Clinical trial NCT02335034: Project Arthritis Recovering Quality of Life by Means Education II (PARQVE II)
Official title: Project Osteoarthritis: Recovering Quality of Life by Means Education II (PARQVE II) - A Prospective Randomized Study Comparing the Multidisciplinary Care Associated With Education to Multidisciplinary Treatment Without Education.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Osteoarthritis
Keywords: Osteoarthritis
Knee
Education
Quality of life
Treatment outcome
Musculoskeletal pain
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: TRB Chemedica
First posted: 2015-01-09
Enrollment: 222
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Men and women diagnosed with primary osteoarthritis of the knee,
* Classified as stages I to III of Kelgreen and Lawrence (KL), ie any degree of gonarthritis without obliteration of the joint space.
* With indication for clinical treatment of OA.

Exclusion Criteria:

* Patients with cognitive, psychiatric and neurological disorders or whose symptoms during the evaluation are related or significantly interfere in the functions of attention, memory, logical thinking, understanding and interaction with the group in order to hinder the assimilation of the given guidelines.

Missing classroom interventions

Primary outcomes:
measure: Improvement in pain of patients with knee osteoarthritis by multi-professional care and education. (Visual Analogue Scale (VAS) and Womac)
timeFrame: 5 years
measure: Improvement in function of patients with knee osteoarthritis by multi-professional care and education. (testing and HAQ (Health Assessment Questionnaire )and DASH (Disabilities of the Arm, Shoulder And Hand questionnaires)
timeFrame: 5 years
measure: Improvement in percentage of body fat of patients with knee osteoarthritis by multi-professional care and education. (skinfolds measurements)
timeFrame: 5 years
measure: quality of life of patients with knee osteoarthritis by multi-professional care and education..
timeFrame: 5 years
Secondary outcomes:
measure: Evaluate increase physical activity of patients with knee osteoarthritis by multi-professional care and education. (Minutes per week of light, moderate or intense physical acitivity)
timeFrame: 5 years
measure: Evaluate changes in BMI of patients with knee osteoarthritis by multi-professional care and education.
timeFrame: 5 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
city: São Paulo
country: Brazil
facility: Instituto de Ortopedia e Traumatologia - HCFMUSP
Study officials:
affiliation: Department of Orthopedics and Traumatology - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
name: Marcia U Rezende, MD. PhD
role: PRINCIPAL_INVESTIGATOR
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