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临床试验/NCT07839663
NCT07839663尚未招募不适用

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

Lithuanian University of Health Sciences1 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2026年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
368
试验地点
1
主要终点
Body mass index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Control group

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

Female that participates in different health-improvement programs

结局指标

主要结局

Body mass index

时间窗: 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.

Proprioception and balance

时间窗: Up to 10 minutes

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

Trunk muscle electrical activity

时间窗: Up to 20 minutes

Surface EMG assessment of rectus abdominis, multifidus, and internal and external oblique muscle activity during exercises.

Generalised joint hypermobility

时间窗: Up to 3 minutes

Beighton score (0-9), supported by goniometry. Higher scores indicate greater hypermobility; the study threshold is ≥5.

Body posture

时间窗: Up to 5 minutes

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

Musculoskeletal pain

时间窗: Up to 5 minutes

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

Forced expiratory volume in one second

时间窗: 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.

Forced vital capacity

时间窗: 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.

Peak expiratory flow

时间窗: 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.

次要结局

  • Depression, anxiety, and stress(Up to 8 minutes)
  • Interoceptive awareness(Up to 8 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Algė Daunoravičienė

Associate Professor

Lithuanian University of Health Sciences

研究点 (1)

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