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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2019

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.

Arms, Groups and Cohorts

  • Experimental: Study group
    • Intervention: study group will attend two days of classes (two months apart) with the seven professional teams, covering what is the disease arthritis, its causes and treatment options; what is disease, being ill, and the role of the patient in the treatment to obtain behavioral change; the importance of exercise in relieving symptoms, the importance of rest and proper ergonomics at home and at work; proper alimentation; the difference between labor work and regular physical activity as well as the importance of strength resistance and stretching exercises; and the importance of leisure. The second intervention verifies the acquired concepts.
  • Experimental: Control Group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Improvement in pain of patients with knee osteoarthritis by multi-professional care and education. (Visual Analogue Scale (VAS) and Womac)
    • Time Frame: 5 years
    • Visual Analogue Scale (VAS) and Womac pain at 6 months, 1, 2, 3 and 4 years
  • 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)
    • Time Frame: 5 years
    • Lequesne, Womac, TUG (Timed Up and Go), FTSST ( Five Time Sit to Stand Test), Sit to Stand 30 Second Test, Palmar pressure force, Digital pinch strength, Range of motion (ROM) of the upper limbs (UL), Application of HAQ (Health Assessment Questionnaire )and DASH (Disabilities of the Arm, Shoulder And Hand questionnaires) at 6 months, 1, 2, 3 and 4 years
  • Improvement in percentage of body fat of patients with knee osteoarthritis by multi-professional care and education. (skinfolds measurements)
    • Time Frame: 5 years
    • Nine skinfolds measurements at 6, 12, 24, 36 and 48 months
  • quality of life of patients with knee osteoarthritis by multi-professional care and education..
    • Time Frame: 5 years
    • SF-36 at 6, 12, 24, 36 and 48 months

Secondary Measures

  • 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)
    • Time Frame: 5 years
    • Minutes per week of light, moderate or intense physical acitivity
  • Evaluate changes in BMI of patients with knee osteoarthritis by multi-professional care and education.
    • Time Frame: 5 years
    • By measuring height and weight at 6, 12, 24, 36 and 48 months.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo General Hospital
  • Collaborator
    • TRB Chemedica
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marcia U Rezende, MD. PhD, Principal Investigator, Department of Orthopedics and Traumatology – Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

References

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WHO Scientific Group on the Burden of Musculoskeletal Conditions at the Start of the New Millennium. The burden of musculoskeletal conditions at the start of the new millennium. World Health Organ Tech Rep Ser. 2003;919:i-x, 1-218, back cover.

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Jørgensen KT, Pedersen BV, Nielsen NM, Hansen AV, Jacobsen S, Frisch M. Socio-demographic factors, reproductive history and risk of osteoarthritis in a cohort of 4.6 million Danish women and men. Osteoarthritis Cartilage. 2011 Oct;19(10):1176-82. doi: 10.1016/j.joca.2011.07.009. Epub 2011 Jul 27.

Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11. Review.

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