Multicomponent Exercise and Postural Hygiene
2 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
80
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Zaragoza
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Zaragoza, Zaragoza, Espanha, 50009
- Centro Deportivo Municipal Gran Vía
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
Outros nomes:
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Outro: 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.
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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.
Outros nomes:
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Comparador Ativo: 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.
|
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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Functional Mobility Assessed Using the Timed Up and Go
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Musculoskeletal Symptoms Assessed Using the Nordic Musculoskeletal Questionnaire
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Perceived Changes, Acceptability, and Transfer of Postural Hygiene Strategies
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Ana I. Rodrigo, Catholic University of Murcia
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
30 de junho de 2025
Conclusão Primária (Estimado)
30 de setembro de 2026
Conclusão do estudo (Estimado)
30 de setembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
27 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de junho de 2026
Primeira postagem (Real)
8 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de junho de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Dor
- Manifestações Neurológicas
- Doenças musculoesqueléticas
- Doenças Musculares
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor musculoesquelética
- Fenômenos fisiológicos musculoesqueléticos
- Fenômenos fisiológicos musculoesqueléticos e neurais
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Fenômenos fisiológicos
- Exame físico
- Fenômenos fisiológicos do sistema nervoso
- Sensação
- Fenômenos fisiológicos vestibulococleares
- Propriedade
- Amplitude de movimento, articular
- Equilíbrio postural
Outros números de identificação do estudo
- CE092506
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
The raw data supporting the conclusions of this intervention will be made available by the investigators, without undule reservación, to and qualified researcher.
Prazo de Compartilhamento de IPD
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.
Critérios de acesso de compartilhamento IPD
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.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .