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NCT07839663
Comprehensive Assessment of Functional and Psycho-emotional Indicators in Women of Various Ages Participating in Different Health-improvement Programs
Conditions: Female, Female Adolescents, Women
Sex: Female
Ages: 18 Years – 99 Years
Healthy volunteers: No
Enrollment: 368
Sponsor: Lithuanian University of Health Sciences
Location: Lithuanian University of Health Science Department of Sports Medicine Kaunas
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07839663). StuddyBuddy aggregates publicly available trial information.