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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-99
SponsorLithuanian University of Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 25-44 years, 45-59 years, or 60 years and older.

Ability to understand Lithuanian.

Willingness to participate voluntarily in the study.

Women aged 25-44 years, 45-59 years, or 60 years and older.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

368 Participants
are grouped into 2 trial groups
Group A: Female that participates in different health-improvement programs
Group B: Control group

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

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