- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07632495
Multicomponent Exercise and Postural Hygiene
Effects of a Postural Hygiene-Based Physical Exercise Program in Older Adult Women
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Zaragoza
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Zaragoza, Zaragoza, 스페인, 50009
- Centro Deportivo Municipal Gran Vía
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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다른: 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.
다른 이름들:
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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Functional Mobility Assessed Using the Timed Up and Go
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Musculoskeletal Symptoms Assessed Using the Nordic Musculoskeletal Questionnaire
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Perceived Changes, Acceptability, and Transfer of Postural Hygiene Strategies
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Ana I. Rodrigo, Catholic University of Murcia
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CE092506
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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