- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Aktiv komparator: brochure
Participants will receive a manual-brochure - containing information about general health.
|
Manual/brochure containing information about general health
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of life
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Muscle strength - Grip and Pinch Strength
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Antônio C dos Santos, Doctorate, Federal University of Rio Grande do Sul
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GPPG100432
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .