Preventive Program for Work-Related Musculoskeletal Disorders
Primary Purpose
Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Guideline
Brochure
Sponsored by
About this trial
This is an interventional prevention trial for Quality of Life focused on measuring Work-Related Musculoskeletal Disorders, Quality of life, Health Education
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise + guideline
brochure
Arm Description
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.
Participants will receive a manual-brochure - containing information about general health.
Outcomes
Primary Outcome Measures
Quality of life
Quality of life evaluated by the Short-Form Survey Questionnaire (SF-36). Unit of measure: Scale of Quality of life.
Secondary Outcome Measures
Muscle strength - Grip and Pinch Strength
Evaluated by hand grip dynamometer and pinch grip dynamometer. Unit of measure: kilogram force (kgf) (both evaluations).
Muscle flexibility
Evaluated by "Banco de Wells". Unit of measure: centimeters (cm)
Musculoskeletal intensity of pain
Evaluated by Questionnaire. Unit of measure: Scale of pain.
Quality of life - after 4 weeks
Quality of life evaluated by the Short-Form Survey Questionnaire (SF-36). Unit of measure: Scale of Quality of life.
Full Information
NCT ID
NCT02552680
First Posted
August 18, 2015
Last Updated
July 8, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02552680
Brief Title
Preventive Program for Work-Related Musculoskeletal Disorders
Official Title
Influence of a Preventive Program (Educational and Gymnastics) for Work-Related Musculoskeletal Disorders in Surgeons
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life
Keywords
Work-Related Musculoskeletal Disorders, Quality of life, Health Education
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise + guideline
Arm Type
Experimental
Arm Description
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.
Arm Title
brochure
Arm Type
Active Comparator
Arm Description
Participants will receive a manual-brochure - containing information about general health.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Physical Exercise
Intervention Type
Other
Intervention Name(s)
Guideline
Intervention Description
Guideline on care and prevention of Work-Related Musculoskeletal Disorders in activities of daily living, especially those relating work activities.
Intervention Type
Other
Intervention Name(s)
Brochure
Intervention Description
Manual/brochure containing information about general health
Primary Outcome Measure Information:
Title
Quality of life
Description
Quality of life evaluated by the Short-Form Survey Questionnaire (SF-36). Unit of measure: Scale of Quality of life.
Time Frame
26 weeks after the interventions
Secondary Outcome Measure Information:
Title
Muscle strength - Grip and Pinch Strength
Description
Evaluated by hand grip dynamometer and pinch grip dynamometer. Unit of measure: kilogram force (kgf) (both evaluations).
Time Frame
4 weeks and 26 weeks after the interventions
Title
Muscle flexibility
Description
Evaluated by "Banco de Wells". Unit of measure: centimeters (cm)
Time Frame
4 weeks and 26 weeks after the interventions
Title
Musculoskeletal intensity of pain
Description
Evaluated by Questionnaire. Unit of measure: Scale of pain.
Time Frame
4 weeks and 26 weeks after the interventions
Title
Quality of life - after 4 weeks
Description
Quality of life evaluated by the Short-Form Survey Questionnaire (SF-36). Unit of measure: Scale of Quality of life.
Time Frame
4 weeks after the interventions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antônio C dos Santos, Doctorate
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Preventive Program for Work-Related Musculoskeletal Disorders
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