FemaleWOMEN-WELLNCT07839663
Comprehensive Assessment of Functional and Psycho-emotional Indicators in Women of Various Ages Participating in Different Health-improvement Programs
An observational study of Female and Female Adolescents, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
This biomedical study will assess and compare functional and psycho-emotional indicators in women of different age groups who participate in Pilates, yoga, or Nirvana Fitness® programmes and women who do not participate in regular physical activity. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Female, Female Adolescents, Women
- How many people
- 368 participants
- Where
- 1 siteLithuania
- Study dates
- 21 Sep 2026to 31 Aug 2031
- Phase
- Observational
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Stage 1: Cross-cultural adaptation of the Nordic Musculoskeletal Questionnaire The study population will comprise women aged 25-44 years (young adults), 45-59 years (middle-aged adults), and 60 years and older (older adults) who understand Lithuanian and voluntarily agree to participate in the study. Stage 2: Prospective observational study The study population will comprise women in the same age groups who understand Lithuanian and voluntarily agree to participate in the study. Participants will be classified into a health promotion programme group or a control group according to whether they participate in a health promotion programme. Women in the programme group will be further classified into subgroups according to the type of programme they practise, such as Pilates or yoga.
Who may be able to join
- Stage 1: Cross-cultural adaptation of the Nordic Musculoskeletal Questionnaire
- Women aged 25-44 years, 45-59 years, or 60 years and older.
- Ability to understand Lithuanian.
- Willingness to participate voluntarily in the study.
- Stage 2: Prospective observational study
- For both the health promotion programme group and the control group:
Show all 16Show fewer
- Women aged 25-44 years, 45-59 years, or 60 years and older.
- Ability to understand Lithuanian.
- Willingness to participate voluntarily in the study.
- No diagnosed acute or chronic disorders.
- Not currently pregnant or breastfeeding, and no pregnancy within the previous two years.
- Additional criteria for the health promotion programme group:
- Regular participation in one of the following programmes for at least one year, at a frequency of at least two to three sessions per week: Pilates, yoga, or Nirvana Fitness®.
- No participation in additional physical activities. Participants in this group will be further classified into subgroups according to the type of health promotion programme they practise.
- Additional criteria for the control group:
- No participation in Pilates, yoga, Nirvana Fitness®, or any other regular physical activity during the previous 12 months.
Who cannot join
- Current pregnancy or being within the first two years after childbirth.
- Current or former professional athlete status.
- Connective tissue disorders, such as Ehlers-Danlos syndrome, Marfan syndrome, or osteogenesis imperfecta.
- Demyelinating or inflammatory neurological diseases.
- Oncological diseases.
- Autoimmune diseases.
- Obesity, defined as a body mass index (BMI) >30 kg/m².
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania1 site
Lithuanian University of Health Science Department of Sports Medicine
Kaunas
About this study
This biomedical study will assess and compare functional and psycho-emotional indicators in women of different age groups who participate in Pilates, yoga, or Nirvana Fitness® programmes and women who do not participate in regular physical activity. The study will evaluate somatosensory, musculoskeletal, and respiratory function, musculoskeletal pain, body awareness, and psycho-emotional status. It will also examine associations between functional and psycho-emotional indicators.
The study consists of two stages. The first stage will involve the translation, cross-cultural adaptation, and validation of the Nordic Musculoskeletal Questionnaire for use in Lithuania. The second stage will be a prospective observational study comparing the assessed indicators across age groups and health promotion programmes. The findings are expected to contribute to the identification of age-appropriate health promotion approaches for women and to inform strategies for maintaining health and functional capacity across the lifespan.
Read the detailed description
Women's health across the lifespan is influenced by interacting biological and sociocultural factors. Historically, the limited inclusion of women in biomedical research has reduced the applicability of clinical evidence to this population. Women's health encompasses physical, psychological, and social dimensions that jointly affect overall well-being and bodily function.
Age-related hormonal changes are associated with an increased risk of chronic conditions, including hypertension, atherosclerosis, and osteoporosis. Sex-related differences are also evident in the musculoskeletal system: men generally have greater muscle mass and bone mineral density, whereas women more frequently experience musculoskeletal pain and may be at increased risk of early sarcopenia. Differences are additionally observed in the respiratory system, with certain chronic pulmonary diseases becoming increasingly prevalent and severe among women.
The somatosensory system, particularly proprioception, plays an important role in balance and movement control and is associated with body awareness and psychological regulation. Depression and anxiety are more common among women and are influenced by both biological and sociocultural factors.
Physical activity is an important modifiable factor that supports cardiovascular, metabolic, musculoskeletal, and respiratory function, as well as psycho-emotional well-being. It may also help reduce menopausal symptoms and the risk of chronic disease. Health promotion programmes such as yoga, Pilates, and Nirvana Fitness® may improve functional mobility and psychological well-being. However, further comparative research is needed to determine how participation in these programmes is associated with women's physical and psycho-emotional health across different age groups.
Studies conducted in Lithuania have predominantly examined individual health promotion programmes. Comparative research is therefore needed to identify age-appropriate approaches that may support women's health and disease prevention.
Study Design and Recruitment
The study comprises two stages: the cross-cultural adaptation and validation of a questionnaire, followed by a prospective observational study.
Participants will be recruited through advertisements published on Facebook, Instagram, and LinkedIn. Before enrolment, prospective participants will receive information about the purpose of the study, study procedures, potential benefits and risks, confidentiality, and their right to withdraw. Written informed consent will be obtained before any study-related procedures are performed.
Stage 1 will involve the translation, cross-cultural adaptation, and validation of the Lithuanian version of the Nordic Musculoskeletal Questionnaire.
Stage 2 will assess somatosensory, musculoskeletal, and respiratory system function, psycho-emotional status, and body awareness in women from different age groups. Women who already participate in selected health promotion programmes will be compared with women who do not regularly participate in such programmes.
Participants will be classified into the health promotion programme group or the control group according to their existing physical activity habits, as specified in the eligibility criteria. Participants in the health promotion programme group will be further classified according to the programme practised: Pilates, yoga, or Nirvana Fitness®. Group classification will be performed by the principal investigator or a designated investigator who is a qualified physiotherapist holding a valid professional licence. No participant will be assigned to begin, discontinue, or change a health promotion programme for the purposes of this observational study.
- Conditions
- Female, Female Adolescents, Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Female that participates in different health-improvement programs | Not described | |
| Control group | Female that doesn't participate in different health-improvement programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Body mass index will be calculated by dividing body weight in kilograms by height in metres squared and will be reported in kilograms per square metre (kg/m²). Higher values indicate greater body mass relative to height.
Measured: Up to 2 minutes.
Proprioception and balance
Biodex Balance System SD assessment under different surface, visual, and standing conditions.
Measured: Up to 10 minutes
Trunk muscle electrical activity
Surface EMG assessment of rectus abdominis, multifidus, and internal and external oblique muscle activity during exercises.
Measured: Up to 20 minutes
Generalised joint hypermobility
Beighton score (0-9), supported by goniometry. Higher scores indicate greater hypermobility; the study threshold is ≥5.
Measured: Up to 3 minutes
Body posture
DIERS Formetric 4D surface topography assessment of spinal alignment and posture.
Measured: Up to 5 minutes
Musculoskeletal pain
Lithuanian Nordic Musculoskeletal Questionnaire assessing regional pain or discomfort and associated activity limitations.
Measured: Up to 5 minutes
Forced expiratory volume in one second
Forced expiratory volume in one second (FEV1) will be measured by spirometry and reported in litres. Higher values indicate a greater volume of air forcibly exhaled during the first second of expiration.
Measured: Up to 1 minute
Forced vital capacity
Forced vital capacity (FVC) will be measured by spirometry and reported in litres. Higher values indicate a greater volume of air forcibly exhaled after maximal inspiration.
Measured: Up to 1 minute
Peak expiratory flow
Peak expiratory flow (PEF) will be measured by spirometry and reported in [litres per second or litres per minute, according to the spirometer output]. Higher values indicate greater peak expiratory flow.
Measured: Up to 1 minute
Secondary outcomes (2)
Depression, anxiety, and stress
DASS-42 with three subscale scores (0-42 each). Higher scores indicate greater symptom severity.
Measured: Up to 8 minutes
Interoceptive awareness
32-item MAIA questionnaire assessing eight dimensions of body awareness, with items rated from 0 (never) to 5 (always).
Measured: Up to 8 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start21 Sep 2026 (estimated)
- Primary completion31 Aug 2031 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FemaleStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Algė Daunoravičienė, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839663
- Sponsor's protocol ID
- BE-2-127/2026
- Acronym
- WOMEN-WELL
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Douchi T, Yamamoto S, Yoshimitsu N, Andoh T, Matsuo T, Nagata Y. Relative contribution of aging and menopause to changes in lean and fat mass in segmental regions. Maturitas. 2002 Aug 30;42(4):301-6. doi: 10.1016/s0378-5122(02)00161-5.
PubMed 12191853Su CH, Peng HY, Tien CW, Huang WC. Effects of a 12-Week Pilates Program on Functional Physical Fitness and Basal Metabolic Rate in Community-Dwelling Middle-Aged Women: A Quasi-Experimental Study. Int J Environ Res Public Health. 2022 Dec 2;19(23):16157. doi: 10.3390/ijerph192316157.
PubMed 36498231de Faria RR, de Siqueira SF, Haddad FA, Del Monte Silva G, Spaggiari CV, Martinelli Filho M. The Six Pillars of Lifestyle Medicine in Managing Noncommunicable Diseases - The Gaps in Current Guidelines. Arq Bras Cardiol. 2024 Jan 8;120(12):e20230408. doi: 10.36660/abc.20230408. eCollection 2024. English, Portuguese.
PubMed 38198361Kim MS, Kim TH. Anti-Aging Tests for Middle Aged Women. J Menopausal Med. 2024 Dec;30(3):164-169. doi: 10.6118/jmm.24012.
PubMed 39829193Jamil A. Beyond the Physical: Understanding the Emotional, Psychological, and Social Factors Affecting Women's Health Today. Cureus. 2025 Apr 8;17(4):e81874. doi: 10.7759/cureus.81874. eCollection 2025 Apr.
PubMed 40201044
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment of Functional and Psycho-emotional Indicators in Women of Various Ages Participating in Different Health-improvement Programs
- ClinicalTrials.gov ID
- NCT07839663
- Acronym / sponsor ID
- WOMEN-WELL / BE-2-127/2026
- Conditions
- Female, Female Adolescents, Women
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2031 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 24 Sep 2026 (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.
This biomedical study will assess and compare functional and psycho-emotional indicators in women of different age groups who participate in Pilates, yoga, or Nirvana Fitness® programmes and women who do not participate in regular physical activity. The study will evaluate somatosensory, musculoskeletal, and respiratory function, musculoskeletal pain, body awareness, and psycho-emotional status. It will also examine associations between functional and psycho-emotional indicators.
The study consists of two stages. The first stage will involve the translation, cross-cultural adaptation, and validation of the Nordic Musculoskeletal Questionnaire for use in Lithuania. The second stage will be a prospective observational study comparing the assessed indicators across age groups and health promotion programmes. The findings are expected to contribute to the identification of age-appropriate health promotion approaches for women and to inform strategies for maintaining health and functional capacity across the lifespan.
Detailed description
Women's health across the lifespan is influenced by interacting biological and sociocultural factors. Historically, the limited inclusion of women in biomedical research has reduced the applicability of clinical evidence to this population. Women's health encompasses physical, psychological, and social dimensions that jointly affect overall well-being and bodily function.
Age-related hormonal changes are associated with an increased risk of chronic conditions, including hypertension, atherosclerosis, and osteoporosis. Sex-related differences are also evident in the musculoskeletal system: men generally have greater muscle mass and bone mineral density, whereas women more frequently experience musculoskeletal pain and may be at increased risk of early sarcopenia. Differences are additionally observed in the respiratory system, with certain chronic pulmonary diseases becoming increasingly prevalent and severe among women.
The somatosensory system, particularly proprioception, plays an important role in balance and movement control and is associated with body awareness and psychological regulation. Depression and anxiety are more common among women and are influenced by both biological and sociocultural factors.
Physical activity is an important modifiable factor that supports cardiovascular, metabolic, musculoskeletal, and respiratory function, as well as psycho-emotional well-being. It may also help reduce menopausal symptoms and the risk of chronic disease. Health promotion programmes such as yoga, Pilates, and Nirvana Fitness® may improve functional mobility and psychological well-being. However, further comparative research is needed to determine how participation in these programmes is associated with women's physical and psycho-emotional health across different age groups.
Studies conducted in Lithuania have predominantly examined individual health promotion programmes. Comparative research is therefore needed to identify age-appropriate approaches that may support women's health and disease prevention.
Study Design and Recruitment
The study comprises two stages: the cross-cultural adaptation and validation of a questionnaire, followed by a prospective observational study.
Participants will be recruited through advertisements published on Facebook, Instagram, and LinkedIn. Before enrolment, prospective participants will receive information about the purpose of the study, study procedures, potential benefits and risks, confidentiality, and their right to withdraw. Written informed consent will be obtained before any study-related procedures are performed.
Stage 1 will involve the translation, cross-cultural adaptation, and validation of the Lithuanian version of the Nordic Musculoskeletal Questionnaire.
Stage 2 will assess somatosensory, musculoskeletal, and respiratory system function, psycho-emotional status, and body awareness in women from different age groups. Women who already participate in selected health promotion programmes will be compared with women who do not regularly participate in such programmes.
Participants will be classified into the health promotion programme group or the control group according to their existing physical activity habits, as specified in the eligibility criteria. Participants in the health promotion programme group will be further classified according to the programme practised: Pilates, yoga, or Nirvana Fitness®. Group classification will be performed by the principal investigator or a designated investigator who is a qualified physiotherapist holding a valid professional licence. No participant will be assigned to begin, discontinue, or change a health promotion programme for the purposes of this observational study.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female that participates in different health-improvement programs | – | – |
| Control group | – | –Female that doesn't participate in different health-improvement programs |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage 1: Cross-cultural adaptation of the Nordic Musculoskeletal Questionnaire The study population will comprise women aged 25-44 years (young adults), 45-59 years (middle-aged adults), and 60 years and older (older adults) who understand Lithuanian and voluntarily agree to participate in the study. Stage 2: Prospective observational study The study population will comprise women in the same age groups who understand Lithuanian and voluntarily agree to participate in the study. Participants will be classified into a health promotion programme group or a control group according to whether they participate in a health promotion programme. Women in the programme group will be further classified into subgroups according to the type of programme they practise, such as Pilates or yoga.
Key inclusion criteria (16 listed)
- Stage 1: Cross-cultural adaptation of the Nordic Musculoskeletal Questionnaire
- Women aged 25-44 years, 45-59 years, or 60 years and older.
- Ability to understand Lithuanian.
- Willingness to participate voluntarily in the study.
- Stage 2: Prospective observational study
Key exclusion criteria (7 listed)
- Current pregnancy or being within the first two years after childbirth.
- Current or former professional athlete status.
- Connective tissue disorders, such as Ehlers-Danlos syndrome, Marfan syndrome, or osteogenesis imperfecta.
- Demyelinating or inflammatory neurological diseases.
- Oncological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body mass index
Time frame: Up to 2 minutes.
Body mass index will be calculated by dividing body weight in kilograms by height in metres squared and will be reported in kilograms per square metre (kg/m²). Higher values indicate greater body mass relative to height.
Proprioception and balance
Time frame: Up to 10 minutes
Biodex Balance System SD assessment under different surface, visual, and standing conditions.
Trunk muscle electrical activity
Time frame: Up to 20 minutes
Surface EMG assessment of rectus abdominis, multifidus, and internal and external oblique muscle activity during exercises.
Generalised joint hypermobility
Time frame: Up to 3 minutes
Beighton score (0-9), supported by goniometry. Higher scores indicate greater hypermobility; the study threshold is ≥5.
Body posture
Time frame: Up to 5 minutes
DIERS Formetric 4D surface topography assessment of spinal alignment and posture.
Musculoskeletal pain
Time frame: Up to 5 minutes
Lithuanian Nordic Musculoskeletal Questionnaire assessing regional pain or discomfort and associated activity limitations.
Forced expiratory volume in one second
Time frame: Up to 1 minute
Forced expiratory volume in one second (FEV1) will be measured by spirometry and reported in litres. Higher values indicate a greater volume of air forcibly exhaled during the first second of expiration.
Forced vital capacity
Time frame: Up to 1 minute
Forced vital capacity (FVC) will be measured by spirometry and reported in litres. Higher values indicate a greater volume of air forcibly exhaled after maximal inspiration.
Peak expiratory flow
Time frame: Up to 1 minute
Peak expiratory flow (PEF) will be measured by spirometry and reported in [litres per second or litres per minute, according to the spirometer output]. Higher values indicate greater peak expiratory flow.
2 secondary outcomes
Depression, anxiety, and stress
Time frame: Up to 8 minutes
Interoceptive awareness
Time frame: Up to 8 minutes
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 24 Sep 2026.
- Background: PubMed 12191853Douchi T, Yamamoto S, Yoshimitsu N, Andoh T, Matsuo T, Nagata Y. Relative contribution of aging and menopause to changes in lean and fat mass in segmental regions. Maturitas. 2002 Aug 30;42(4):301-6. doi: 10.1016/s0378-5122(02)00161-5.
- Background: PubMed 36498231Su CH, Peng HY, Tien CW, Huang WC. Effects of a 12-Week Pilates Program on Functional Physical Fitness and Basal Metabolic Rate in Community-Dwelling Middle-Aged Women: A Quasi-Experimental Study. Int J Environ Res Public Health. 2022 Dec 2;19(23):16157. doi: 10.3390/ijerph192316157.
- Background: PubMed 38198361de Faria RR, de Siqueira SF, Haddad FA, Del Monte Silva G, Spaggiari CV, Martinelli Filho M. The Six Pillars of Lifestyle Medicine in Managing Noncommunicable Diseases - The Gaps in Current Guidelines. Arq Bras Cardiol. 2024 Jan 8;120(12):e20230408. doi: 10.36660/abc.20230408. eCollection 2024. English, Portuguese.
- Background: PubMed 39829193Kim MS, Kim TH. Anti-Aging Tests for Middle Aged Women. J Menopausal Med. 2024 Dec;30(3):164-169. doi: 10.6118/jmm.24012.
- Background: PubMed 40201044Jamil A. Beyond the Physical: Understanding the Emotional, Psychological, and Social Factors Affecting Women's Health Today. Cureus. 2025 Apr 8;17(4):e81874. doi: 10.7759/cureus.81874. eCollection 2025 Apr.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female and Female Adolescents, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 16 inclusion and 7 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: opening soon, as of the sponsor's last update on 24 Sep 2026. 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 Lithuania. 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 Lithuanian University of Health Sciences ((0-37) 327201, rektoratas@lsmu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: Up to 2 minutes.). The study lists 9 primary outcomes in all. 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 NCT07839663, which also lists 5 linked publications.
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 24 Sep 2026.