Exercise and Health Education for Musculoskeletal Health in Industrial Workers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversidad San Jorge
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Health Education
BehavioralOne 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.
Tailored Exercise Programme
BehavioralParticipants 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.
Treatment groups
33 Participants
are divided into 2 treatment groupsGroup A: Reference GroupExperimental treatment 1 intervention
Group B: Specific Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 assessmentSecondary outcomes
1
Change in musculoskeletal symptoms assessed with the Nordic Musculoskeletal Questionnaire
Musculoskeletal symptoms will be assessed using the Nordic Musculoskeletal Questionnaire. The questionnaire records the presence or absence of musculoskeletal symptoms in nine body regions: neck, shoulders, upper back, lower back, elbows, wrists/hands, hips/thighs, knees, and ankles/feet. For each body region, symptoms are recorded as a dichotomous response (Yes/No). This questionnaire does not provide a single overall scale score. Changes over time in the presence of musculoskeletal symptoms in each body region will be assessed, with the presence of symptoms representing a worse outcome.
Time frame
Baseline, immediately after completion of the intervention period, and 3 months after the post-intervention assessment2
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 walking, moderate-intensity physical activity, and vigorous-intensity physical activity performed during the previous 7 days. Physical activity is expressed as metabolic equivalent task minutes per week (MET-min/week). Total physical activity is calculated by summing the MET-min/week obtained from walking, moderate-intensity activity, and vigorous-intensity activity. The minimum possible value is 0 MET-min/week. The questionnaire does not have a fixed maximum score. Higher values indicate a greater level of physical activity and therefore a be
Time frame
Baseline, immediately after completion of the intervention period, and 3 months after the post-intervention assessment3
Change in health-related quality of life assessed with the EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (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).4
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).Sponsors and contacts
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Source ClinicalTrials.gov