Project Arthritis Recovering Quality of Life by Means Education II (PARQVE II)

NCT02335034 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2020-06-09

No results posted yet for this study

Summary

OBJECTIVE: To evaluate the improvement of patients with gonarthritis exposed to a multidisciplinary care program with and without associated classroom educational program. METHODS: 152 patients (men and women) aged 40 or older with arthritis stages I to III of Kelgren and Lawrence. Have been treated with drugs, orthotics and referred to physical rehabilitation (physiotherapy and/or physical activity). Patients will be randomized into 2 groups of 76 and will go through pre-assessment with multidisciplinary team: Psychologist - assess cognitive ability; level of anxiety, and depression. Nutritionist - anthropometric parameters and diet quality. Social Worker - Level of education, religion, autonomy and mobility capacity to the hospital. Physiotherapist - range of motion, pain, function and quality of life. Occupational Therapy - range of motion and strength. Physical Educator - level of physical activity and functional capacity. Orthopaedic - additional examinations, disease classification, orthotics, report to Social Security and Traffic Department, evaluation questionnaires (SF 36, VAS, WOMAC, LEQUESNE), referral to physical therapy, physical activity and inform consent. A group will submitted to two interventions, with an interval of two months between each intervention. The control group will only make evaluations / consultations with all professional teams without classes for 2 years, then will attend the courses and will be followed by two more years. Interventions will be lectures and practices with the seven professional teams, covering the topic arthritis (orthopedic team), what is disease, being ill, and the role of the patient in the treatment (psychology) to obtain behavioral change. Lectures and practices with physical therapy and occupational therapy to show the importance of exercise in relieving symptoms (physical therapy), the importance of rest and proper ergonomics at home and at work (occupational therapy). The nutritionist shows proper alimentation. Lecture and practice with physical educator (showing the difference between the laber work and regular physical activity as well as the importance of strength exercises, resistance and stretching) and theoretical class with the social service by calling attention to the importance of leisure. After two months, the second intervention is made in order to verify the acquired concepts. Six months, 1, 2, 3 and 4 years after the first evaluation, the groups will be called to new multi evaluation.

Conditions

Interventions

BEHAVIORAL

Study Group Educational courses, DVD, print material of lectures

2 Educational courses (two months apart). Receive DVD and printed material of the lectures.

BEHAVIORAL

Control Group only make evaluations / consultations with all professional teams

Evaluations and consultations with all professional teams without classes for 2 years. At two years: two days of lectures two months apart with DVD and printed material of the lectures. Will be followed by two more years.

Sponsors & Collaborators

  • TRB Chemedica

    collaborator INDUSTRY
  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Marcia U Rezende, MD. PhD · Department of Orthopedics and Traumatology - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02335034 on ClinicalTrials.gov