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

NCT07839663 | Not Yet Recruiting

• 1 other identifier: BE-2-127/2026
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Female; Female Adolescents; Women

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• Depression, anxiety, and stress

  Up to 8 minutes

• Interoceptive awareness

  Up to 8 minutes

Study Arms (2)

Female that participates in different health-improvement programs

Control group

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Science Department of Sports Medicine

Kaunas, Lithuania

Location

Related Publications (5)

• 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.

  PMID: 12191853 BACKGROUND

• 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.

  PMID: 36498231 BACKGROUND

• 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.

  PMID: 38198361 BACKGROUND

• 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.

  PMID: 39829193 BACKGROUND

• 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.

  PMID: 40201044 BACKGROUND

Central Study Contacts

Lithuanian University of Health Sciences

CONTACT

(0-37) 327201; rektoratas@lsmu.lt

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 24, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): August 31, 2031
• Study Completion (Estimated): August 31, 2031
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)