- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07417527
Active Pauses for Musculoskeletal Disorder Prevention in Workers
Prevention Program for Musculoskeletal Disorders Through Active Pauses for Workers in the Basque Country
The goal of this clinical trial is to learn if short exercise breaks at work can prevent muscle and joint pain in workers. The main questions it aims to answer are:
Do strength exercises help workers move better and feel less pain?
Are strength exercises better than stretching exercises for worker health?
Researchers will compare a strength exercise program to a mobility (stretching) program to see which one works better to improve physical health and work ability.
Participants will:
Perform short exercise breaks (5 minutes) at their workplace every day for 8 weeks.
Attend one supervised session per week to learn the exercises.
Complete simple physical tests (like standing up from a chair) and answer surveys about their health at the start and end of the study.
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a quasi-experimental study with parallel assignment. The study evaluates the effectiveness of active pauses (brief workplace exercise interventions) preventing musculoskeletal disorders. Recruitment and intervention are conducted in collaboration with "Recuperación Funcional Gurea S.Coop.Peq" at various companies in the Basque Country.
Group Allocation:
Participants are assigned to one of two groups based on their work center or worker preference to maximize participation and adherence in a real-world setting.
Interventions:
Both groups follow an 8-week program consisting of daily 5-minute sessions.
Experimental Arm (Strength): Participants perform high-intensity interval training based on resistance exercises. It involves 4 specific exercises targeting the shoulder, back, and legs using elastic bands or body weight. The intensity is monitored to reach a high level of effort.
Active Comparator Arm (Mobility): Participants perform a standard routine of 12 mobility and static stretching exercises. These are low-intensity movements designed to mobilize joints and relax muscles without inducing fatigue.
Assessments:
The Principal Investigator conducts assessments at three time points:
Baseline (Week 0): Before starting the program.
Post-Intervention (Week 8): Immediately after the 8-week program.
Follow-up (Week 20): 3 months after the intervention ends.
Outcomes:
The study measures functional capacity (30-second Sit-to-Stand test), isometric strength (handgrip and shoulder), and self-reported health using the "Senior Working Life Questionnaire" (pain intensity, work ability, and vitality).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Iñigo Perez Garcia, PT
- Phone Number: +34 946 01 35 11
- Email: iperez197@ikasle.ehu.eus
Study Locations
-
-
Biscay
-
Leioa, Biscay, Spain, 48940
- Recruiting
- Universidad del País Vasco (UPV/EHU)
-
Contact:
- Iñigo Perez Garcia, PT
- Phone Number: +34 946 01 35 11
- Email: iperez197@ikasle.ehu.eus
-
Sub-Investigator:
- Juan José Torres Unda
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Active workers.
- Aged 18 years or older.
- Capability to perform vigorous physical exercise.
Exclusion Criteria:
- Medical contraindications to physical exercise.
- Recent surgery.
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Strength Training Program
Participants perform a strength-based active pause program (5 minutes).
It consists of 4 exercises using body weight and elastic bands targeting shoulder, back, and legs. 1 supervised session/week plus daily autonomous practice for 8 weeks
|
High-intensity interval training protocol using resistance exercises (elastic bands) performed at the workplace.
|
|
Active Comparator: Active Comparator: Mobility and Stretching Program
Participants perform a traditional mobility and stretching active pause program (5 minutes).
It consists of 12 low-intensity exercises mobilizing main joints. 1 supervised session/week plus daily autonomous practice for 8 weeks.
|
Standard routine of articular mobility and static stretching exercises performed at the workplace.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-Second Sit-to-Stand Test
Time Frame: Baseline (Week 0), Post-intervention (Week 8), and Follow-up (Week 20).
|
Participants must stand up and sit down as many times as possible from a chair during a 30-second period to assess lower body functional strength.
|
Baseline (Week 0), Post-intervention (Week 8), and Follow-up (Week 20).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Handgrip Strength
Time Frame: Baseline (Week 0), Post-intervention (Week 8), and Follow-up (Week 20)
|
Maximum force measured in kilograms using a manual dynamometer
|
Baseline (Week 0), Post-intervention (Week 8), and Follow-up (Week 20)
|
|
Shoulder Abduction Strength
Time Frame: Baseline (Week 0), Post-intervention (Week 8), and Follow-up (Week 20)
|
Maximum isometric strength measured with a dynamometer while performing shoulder abduction at 90 degrees
|
Baseline (Week 0), Post-intervention (Week 8), and Follow-up (Week 20)
|
|
Intervention Adherence
Time Frame: Throughout the 8-week intervention period
|
Number of active pause sessions completed by the participant, recorded daily in a tracking sheet
|
Throughout the 8-week intervention period
|
|
Senior Working Life Questionnaire
Time Frame: Baseline (Week 0), Post-intervention (Week 8), and Follow-up (Week 20)
|
A 24-item questionnaire assessing seven areas: sociodemographics, life and work satisfaction, physical activity at work, health and work ability, and musculoskeletal pain.
Scores range from 0 to 100, where higher scores indicate a better outcome.
|
Baseline (Week 0), Post-intervention (Week 8), and Follow-up (Week 20)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M10_2025_322
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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