Work-Related Musculoskeletal DisordersNCT07844707
Exercise and Health Education for Musculoskeletal Health in Industrial Workers
A study testing Health Education and Tailored Exercise Programme in people with Work-Related Musculoskeletal Disorders, run by Universidad San Jorge at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Work-Related Musculoskeletal Disorders
- What is being tested?
- Health Education and Tailored Exercise Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 22 Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Profand Zaragoza. Bari, 3
Zaragoza, Zaragoza, 50197
Natalia Brandín de la Cruz, PhD, +34 620 402 088, nbrandin@usj.es
Natalia Brandín de la Cruz, PhD
About this study
Official title: Health Chair: Exercise and Health Education Intervention at Profand Zaragoza
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.
Read the detailed description
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.
- Conditions
- Work-Related Musculoskeletal Disorders
- Being tested
- Health Education, Tailored Exercise Programme
- Keywords
- Workplace Exercise, Health Education, Industrial Workers, Physical Activity, Therapeutic Exercise, Workplace Health Promotion, Musculoskeletal pain, Musculoskeletal disorder
- Medical subject headings
- Health Education, Motor Activity, Musculoskeletal Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationBehavioural
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.
Tailored Exercise ProgrammeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Reference Group | Experimental | Participants without a higher baseline musculoskeletal burden according to the Nordic Musculoskeletal Questionnaire will receive one face-to-face health education session. Receives: Behavioral: Health Education |
| Specific Intervention Group | Experimental | 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. Receives: Behavioral: Tailored Exercise Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after completion of the intervention period, and 3 months after the post-intervention assessment
Secondary outcomes (8)
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.
Measured: 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 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
Measured: 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0), at the end of the 8-week intervention period (T1), and 3 months after T1 (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start22 Sep 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work-Related Musculoskeletal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be non-randomly assigned to one of two parallel intervention groups according to their baseline musculoskeletal profile assessed using the Nordic Musculoskeletal Questionnaire. The groups will be analysed independently, with no direct between-group comparisons.
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844707
- Sponsor's protocol ID
- PROFAND-2026-02
- Other IDs
- 2425002
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Chair: Exercise and Health Education Intervention at Profand Zaragoza
- ClinicalTrials.gov ID
- NCT07844707
- Acronym / sponsor ID
- PROFAND-2026-02
- Conditions
- Work-Related Musculoskeletal Disorders
- Keywords
- Workplace Exercise, Health Education, Industrial Workers, Physical Activity, Therapeutic Exercise, Workplace Health Promotion, Musculoskeletal pain, Musculoskeletal disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be non-randomly assigned to one of two parallel intervention groups according to their baseline musculoskeletal profile assessed using the Nordic Musculoskeletal Questionnaire. The groups will be analysed independently, with no direct between-group comparisons.
| Arm | Type | Receives |
|---|---|---|
| Reference Group | Experimental | Behavioral: Health EducationParticipants without a higher baseline musculoskeletal burden according to the Nordic Musculoskeletal Questionnaire will receive one face-to-face health education session. |
| Specific Intervention Group | Experimental | Behavioral: Tailored Exercise ProgrammeParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health EducationOne 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. | Behavioural | Reference Group |
| Tailored Exercise ProgrammeParticipants 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. | Behavioural | Specific Intervention Group |
Primary outcome
Change in pain intensity assessed with the Numeric Rating Scale (NRS)
Time frame: 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.
8 secondary outcomes
Change in musculoskeletal symptoms assessed with the Nordic Musculoskeletal Questionnaire
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)
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 EuroQol 5-Dimension 5-Level (EQ-5D-5L)
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
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
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
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
Time frame: Baseline (T0), at the end of the 8-week intervention period (T1), and 3 months after T1 (T2).
Trunk stability
Time frame: Baseline (T0), at the end of the 8-week intervention period (T1), and 3 months after T1 (T2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education and Tailored Exercise Programme in people with Work-Related Musculoskeletal Disorders, run by Universidad San Jorge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity assessed with the Numeric Rating Scale (NRS) (time frame: Baseline, immediately after completion of the intervention period, and 3 months after the post-intervention assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.