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Идёт набор NCT07360626

Exercise and Health Education for Textile Workers: A Pre-Post Study

Без фазы С лечением Musculoskeletal Disorders (MSDs) Musculoskeletal Diseases or Conditions

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Combined Exercise Training and Health Education Program.
Кому может быть актуально
Состояния в реестре: Musculoskeletal Disorders (MSDs), Musculoskeletal Diseases or Conditions. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effectiveness of an Exercise and Health Education Program for Health Promotion in Textile Workers: A Pre-Post Intervention Study

Обзор

Musculoskeletal disorders (MSDs) significantly impact quality of life, health status, and work ability. Standard treatments include ergonomic interventions, therapeutic exercise programs, education on risk prevention, active breaks, and physiotherapy. This study aims to assess the current physical and psychosocial condition of textile manufacturing workers and to evaluate the impact of a combine exercise and health education program on their physical and psychosocial outcomes. The eight-week intervention consists of a weekly in-person workshops and two asynchronous online exercise sessions per week via a mobile app, with exercises adjusted based on participant feedback. Participants will be recruited from voluntary textile workers at Lacor Textil, S.L., aged 18-65, with active employment. All participants will receive the intervention program. Primary objectives are to assess the baseline physical and psychosocial condition of participants and to evaluate the effects of the eight-week intervention on their physical fitness, musculoskeletal health, and overall psychosocial well-being Secondary objectives are to examine changes in the intensity and location of musculoskeletal pain and discomfort, the prevalence of symptoms in different body regions, upper and lower body strength using standardized tests, work ability and perception of work performance, and psychosocial and cognitive factors including sleep quality, stress, anxiety, depression, productivity, and quality of life. Hypothesis: The implementation of an eight-week physical exercise and health education program in textile workers will reduce perceived musculoskeletal discomfort and pain, and improve their physical fitness and psychosocial well-being.

Подробное описание

The protocol uses a quasi-experimental, single-group pre-post design without a control group, conducted in a real occupational setting. All participants will undergo an 8-week intervention program, followed by a 4-week follow-up period. The intervention adopts a hybrid format, combining face-to-face sessions at the workplace with asynchronous online exercise sessions delivered through a mobile application.

Prior to the intervention, participants will undergo a comprehensive baseline assessment to allow for individualized exercise prescription. The same assessment protocol will be repeated at the end of the 8-week intervention and again at the 4-week follow-up.

The intervention includes:

Eight on-site workshops (one per week during working hours), addressing topics such as musculoskeletal pain management, self-efficacy, physical exercise, mobility, stress management, sleep hygiene, and healthy lifestyle habits.

Two weekly online exercise sessions, delivered asynchronously via a digital platform, focusing on mobility, core stability, and progressive strengthening of the upper and lower limbs and spinal stabilizing muscles.

Exercise programs will be progressive and adapted to participants' perceived exertion and functional capacity. Adherence will be monitored through attendance records and digital tracking of completed exercise sessions. Participants must complete at least 80% of the intervention to be included in the final analysis.

Outcome measures include perceived pain intensity, musculoskeletal symptom prevalence, upper and lower limb muscle strength, physical activity level, work ability, sleep quality, psychosocial factors (stress, anxiety, and depression), health-related quality of life, and work productivity and absenteeism. All measurements are performed using validated instruments and standardized protocols.

Вмешательства

  • Другое Combined Exercise Training and Health Education Program
    The intervention consists of an 8-week hybrid program combining exercise training and workplace-based health education. Eight on-site educational workshops (one per week) are delivered during working hours and address topics related to pain management, physical activity, stress management, and healthy lifestyle behaviors, including review and discussion sessions. The exercise training includes two weekly sessions delivered through a mobile application (RehBody platform). Sessions begin with a w

Первичные конечные точки

  • Change in Pain Intensity [Срок оценки: From baseline to end of treatment (8 weeks) and 4-week follow-up.]
Вторичные конечные точки (9)
  • Change in Musculoskeletal Symptoms [Срок оценки: From baseline to end of treatment (8 weeks) and 4-week follow-up.]
  • Change in Upper Limb Muscle Strength [Срок оценки: From baseline to end of treatment (8 weeks) and 4-week follow-up.]
  • Change in Lower Limb Muscle Strength [Срок оценки: From baseline to end of treatment (8 weeks) and 4-week follow-up.]
  • Change in Physical Activity Level [Срок оценки: From baseline to end of treatment (8 weeks) and 4-week follow-up.]
  • Change in Work Ability [Срок оценки: From baseline to end of treatment (8 weeks) and 4-week follow-up.]
  • Sleep Quality [Срок оценки: From baseline to end of treatment (8 weeks) and 4-week follow-up.]
  • Changes in Depression, Anxiety and Stress [Срок оценки: From baseline to end of treatment (8 weeks) and 4-week follow-up.]
  • Change in Quality of Life [Срок оценки: From baseline to end of treatment (8 weeks) and 4-week follow-up.]
  • Change in Work Absenteeism [Срок оценки: From baseline to end of treatment (8 weeks) and 4-week follow-up.]

Критерии участия

Критерии включения

  • Have an active employment contract with Lacor Textil covering the entire duration of the study, including the month following the third evaluation phase.
  • Be aged 18-65 years (inclusive).
  • Be available to participate in all scheduled sessions.

Критерии исключения

  • Have severe or specific musculoskeletal conditions that contraindicate exercise.
  • Be currently pregnant.
  • Be receiving physiotherapy treatment concurrently.
  • Be on temporary sick leave during the intervention period.
  • Not have the physical capacity required to participate in the workshops and guided exercise.
  • Have cognitive or communication impairments that prevent adequate participation.
  • Complete less than 80% of the intervention program.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Lacor Textil — Zaragoza

Публикации

  • Jimenez-Sanchez C, Cordova-Alegre P, Sanjuan-Sanchez D, Ibiricu-Abendano G, Rabal-Pelay J, Piedrafita E. Impact of an exercise and health education program for health promotion in textile workers: a pre-post intervention study protocol. Front Public Health. 2026 Jun 2;14:1856664. doi: 10.3389/fpubh.2026.1856664. eCollection 2026. PMID 42311978

Идентификаторы

NCT: NCT07360626 · 7/1/25-26

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗