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NCT Number: NCT07839663

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

Lithuanian University of Health Science Department of Sports Medicine

Kaunas, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. Proprioception and balance

    Time frame: Up to 10 minutes

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

  3. 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.

  4. 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.

  5. Body posture

    Time frame: Up to 5 minutes

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

  6. Musculoskeletal pain

    Time frame: Up to 5 minutes

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

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. Depression, anxiety, and stress

    Time frame: Up to 8 minutes

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

  2. Interoceptive awareness

    Time frame: Up to 8 minutes

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Acronym: WOMEN-WELL

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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