Clinical Trials Directory

Trials / Completed

CompletedNCT02335034

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

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
222 (actual)
Sponsor
University of Sao Paulo General Hospital · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
BEHAVIORALStudy Group Educational courses, DVD, print material of lectures2 Educational courses (two months apart). Receive DVD and printed material of the lectures.
BEHAVIORALControl Group only make evaluations / consultations with all professional teamsEvaluations 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.

Timeline

Start date
2014-12-01
Primary completion
2019-03-01
Completion
2019-03-01
First posted
2015-01-09
Last updated
2020-06-09

Locations

2 sites across 1 country: Brazil

Source: ClinicalTrials.gov record NCT02335034. Inclusion in this directory is not an endorsement.