ClinicalTrials.gg
Not yet recruitingNCT07839663WOMEN-WELLUpdated Sep 24, 2026

Comprehensive Assessment of Functional and Psycho-emotional Indicators in Women of Various Ages Participating in Different Health-improvement Programs

An observational study in Female, Female Adolescents and Women, sponsored by Lithuanian University of Health Sciences. Not yet recruiting at 1 site in Lithuania. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Lithuanian University of Health Sciences · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
368
Ages
18 Years to 99 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Female
  • Female Adolescents
  • Women
03

In context

Lead sponsor

Lithuanian University of Health Sciences is the lead sponsor of 105 studies on the registry; 32 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

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:

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • diseases.
  • Obesity, defined as a (BMI) >30 kg/m².
Terms in these criteria, in plain language(2)

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.

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
368 participants (estimated)
Patient registry
No

Groups and cohorts

  • Female that participates in different health-improvement programs
  • Control group

    Female that doesn't participate in different health-improvement programs

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 2 minutes.

  2. Proprioception and balance

    Biodex Balance System SD assessment under different surface, visual, and standing conditions.

    Time frame: Up to 10 minutes

  3. Trunk muscle electrical activity

    Surface EMG assessment of rectus abdominis, multifidus, and internal and external oblique muscle activity during exercises.

    Time frame: Up to 20 minutes

  4. Generalised joint hypermobility

    Beighton score (0-9), supported by goniometry. Higher scores indicate greater hypermobility; the study threshold is ≥5.

    Time frame: Up to 3 minutes

  5. Body posture

    DIERS Formetric 4D surface topography assessment of spinal alignment and posture.

    Time frame: Up to 5 minutes

  6. Musculoskeletal pain

    Lithuanian Nordic Musculoskeletal Questionnaire assessing regional pain or discomfort and associated activity limitations.

    Time frame: Up to 5 minutes

  7. 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.

    Time frame: Up to 1 minute

  8. 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.

    Time frame: Up to 1 minute

  9. 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.

    Time frame: Up to 1 minute

Secondary outcomes

  1. Depression, anxiety, and stress

    DASS-42 with three subscale scores (0-42 each). Higher scores indicate greater symptom severity.

    Time frame: Up to 8 minutes

  2. Interoceptive awareness

    32-item MAIA questionnaire assessing eight dimensions of body awareness, with items rated from 0 (never) to 5 (always).

    Time frame: Up to 8 minutes

07

Study locations

1 site
08

References and documents

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 12191853 ↗
  • Su 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 36498231 ↗
  • de 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 38198361 ↗
  • Kim 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 39829193 ↗
  • Jamil 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Aug 2031, 59 months later.

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

Registered
Sep 14, 2026
First posted
Sep 24, 2026
StartEst.
Sep 21, 2026
Primary completionEst.
Aug 31, 2031
CompletionEst.
Aug 31, 2031
Last update
Sep 24, 2026
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 Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07839663
Responsible party
Algė Daunoravičienė (Associate Professor, Lithuanian University of Health Sciences) — Principal investigator
First posted
Sep 24, 2026
Start date
Sep 21, 2026 (estimated)
Primary completion
Aug 31, 2031 (estimated)
Completion
Aug 31, 2031 (estimated)
Last update
Sep 24, 2026

Study contacts

Lithuanian University of Health Sciences
Contact
rektoratas@lsmu.lt
(0-37) 327201

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion