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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Female; Women; Female Adolescents

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 Type: Observational
• Enrollment (Estimated): 368

Contacts and Locations

• Study Contact: Name: Lithuanian University of Health Sciences; Phone Number: (0-37) 327201; Email: rektoratas@lsmu.lt

Study Locations

• Lithuania
  • Kaunas, Lithuania
    • Lithuanian University of Health Science Department of Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: OTHER
• Time Perspectives: CROSS_SECTIONAL

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Female that participates in different health-improvement programs
Control group; Female that doesn't participate in different health-improvement programs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 2 minutes.
Proprioception and balance	Biodex Balance System SD assessment under different surface, visual, and standing conditions.	Up to 10 minutes
Trunk muscle electrical activity	Surface EMG assessment of rectus abdominis, multifidus, and internal and external oblique muscle activity during exercises.	Up to 20 minutes
Generalised joint hypermobility	Beighton score (0-9), supported by goniometry. Higher scores indicate greater hypermobility; the study threshold is ≥5.	Up to 3 minutes
Body posture	DIERS Formetric 4D surface topography assessment of spinal alignment and posture.	Up to 5 minutes
Musculoskeletal pain	Lithuanian Nordic Musculoskeletal Questionnaire assessing regional pain or discomfort and associated activity limitations.	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.	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.	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.	Up to 1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression, anxiety, and stress	DASS-42 with three subscale scores (0-42 each). Higher scores indicate greater symptom severity.	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).	Up to 8 minutes

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 21, 2026
• Primary Completion (Estimated): August 31, 2031
• Study Completion (Estimated): August 31, 2031

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: September 21, 2026
• First Posted (Actual): September 24, 2026

Study Record Updates

• Last Update Posted (Actual): September 24, 2026
• Last Update Submitted That Met QC Criteria: September 21, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BE-2-127/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No