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.
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
- Conditions the study is for
- Musculoskeletal Disorders (MSDs), Musculoskeletal Diseases or Conditions
- 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.
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 group | Role | What they receive |
|---|---|---|
| Physical Exercise and Health Education Program | Experimental | Participants 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.
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
- First posted22 Jan 2026
- Study start1 Feb 2026
- Primary completion1 Jun 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal Disorders (MSDs)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Exercise and Health Education Program for Health Promotion in Textile Workers: A Pre-Post Intervention Study
- ClinicalTrials.gov ID
- NCT07360626
- Acronym / sponsor ID
- LACOR-HEALTH / 7/1/25-26
- Keywords
- Textile workers, Exercise program, Health education, Pre-post intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 22 Jan 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.
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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Exercise and Health Education Program | Experimental | Other: Combined Exercise Training and Health Education ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Combined Exercise Training and Health Education ProgramThe 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. | Other | Physical Exercise and Health Education Program |
Primary outcome
Change in Pain Intensity
Time frame: From baseline to end of treatment (8 weeks) and 4-week follow-up.
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.
9 secondary outcomes
Change in Musculoskeletal Symptoms
Time frame: From baseline to end of treatment (8 weeks) and 4-week follow-up.
Change in Upper Limb Muscle Strength
Time frame: From baseline to end of treatment (8 weeks) and 4-week follow-up.
Change in Lower Limb Muscle Strength
Time frame: From baseline to end of treatment (8 weeks) and 4-week follow-up.
Change in Physical Activity Level
Time frame: From baseline to end of treatment (8 weeks) and 4-week follow-up.
Change in Work Ability
Time frame: From baseline to end of treatment (8 weeks) and 4-week follow-up.
Sleep Quality
Time frame: From baseline to end of treatment (8 weeks) and 4-week follow-up.
Changes in Depression, Anxiety and Stress
Time frame: From baseline to end of treatment (8 weeks) and 4-week follow-up.
Change in Quality of Life
Time frame: From baseline to end of treatment (8 weeks) and 4-week follow-up.
Change in Work Absenteeism
Time frame: From baseline to end of treatment (8 weeks) and 4-week follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Derived from this study: PubMed 42311978Jimenez-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.
- Individual participant dataSharing planned: 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.