跳至主要内容
临床试验/NCT07360626
NCT07360626
招募中
不适用

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

Universidad San Jorge1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2026年2月1日最近更新:

概览

阶段
不适用
状态
招募中
发起方
Universidad San Jorge
入组人数
38
试验地点
1
主要终点
Change in Pain Intensity

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Physical Exercise and Health Education Program

Experimental

Participants in this arm will receive an eight-week physical therapy and health education program. Exercise sessions will be held twice weekly for 20 minutes via the RehBody mobile app, focusing on mobility, strength, and stability of the upper and lower extremities. Participants will also attend weekly 45-minute in-person workshops covering pain management, coping strategies, self-efficacy, stress management, relaxation, sleep hygiene, and healthy habits.

干预措施: Combined Exercise Training and Health Education Program (Other)

结局指标

主要结局

Change in Pain Intensity

时间窗: From baseline to end of treatment (8 weeks) and 4-week follow-up.

Change in the score on the Numerical Rating Scale (NRS). The NRS scale for pain assessment is a scale that measures the intensity of pain experienced by the patient. It is a numerical rating scale where the patient is asked to rate their pain between 0 and 10. The reported values are classified as follows: no pain = 0; mild pain = 1,2; moderate pain = 3-5; severe pain = 6-8; unbearable pain = 9-10.

次要结局

  • Change in Musculoskeletal Symptoms(From baseline to end of treatment (8 weeks) and 4-week follow-up.)
  • Change in Upper Limb Muscle Strength(From baseline to end of treatment (8 weeks) and 4-week follow-up.)
  • Change in Lower Limb Muscle Strength(From baseline to end of treatment (8 weeks) and 4-week follow-up.)
  • Change in Physical Activity Level(From baseline to end of treatment (8 weeks) and 4-week follow-up.)
  • Change in Work Ability(From baseline to end of treatment (8 weeks) and 4-week follow-up.)
  • Sleep Quality(From baseline to end of treatment (8 weeks) and 4-week follow-up.)
  • Changes in Depression, Anxiety and Stress(From baseline to end of treatment (8 weeks) and 4-week follow-up.)
  • Change in Quality of Life(From baseline to end of treatment (8 weeks) and 4-week follow-up.)
  • Change in Work Absenteeism(From baseline to end of treatment (8 weeks) and 4-week follow-up.)

研究者

发起方
Universidad San Jorge
申办方类型
Other
责任方
Sponsor

研究点 (1)

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