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

21 septembre 2026 mis à jour par: Algė Daunoravičienė, Lithuanian University of Health Sciences

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

368

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Lithuanian University of Health Sciences
  • Numéro de téléphone: (0-37) 327201
  • E-mail: rektoratas@lsmu.lt

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 99 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: OTHER
  • Perspectives temporelles: CROSS_SECTIONAL

Cohortes et interventions

Groupe / Cohorte
Female that participates in different health-improvement programs
Control group

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Body mass index
Délai: 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.

Up to 2 minutes.
Proprioception and balance
Délai: Up to 10 minutes

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

Up to 10 minutes
Trunk muscle electrical activity
Délai: Up to 20 minutes

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

Up to 20 minutes
Generalised joint hypermobility
Délai: Up to 3 minutes

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

Up to 3 minutes
Body posture
Délai: Up to 5 minutes

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

Up to 5 minutes
Musculoskeletal pain
Délai: Up to 5 minutes

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

Up to 5 minutes
Forced expiratory volume in one second
Délai: 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.

Up to 1 minute
Forced vital capacity
Délai: 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.

Up to 1 minute
Peak expiratory flow
Délai: 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.

Up to 1 minute

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Depression, anxiety, and stress
Délai: Up to 8 minutes

DASS-42 with three subscale scores (0-42 each). Higher scores indicate greater symptom severity.

Up to 8 minutes
Interoceptive awareness
Délai: Up to 8 minutes

32-item MAIA questionnaire assessing eight dimensions of body awareness, with items rated from 0 (never) to 5 (always).

Up to 8 minutes

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

21 septembre 2026

Achèvement primaire (Estimé)

31 août 2031

Achèvement de l'étude (Estimé)

31 août 2031

Dates d'inscription aux études

Première soumission

14 septembre 2026

Première soumission répondant aux critères de contrôle qualité

21 septembre 2026

Première publication (Réel)

24 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • BE-2-127/2026

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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