An interventional study of Health Education and Tailored Exercise Programme in Work-Related Musculoskeletal Disorders, sponsored by Universidad San Jorge. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Universidad San Jorge · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Participants without a higher baseline musculoskeletal burden according to the Nordic Musculoskeletal Questionnaire will receive one face-to-face health education session.
Behavioral: Health Education
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.
Behavioral: Tailored Exercise Programme
One face-to-face health education session covering pain and coping/self-efficacy strategies, strength exercise, aerobic exercise, mobility, active breaks, sleep hygiene and healthy habits, stress management and emotional well-being, adherence and motivation, and a final discussion and review.
Participants will receive the same face-to-face health education session as the reference group, covering pain and coping/self-efficacy strategies, strength and aerobic exercise, mobility, active breaks, sleep hygiene and healthy habits, stress management and emotional well-being, adherence and motivation. In addition, participants will complete a tailored exercise programme consisting of 8 supervised face-to-face exercise sessions and 8 asynchronous home-based exercise session, corresponding to one face-to-face and one home-based session per week. Exercises will focus on general mobility and stability of the neck, wrist/hand, shoulder and thoracolumbar spine, as well as strengthening of the upper and lower limbs. Exercise difficulty and repetitions may be individually adapted according to each participant's response, perceived difficulty and tolerance. The home-based session will be delivered asynchronously through the RehBody digital platform.
Change in pain intensity assessed with the Numeric Rating Scale (NRS)
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.
Time frame: Baseline, immediately after completion of the intervention period, and 3 months after the post-intervention assessment
Change in musculoskeletal symptoms assessed with the Nordic Musculoskeletal Questionnaire
Musculoskeletal symptoms will be assessed using the Nordic Musculoskeletal Questionnaire. This self-administered questionnaire identifies the presence of musculoskeletal symptoms in nine body regions: neck, shoulders, upper back, lower back, elbows, wrists/hands, hips/thighs, knees, and ankles/feet. Changes in reported musculoskeletal symptoms will be assessed over time.
Time frame: 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)
Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), a 7-item self-administered questionnaire that records the frequency and duration of physical activity performed during the previous 7 days.
Time frame: 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
Health-related quality of life will be assessed using the EQ-5D-5L. This outcome will be assessed only in participants allocated to the specific intervention group. The questionnaire evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and provides a health utility index. It also includes a visual analogue scale ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 the best imaginable health state.
Time frame: 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
Handgrip strength will be assessed only in participants allocated to the specific intervention group using a Takei Grip-D hand dynamometer. Participants will perform the test while seated, with the elbow flexed to 90 degrees and the forearm in a neutral position. Three maximal handgrip attempts lasting up to 3 seconds will be performed, with 1 minute of rest between attempts.
Time frame: Baseline (T0), at the end of the 8-week intervention period (T1), and 3 months after T1 (T2).
30-Second Sit-to-Stand Test
Lower-limb functional strength will be assessed only in participants allocated to the Specific Intervention Group using the 30-Second Sit-to-Stand Test. Participants will start seated on a chair with their feet slightly apart and their arms crossed over the chest and will repeatedly stand up and sit down for 30 seconds. The number of correctly completed repetitions will be recorded, with a higher number of repetitions indicating better performance.
Time frame: Baseline (T0), at the end of the 8-week intervention period (T1), and 3 months after T1 (T2).
Change in neck flexor muscle endurance
Neck flexor muscle endurance will be assessed only in participants allocated to the specific intervention group. Participants will lie in a supine position, raise the head and neck without lifting the shoulders from the surface, and maintain the position for as long as possible. The duration for which the position can be maintained without resting the head will be recorded in seconds, with a longer duration indicating greater endurance.
Time frame: 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
Shoulder flexibility will be assessed only in participants allocated to the Specific Intervention Group using the Back Scratch Test. The distance between the middle fingers will be measured in centimetres while one arm reaches over the shoulder and the other reaches upwards from the lower back. A positive value will indicate overlap of the fingers, whereas a negative value will indicate a gap between the fingers. The test will be performed in both directions.
Time frame: Baseline (T0), at the end of the 8-week intervention period (T1), and 3 months after T1 (T2).
Trunk stability
Trunk stability will be assessed only in participants allocated to the Specific Intervention Group. From a prone position with the chest supported, participants will attempt to raise the body into a plank position in a single movement while maintaining trunk alignment. Performance will be recorded according to the hand position used (forehead, chin, or shoulders) and whether the movement is correctly completed (yes/no). The number of attempts will also be recorded. No numerical score will be assigned.
Time frame: Baseline (T0), at the end of the 8-week intervention period (T1), and 3 months after T1 (T2).
Plan to share: No — Individual participant data will not be shared with other researchers. Only aggregated and anonymised study results will be reported, with no disclosure of individual-level data or participant codes, in order to protect participant confidentiality.
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