このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2026年9月21日 更新者: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.

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

観察的

入学 (推定)

368

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Lithuanian University of Health Sciences
  • 電話番号:(0-37) 327201
  • メール:rektoratas@lsmu.lt

研究場所

      • Kaunas、リトアニア
        • Lithuanian University of Health Science Department of Sports Medicine

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~99年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:OTHER
  • 時間の展望:CROSS_SECTIONAL

コホートと介入

グループ/コホート
Female that participates in different health-improvement programs
Control group

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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Body mass index
時間枠: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
時間枠:Up to 10 minutes

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

Up to 10 minutes
Trunk muscle electrical activity
時間枠: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
時間枠: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
時間枠:Up to 5 minutes

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

Up to 5 minutes
Musculoskeletal pain
時間枠: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
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Depression, anxiety, and stress
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月21日

一次修了 (推定)

2031年8月31日

研究の完了 (推定)

2031年8月31日

試験登録日

最初に提出

2026年9月14日

QC基準を満たした最初の提出物

2026年9月21日

最初の投稿 (実際)

2026年9月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月24日

QC基準を満たした最後の更新が送信されました

2026年9月21日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • BE-2-127/2026

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する