Multicomponent Exercise and Postural Hygiene
2026年6月2日 更新者：Carmen Daniela Quero Calero、Catholic University of Murcia
Effects of a Postural Hygiene-Based Physical Exercise Program in Older Adult Women
This non-randomized clinical study aims to evaluate whether a multicomponent physical exercise program with integrated postural hygiene can improve functional capacity, postural risk, musculoskeletal symptoms, health-related quality of life, and body composition in adult and older women.
Eighty participants are allocated to three groups: an experimental group performing exercise with integrated postural hygiene, a reference group with previous postural hygiene training performing the same intervention, and a control group performing the same exercise program without the postural hygiene component.
Participants are assessed before, during, and after the intervention, as well as at follow-up.
The broader research project also includes a separate cross-sectional observational component designed to describe postural habits, musculoskeletal symptoms, and functional health-related variables in women enrolled in a community-based Maintenance Gymnastics program.
調査の概要
状態
積極的、募集していない
詳細な説明
The primary component is a non-randomized interventional study with parallel assignment designed to evaluate the effects of a multicomponent physical exercise program integrating postural hygiene strategies. The study is being registered after participant enrollment had started due to an administrative oversight. Data collection is ongoing and has not yet been completed. The intervention protocol, assessment schedule, and outcome measures were defined before completion of data collection and have not been modified based on study findings.
The interventional component includes 80 adult and older women allocated to three groups. The experimental group performs a multicomponent physical exercise program with integrated postural hygiene. The reference group consists of participants who had previously received postural hygiene training and performs the same intervention as the experimental group. The control group performs the same multicomponent physical exercise program without the specific postural hygiene component.
The intervention includes exercises targeting strength, balance, mobility, and postural control. Postural hygiene strategies are integrated throughout exercise practice and are intended to facilitate the transfer of healthy postural behaviors to activities of daily living. These strategies aim to improve postural awareness, movement control, and safer postural habits during functional tasks.
Participants are assessed at four time points: baseline, mid-intervention, post-intervention, and follow-up. Outcomes include functional capacity, postural risk, musculoskeletal symptoms, health-related quality of life, and body composition. Semi-structured interviews are also conducted to explore perceived changes, program acceptability, postural awareness, and the application of postural hygiene strategies in daily life.
The study is non-pharmacological, non-surgical, and non-invasive. It does not involve drug administration, surgical procedures, invasive techniques, or investigational medical devices. The intervention is delivered by trained instructors following a standardized protocol to ensure consistency across groups.
In addition to the interventional component, the broader project includes a separate cross-sectional observational epidemiological study conducted in a larger sample of women enrolled in the Maintenance Gymnastics program. This component is based exclusively on questionnaire data and aims to describe postural habits, musculoskeletal symptoms, body perception, and variables related to functional health in the target population. It does not include any intervention, group allocation, or follow-up assessments.
研究の種類
介入
入学 (実際)
80
段階
- 適用できない
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。
研究場所
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Zaragoza
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Zaragoza、Zaragoza、スペイン、50009
- Centro Deportivo Municipal Gran Vía
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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
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Women enrolled in the Maintenance Gymnastics program
- Age between 50 and 82 years.
- Acceptance of participation in the study.
Exclusion Criteria:
- Having diseases or conditions that prevent the proper performance of the activity and the assessments.
- Having functional limitations that prevent safe participation in physical activity.
- Having cognitive impairments that hinder understanding of instructions, tests, or questionnaires.
- Refusal to participate in the study.
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
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Multicomponent physical exercise with integrated postural hygiene and no prior knowledge
Participants without prior postural hygiene knowledge will perform a structured multicomponent physical exercise program with integrated postural hygiene strategies.
Sessions will follow a previously established common protocol, with the same assessment procedures and time points as the other groups.
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Structured multicomponent physical exercise program including strength, balance, mobility, and postural control exercises, with integrated postural hygiene strategies during exercise execution and activities of daily living.
Sessions will be conducted in the usual practice context, following a previously established common protocol and with implementation control by program instructors.
This intervention will be assigned to the two arms with integrated postural hygiene.
他の名前：
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他の：Multicomponent physical exercise with integrated postural hygiene and prior knowledge
Participants with prior postural hygiene knowledge will perform the same structured multicomponent physical exercise program with integrated postural hygiene strategies as the experimental group.
Sessions will follow a previously established common protocol, with the same assessment procedures and time points as the other groups.
|
Structured multicomponent physical exercise program including strength, balance, mobility, and postural control exercises, with integrated postural hygiene strategies during exercise execution and activities of daily living.
Sessions will be conducted in the usual practice context, following a previously established common protocol and with implementation control by program instructors.
This intervention will be assigned to the two arms with integrated postural hygiene.
他の名前：
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アクティブコンパレータ：Multicomponent physical exercise without postural control
Participants will perform a structured multicomponent physical exercise program including strength, balance, and mobility exercises, but without the specific postural control component.
Sessions will follow a previously established common protocol, with the same assessment procedures and time points as the other groups.
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Structured multicomponent physical exercise program including strength, balance, and mobility exercises, delivered without the specific postural control component.
Sessions will be conducted in the usual practice context, following a previously established common protocol and with implementation control by program instructors.
This intervention will be assigned to the active comparator arm without postural control.
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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 |
|---|---|---|
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Change in Functional Mobility Assessed Using the Timed Up and Go
時間枠：Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
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The Timed Up and Go (TUG) test assesses functional mobility by measuring the time required for a participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down.
Lower values indicate better functional mobility and balance.
Unit of Measure: seconds
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Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
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Change in Physical Performance Assessed Using the Short Physical Performance Battery
時間枠：Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
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The Short Physical Performance Battery (SPPB) assesses physical performance using three standardized components: standing balance, usual gait speed, and the chair stand test.
The balance assessment includes side-by-side, semi-tandem, and tandem standing positions.
Gait speed is evaluated over a short walking distance, and lower-extremity functional strength is assessed using the repeated chair stand test.
Each component is scored from 0 to 4 points, and the total score ranges from 0 to 12 points, with higher scores indicating better physical performance.
Unit of Measure: Points
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Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
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Change in Postural Risk Assessed Using the Rapid Entire Body Assessment
時間枠：Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
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The Rapid Entire Body Assessment (REBA) is an observational ergonomic assessment tool used to evaluate postural risk during functional tasks and movements.
The assessment considers body posture, force/load handling, coupling, and activity level by examining the position of the neck, trunk, legs, upper arms, lower arms, and wrists.
Total scores range from 1 to 15 points, with higher scores indicating greater postural and musculoskeletal risk and lower scores indicating lower postural risk.
Unit of Measure: Points
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Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Musculoskeletal Symptoms Assessed Using the Nordic Musculoskeletal Questionnaire
時間枠：Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
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The Nordic Musculoskeletal Questionnaire (NMQ) is a standardized questionnaire used to assess the presence and anatomical distribution of musculoskeletal symptoms across body regions, including the neck, shoulders, upper back, lower back, elbows, wrists/hands, hips/thighs, knees, and ankles/feet.
The questionnaire records the presence or absence of pain, discomfort, or musculoskeletal symptoms during specified time periods.
Results are reported separately for each body region, with a lower prevalence of symptoms indicating a better outcome.
Unit of Measure: Presence or absence of musculoskeletal symptoms by body region.
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Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
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Change in Health-Related Quality of Life Assessed Using the SF-36 Questionnaire
時間枠：Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
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The 36-Item Short Form Health Survey (SF-36) is a standardized questionnaire used to assess health-related quality of life across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Scores are transformed to a scale ranging from 0 to 100 points, with higher scores indicating better perceived health status and quality of life.
Unit of Measure: Points
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Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
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Change in Body Composition Assessed Using the TANITA BC-401 Monitor
時間枠：Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
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Body composition will be assessed using the TANITA BC-401 body composition monitor.
The following parameters will be recorded: body weight (kg), body fat percentage (%), muscle mass (kg), visceral fat (rating), total body water (%), bone mass (kg), and body mass index (kg/m²).
Higher muscle mass and total body water values, together with lower body fat percentage, visceral fat and BMI values, indicate improved body composition outcomes following the intervention.
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Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
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Postural Awareness Scale
時間枠：Baseline
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The Postural Awareness Scale (PAS) is a self-report questionnaire designed to assess an individual's awareness of body posture, body alignment, and postural sensations during daily activities.
The scale evaluates conscious perception of body position, muscular tension, and postural adjustments.
Higher scores indicate greater postural awareness and improved perception of body posture and movement.
Unit of Measure: points
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Baseline
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Back Pain and Body Posture Questionnaire
時間枠：Baseline
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The Back Pain and Body Posture Evaluation Instrument for Adults (BackPEI-A) is a self-administered questionnaire designed to assess back pain prevalence, postural habits, ergonomic behaviors, and lifestyle-related factors associated with spinal health in adults.
The questionnaire includes items related to pain frequency and intensity, sitting posture, sleeping posture, backpack or load carrying habits, physical activity, and daily postural behaviors.
Higher frequencies of inappropriate postural habits and back pain symptoms indicate poorer spinal health and postural behavior outcomes.
Unit of Measure: categorical responses and frequency scores
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Baseline
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Perceived Changes, Acceptability, and Transfer of Postural Hygiene Strategies
時間枠：Post-intervention.
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Perceived changes following the intervention, intervention acceptability, barriers and facilitators to adherence, body awareness, and transfer of postural hygiene strategies to activities of daily living will be explored through semi-structured interviews conducted with participants from the study groups.
Qualitative data will be analyzed using thematic content analysis to identify common themes and experiences related to the intervention.
Unit of Measure: qualitative thematic categories
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Post-intervention.
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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。
捜査官
- 主任研究者：Ana I. Rodrigo、Catholic University of Murcia
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 (実際)
2025年6月30日
一次修了 (推定)
2026年9月30日
研究の完了 (推定)
2026年9月30日
試験登録日
最初に提出
2026年5月27日
QC基準を満たした最初の提出物
2026年6月2日
最初の投稿 (実際)
2026年6月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月8日
QC基準を満たした最後の更新が送信されました
2026年6月2日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CE092506
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?
はい
IPD プランの説明
The raw data supporting the conclusions of this intervention will be made available by the investigators, without undule reservación, to and qualified researcher.
IPD 共有時間枠
Data will be available upon reasonable request after publication of the main study results and for a period consistent with applicable ethical and data protection requirements.
IPD 共有アクセス基準
De-identified individual participant data may be made available to qualified researchers upon reasonable request for scientific purposes related to this study.
Requests will be reviewed by the research team and, when applicable, by the responsible institution.
Access will only be granted after approval of the request and in accordance with applicable ethical requirements and data protection regulations.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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。