- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore attivo: brochure
Participants will receive a manual-brochure - containing information about general health.
|
Manual/brochure containing information about general health
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Quality of life
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Muscle strength - Grip and Pinch Strength
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Antônio C dos Santos, Doctorate, Federal University of Rio Grande do Sul
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GPPG100432
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .