NCT07360626

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Feb 2026Jun 2026

First Submitted

Initial submission to the registry

January 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

January 13, 2026

Last Update Submit

April 10, 2026

Conditions

Musculoskeletal Disorders (MSDs)Musculoskeletal Diseases or Conditions

Keywords

Textile workersExercise programHealth educationPre-post intervention

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

  • Change in Musculoskeletal Symptoms

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

  • Change in Upper Limb Muscle Strength

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

  • Change in Lower Limb Muscle Strength

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

  • Change in Physical Activity Level

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

  • Change in Work Ability

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

  • +4 more secondary outcomes

Study Arms (1)

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.

Other: Combined Exercise Training and Health Education Program

Interventions

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.

Physical Exercise and Health Education Program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lacor Textil

Zaragoza, Aragon, 50197, Spain

RECRUITING

MeSH Terms

Conditions

Musculoskeletal DiseasesHealth Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Carolina Jimenez Sanchez, PhD

CONTACT

+0034649612644cjimenez@usj.es

Eduardo Piedrafita Trigo, PhD

CONTACT

epiedrafita@usj.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 22, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

ES(1)