- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02552680
Preventive Program for Work-Related Musculoskeletal Disorders
Influence of a Preventive Program (Educational and Gymnastics) for Work-Related Musculoskeletal Disorders in Surgeons
Introduction: Work-Related Musculoskeletal Disorders (WMSDs) are characterized by inflammation of muscles, tendons, fascia and nerves of upper limbs, shoulder girdle and neck. Its incidence is increasing and there is evidence of its association with the pace of work. As WMSDs, another major public health problem is back pain, which also negatively influence the quality of life of patients. These diseases affect many workers, among them, workers in the health area, including surgeons. Studies show that many surgeons are suffering from fatigue and musculoskeletal pain after undergoing surgery, especially laparoscopy. Regarding the quality of life of doctors, a study indicates that surgeons have commitment of domains "Vitality" and "Pain". For these reasons it is important to develop strategies for prevention of occupational risks (WMSDs) in this class of workers.
Objectives: To evaluate the influence of a Preventive Program (educational and gymnastics) for prevention of WMSDs, in the quality of life, in limitation of the work, in intensity and frequency of musculoskeletal pain in surgeons of the Hospital de Clínicas de Porto Alegre. There will also be evaluated the effects of the program on muscular strength and flexibility of medics participating in the Preventive Program.
Methodology: Randomized clinical trial with a sample of 54 surgeons, divided into two groups: A ("Intervention": will participate in eight meetings consisting of exercise and guidelines on care and prevention of WMSDs in activities of daily living, especially those relating work activities) and B ("Control": will receive a manual-brochure - containing information about general health). Participants will sign a Letter of Consent.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Clinical Trial Study with 54 surgeons allocated in two groups: A and B. They received two protocols in accordance with the groups they have been allocated.
Group A: participated in eight meetings supervised by physical education professionals, with 15 minutes duration, individually administered, twice a week, during the surgeons working hours, at times and places combined with them. The meetings were composed of endurance exercise, mobility and muscle stretching. They were also given guidance on care and prevention of Work-Related Musculoskeletal Disorders in activities fo daily life, especially those related to work activities.
Group B: received a manual (brochure ) containing information on general health care, especially designed for this study. With food guide, sleep, physical activity and smoking.
Were measured the quality of life, muscle force, muscle stretching and pain. The dates were collected at the beginning of the procedures, 4 weeks after the protocols and 26 after the protocols.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- surgeons (teachers, contractors and medical residents)
- of the Hospital de Clínicas de Porto Alegre
- members of General Surgery teams, Digestive Surgery , Plastic Surgery and Coloproctology
- of both sexes
Exclusion Criteria:
- individuals who did not agree to participate in the study
- those who were not present at the time of the study (regardless of reason)
- those who had some more serious illness that prevented the achievement of study protocols
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise + guideline
Participants will participate in eight meetings consisting of exercise and guidelines on care and prevention of Work-Related Musculoskeletal Disorders in activities of daily living, especially those relating work activities.
|
Physical Exercise
Guideline on care and prevention of Work-Related Musculoskeletal Disorders in activities of daily living, especially those relating work activities.
|
|
Active Comparator: brochure
Participants will receive a manual-brochure - containing information about general health.
|
Manual/brochure containing information about general health
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life
Time Frame: 26 weeks after the interventions
|
Quality of life evaluated by the Short-Form Survey Questionnaire (SF-36).
Unit of measure: Scale of Quality of life.
|
26 weeks after the interventions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle strength - Grip and Pinch Strength
Time Frame: 4 weeks and 26 weeks after the interventions
|
Evaluated by hand grip dynamometer and pinch grip dynamometer.
Unit of measure: kilogram force (kgf) (both evaluations).
|
4 weeks and 26 weeks after the interventions
|
|
Muscle flexibility
Time Frame: 4 weeks and 26 weeks after the interventions
|
Evaluated by "Banco de Wells".
Unit of measure: centimeters (cm)
|
4 weeks and 26 weeks after the interventions
|
|
Musculoskeletal intensity of pain
Time Frame: 4 weeks and 26 weeks after the interventions
|
Evaluated by Questionnaire.
Unit of measure: Scale of pain.
|
4 weeks and 26 weeks after the interventions
|
|
Quality of life - after 4 weeks
Time Frame: 4 weeks after the interventions
|
Quality of life evaluated by the Short-Form Survey Questionnaire (SF-36).
Unit of measure: Scale of Quality of life.
|
4 weeks after the interventions
|
Collaborators and Investigators
Investigators
- Principal Investigator: Antônio C dos Santos, Doctorate, Federal University of Rio Grande do Sul
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GPPG100432
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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