026.
PubMed 41918993
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04705623
- Acronym / sponsor ID
- IIYBFAPW / 2019-01794
- Conditions
- Postmenopausal, Postmenopausal Flushing
- Keywords
- Biofunctional age, Yoga
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single-center, randomized, controlled, open-labelled, two-armed, interventional clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Iyengar YogaThe 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. |
| Control | No intervention | –The control group receives an assessment of their biofunctional status at the beginning and the end of the study (same as the intervention group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iyengar YogaWeekly 90 minute Iyengar Yoga classes taught y a professional instructor. Twice weekly 45 minute self practice of Iyengar Yoga at home by the participants | Behavioural | Intervention |
Primary outcome
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.
Time frame: 12 weeks
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)
3 secondary outcomes
Hot flushes
Time frame: 12 weeks
Level of High sensitive C-reactive protein (HS-CRP)
Time frame: 12 weeks
Oxidative balance
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Derived from this study: PubMed 41918993Ott S, Pavicic E, Schelker S, Re R, Khattab K, Stute P. G.A study protocol for a randomized controlled trial investigating the influence of Iyengar Yoga on biofunctional age and cardiovascular risk associated biomarker of postmenopausal women. Front Glob Womens Health. 2026 Mar 16;7:1762048. doi: 10.3389/fgwh.2026.1762048. eCollection 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petra Stute, Prof. Dr. med principal investigator
Universitätsklinik für Frauenheilkunde Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iyengar Yoga in people with Postmenopausal and Postmenopausal Flushing, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra o Stute, Prof. Dr. med (+41 31 63 2 13 33, petra.stute@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04705623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.