Health Chair: Exercise and Health Education Intervention at Profand Zaragoza
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in pain intensity assessed with the Numeric Rating Scale (NRS)
研究概览
简要总结
This prospective, non-randomised interventional study aims to assess changes in musculoskeletal health, pain and physical activity among industrial workers following a health education and exercise programme adapted to their baseline musculoskeletal profile.
Workers from production lines 8 and 9 at Profand Zaragoza will be allocated to one of two groups according to their baseline musculoskeletal symptoms, assessed using the Nordic Musculoskeletal Questionnaire. The reference group will receive a health education session, while workers with a higher baseline musculoskeletal burden will receive the same health education session together with a specific exercise programme consisting of supervised face-to-face and asynchronous home-based sessions.
The primary outcome is perceived pain intensity measured using the Numeric Rating Scale (NRS). Secondary outcomes include musculoskeletal symptoms and physical activity. In the specific intervention group, health-related quality of life and physical function will also be assessed. Outcomes will be evaluated at baseline, after the intervention and at three-month follow-up. Changes over time will be analysed separately within each group.
详细描述
Work-related musculoskeletal disorders are common among industrial workers and may be associated with repetitive movements, sustained postures, manual handling tasks and insufficient physical preparation for occupational demands. Workplace-based health education and exercise programmes may contribute to improving musculoskeletal health and promoting preventive behaviours.
This study will use a prospective, longitudinal, non-randomised interventional design in workers from production lines 8 and 9 at Profand Zaragoza. Participants will be assigned to one of two intervention groups according to their baseline musculoskeletal profile, assessed using the Nordic Musculoskeletal Questionnaire. Workers presenting a higher baseline musculoskeletal burden will be allocated to the specific intervention group, whereas workers who do not meet these criteria will be allocated to the reference group.
A higher baseline musculoskeletal burden will be defined by the presence of at least one of the following: musculoskeletal symptoms during the previous 12 months that limited or prevented usual or occupational activities in at least one body region; musculoskeletal symptoms during the previous 12 months in two or more body regions; or musculoskeletal symptoms during the previous 7 days in at least one body region accompanied by recurrent symptoms during the previous 12 months in the same region.
The study is designed to assess changes over time within each group rather than to compare the two groups directly. Participants will undergo assessments before the intervention, after completion of the intervention period and at three-month follow-up. The reference group will receive a health education intervention, whereas the specific intervention group will receive the same health education intervention together with a tailored exercise programme delivered through face-to-face and asynchronous home-based sessions. The exercise programme will be adapted according to participants' baseline physical characteristics, perceived difficulty and response to exercise.
Because allocation is based on baseline musculoskeletal characteristics rather than randomisation, the two groups will not be considered directly comparable. Statistical analyses will therefore focus on within-group changes across the assessment time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Current employment contract with Profand Zaragoza covering the full duration of study participation, including the follow-up period.
- •Age between 18 and 65 years, inclusive.
- •Availability to participate in the scheduled study sessions.
- •Written informed consent provided before enrolment.
排除标准
- •Uncontrolled musculoskeletal, neurological, cardiovascular, respiratory, or systemic disease that contraindicates physical exercise.
- •Acute musculoskeletal injury, recent surgery, or traumatic condition that substantially limits participation in the physical assessments or exercise programme.
- •Current pregnancy.
- •Temporary work incapacity due to illness during the intervention period.
- •Physical or functional limitation preventing the participant from performing physical exercise independently and safely, even after individual adaptation of the programme by the research team. If there is uncertainty regarding exercise safety, medical assessment will be recommended before inclusion.
- •Cognitive or communication impairment preventing the participant from understanding the study information, providing valid informed consent, or adequately following the instructions for the assessments and exercises.
研究组 & 干预措施
Reference Group
Participants without a higher baseline musculoskeletal burden according to the Nordic Musculoskeletal Questionnaire will receive one face-to-face health education session.
干预措施: Health Education (Behavioral)
Specific Intervention Group
Participants with a higher baseline musculoskeletal burden according to the Nordic Musculoskeletal Questionnaire will receive the same face-to-face health education session as the reference group, together with a tailored exercise programme consisting of 8 face-to-face and 8 asynchronous home-based exercise sessions.
干预措施: Tailored Exercise Programme (Behavioral)
结局指标
主要结局
Change in pain intensity assessed with the Numeric Rating Scale (NRS)
时间窗: Baseline, immediately after completion of the intervention period, and 3 months after the post-intervention assessment
Perceived general pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Changes from baseline will be assessed after the intervention and at follow-up.
次要结局
- Change in musculoskeletal symptoms assessed with the Nordic Musculoskeletal Questionnaire(Baseline, immediately after completion of the intervention period, and 3 months after the post-intervention assessment)
- Change in physical activity assessed with the International Physical Activity Questionnaire-Short Form (IPAQ-SF)(Baseline, immediately after completion of the intervention period, and 3 months after the post-intervention assessment)
- Change in health-related quality of life assessed with the EQ-5D-5L(Baseline (T0), at the end of the 8-week intervention period (T1), and 3 months after T1 (T2).)
- Change in handgrip strength measured with a hand dynamometer(Baseline (T0), at the end of the 8-week intervention period (T1), and 3 months after T1 (T2).)
- 30-Second Sit-to-Stand Test(Baseline (T0), at the end of the 8-week intervention period (T1), and 3 months after T1 (T2).)
- Change in neck flexor muscle endurance(Baseline (T0), at the end of the 8-week intervention period (T1), and 3 months after T1 (T2).)
- Change in shoulder flexibility assessed with the Back Scratch Test(Baseline (T0), at the end of the 8-week intervention period (T1), and 3 months after T1 (T2).)
- Trunk stability(Baseline (T0), at the end of the 8-week intervention period (T1), and 3 months after T1 (T2).)