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Musculoskeletal Disorders (MSDs)LACOR-HEALTHNCT07360626

Exercise and Health Education for Textile Workers: A Pre-Post Study

A study testing Combined Exercise Training and Health Education Program in people with Musculoskeletal Disorders (MSDs) and Musculoskeletal Diseases or Conditions, run by Universidad San Jorge at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Combined Exercise Training and Health Education Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSpain
Study dates
1 Feb 2026to 10 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

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

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Lacor Textil

    Zaragoza, Aragon, 50197

Other trials in Spain

About this study

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

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.

Read more

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.

Read the detailed description

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.

Being tested
Combined Exercise Training and Health Education Program
Keywords
Textile workers, Exercise program, Health education, Pre-post intervention
Medical subject headings
Musculoskeletal Diseases, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined Exercise Training and Health Education ProgramOther

    The intervention consists of an 8-week hybrid program combining exercise training and workplace-based health education. Eight on-site educational workshops (one per week) are delivered during working hours and address topics related to pain management, physical activity, stress management, and healthy lifestyle behaviors, including review and discussion sessions.

    The exercise training includes two weekly sessions delivered through a mobile application (RehBody platform). Sessions begin with a warm-up incorporating mobility and core exercises, followed by strengthening exercises for the upper and lower extremities. Exercise difficulty progresses from bilateral, single-joint movements to unilateral, multi-joint exercises. The program is delivered by trained physical therapists and is adaptable to individual participant needs.

Study groups in NCT07360626
Study groupRoleWhat they receive
Physical Exercise and Health Education ProgramExperimentalParticipants 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.
Receives: Other: Combined Exercise Training and Health Education Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pain Intensity

    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.

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

Secondary outcomes (9)
  1. Change in Musculoskeletal Symptoms

    Musculoskeletal disorders will be evaluated using the Standardized Nordic Musculoskeletal Questionnaire (Kuorinka), a self-administered questionnaire consisting of 11 multiple-choice items. The questionnaire provides information on the presence of pain, fatigue, or discomfort in different musculoskeletal body regions. It is designed to detect early musculoskeletal symptoms and to support the analysis of potential ergonomic risk factors. Higher values indicate a greater burden of musculoskeletal symptoms.

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

  2. Change in Upper Limb Muscle Strength

    Upper limb muscle strength will be assessed using the handgrip strength test, measured with a hand-held dynamometer (Takei Grip-D). Participants will be seated on a chair with the elbow flexed at 90 degrees and the forearm in a neutral position. Participants will perform a maximal handgrip contraction for up to 3 seconds. Three trials will be conducted, with a 1-minute rest period between attempts. Handgrip strength will be recorded in kilograms (kg), with higher values indicating greater upper limb muscle strength.

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

  3. Change in Lower Limb Muscle Strength

    Lower limb muscle strength will be measured using the 30-second Sit-to-Stand-Test (STST).Participants will begin seated on a chair with feet slightly apart and flat on the floor, and arms crossed over the chest. Upon a verbal signal, participants will rise to a full standing position and return to the seated position as many times as possible within 30 seconds. Only correctly completed repetitions, as well as repetitions reaching more than half of the full range of motion at the end of the test, will be counted. Higher numbers of repetitions indicate greater lower limb muscle strength.

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

  4. Change in Physical Activity Level

    Physical Activity level will be assessed using the International Physical Activity Questionnaire, Short Form (IPAQ-SF), a validated self-administered questionnaire consisting of 7 items. The questionnaire records the frequency (days per week) and duration (hours and minutes per day) of physical activity performed during a reference week. It is a standardized instrument widely used internationally for population-based physical activity assessment. Higher scores indicate higher levels of physical activity.

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

  5. Change in Work Ability

    Work ability will be measured with the Work Ability Index (WAI). The WAI is a self-reporter questionnaire based on the worker's self-perception of their capacity to perform work tasks in relation to job demands and current health status. It includes eleven questions grouped into seven dimensions and generates an overall score reflecting current work ability, as well as an estimation of work ability over the following two years. Higher scores represent better perceived work ability.

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

  6. Sleep Quality

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-administered questionnaire measuring multiple aspects of sleep, including sleep quality, latency, duration, efficiency, disturbances, and daytime dysfunction. Each item is scored to contribute to a global score ranging from 0 to 21, where 0 indicates no sleep difficulties and 21 indicates severe sleep problems. Higher scores reflect poorer sleep quality.

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

  7. Changes in Depression, Anxiety and Stress

    Depression, anxiety and stress will be measured with the Depression, Anxiety and Stress Scale (DASS-21). In this scale, each item is answered according to the intensity of each symptom suffered in the last week on a Likert scale from 0 to 3 points. The global scale contains three different blocks for: depression, anxiety and stress. Each block has seven items. The global scale score ranges from 0 to 21 points. In the Depression, Anxiety and Stress Scale, higher scores indicate higher levels of stress, depression and anxiety.

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

  8. Change in Quality of Life

    Change in health-related quality of life will be assessed using the EuroQol 5-Dimension 3-Level questionnaire (EQ-5D-3L), Spanish version. The EQ-5D-3L is a validated instrument that can be self-administered or administered via interview to assess health-related quality of life across multiple dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The questionnaire comprises five items, each with three response levels (no problems = 1, some problems = 2, extreme problems = 3). Responses are coded and weighted to generate an index value. Additionally, the EQ-5D-3L includes a 20-centimeter vertical visual analogue scale (VAS) ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), on which participants rate their current perceived health status. Higher scores indicate better health-related quality of life.

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

  9. Change in Work Absenteeism

    Work absenteeism will be evaluated using the Work Productivity and Activity Impairment Questionnaire (WPAI), a validated self-administered instrument that measures the impact of health problems on work productivity. The absenteeism domain assesses the percentage of work time missed due to health-related reasons during the previous 7 days. Higher percentages indicate greater work absenteeism.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start1 Feb 2026
  3. Primary completion1 Jun 2026
  4. Study completion10 Jul 2026

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07360626
Sponsor's protocol ID
7/1/25-26
Acronym
LACOR-HEALTH
Status last verified
Sep 2026
First submitted
13 Jan 2026
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared with other researchers beyond what is included in scientific publications derived from this study. Data sharing is limited to aggregated results presented in peer-reviewed articles to ensure participant confidentiality and comply with data protection regulations.

Publications

  • Jimenez-Sanchez C, Cordova-Alegre P, Sanjuan-Sanchez D, Ibiricu-Abendano G, Rabal-Pelay J, Piedrafita E. Impact of an exercise and health education program for health promotion in textile workers: a pre-post intervention study protocol. Front Public Health. 2026 Jun 2;14:1856664. doi: 10.3389/fpubh.2026.1856664. eCollection 2026.

    PubMed 42311978

Questions about this trial

What is this clinical trial studying?

A study testing Combined Exercise Training and Health Education Program in people with Musculoskeletal Disorders (MSDs) and Musculoskeletal Diseases or Conditions, 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 16 Sep 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Intensity (time frame: From baseline to end of treatment (8 weeks) and 4-week follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07360626, which also lists 1 linked publication.

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 16 Sep 2026.

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