NCT02552680

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable quality-of-life

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

4.6 years

First QC Date

August 18, 2015

Last Update Submit

July 8, 2016

Conditions

Keywords

Work-Related Musculoskeletal DisordersQuality of lifeHealth Education

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    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 Outcomes (4)

  • Muscle strength - Grip and Pinch Strength

    4 weeks and 26 weeks after the interventions

  • Muscle flexibility

    4 weeks and 26 weeks after the interventions

  • Musculoskeletal intensity of pain

    4 weeks and 26 weeks after the interventions

  • Quality of life - after 4 weeks

    4 weeks after the interventions

Study Arms (2)

Exercise + guideline

EXPERIMENTAL

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.

Other: ExerciseOther: Guideline

brochure

ACTIVE COMPARATOR

Participants will receive a manual-brochure - containing information about general health.

Other: Brochure

Interventions

Physical Exercise

Exercise + guideline

Guideline on care and prevention of Work-Related Musculoskeletal Disorders in activities of daily living, especially those relating work activities.

Exercise + guideline

Manual/brochure containing information about general health

brochure

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health Education

Interventions

ExerciseGuidelines as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaQuality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Antônio C dos Santos, Doctorate

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2015

First Posted

September 17, 2015

Study Start

October 1, 2010

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

July 11, 2016

Record last verified: 2016-07