Multicomponent Exercise and Postural Hygiene
2 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
80
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Zaragoza
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Zaragoza, Zaragoza, Spagna, 50009
- Centro Deportivo Municipal Gran Vía
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
Altri nomi:
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Altro: 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.
Altri nomi:
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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Functional Mobility Assessed Using the Timed Up and Go
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Musculoskeletal Symptoms Assessed Using the Nordic Musculoskeletal Questionnaire
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Perceived Changes, Acceptability, and Transfer of Postural Hygiene Strategies
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Ana I. Rodrigo, Catholic University of Murcia
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
30 giugno 2025
Completamento primario (Stimato)
30 settembre 2026
Completamento dello studio (Stimato)
30 settembre 2026
Date di iscrizione allo studio
Primo inviato
27 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
2 giugno 2026
Primo Inserito (Effettivo)
8 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 giugno 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Dolore
- Manifestazioni neurologiche
- Malattie muscoloscheletriche
- Malattie muscolari
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Dolore muscoloscheletrico
- Fenomeni fisiologici muscoloscheletrici
- Fenomeni fisiologici muscoloscheletrici e neurali
- Tecniche e procedure diagnostiche
- Diagnosi
- Fenomeni fisiologici
- Esame fisico
- Fenomeni fisiologici del sistema nervoso
- Sensazione
- Fenomeni fisiologici vestibulocochleari
- Propriception
- Raggio di movimento, articolare
- Equilibrio posturale
Altri numeri di identificazione dello studio
- CE092506
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
The raw data supporting the conclusions of this intervention will be made available by the investigators, without undule reservación, to and qualified researcher.
Periodo di condivisione 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.
Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .