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临床试验/NCT02335034
NCT02335034已完成不适用

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.

University of Sao Paulo General Hospital4 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
222
试验地点
4
主要终点
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)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

盲法说明

single-blind

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

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)

时间窗: 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)

时间窗: 5 years

Nine skinfolds measurements at 6, 12, 24, 36 and 48 months

Improvement in pain of patients with knee osteoarthritis by multi-professional care and education. (Visual Analogue Scale (VAS) and Womac)

时间窗: 5 years

Visual Analogue Scale (VAS) and Womac pain at 6 months, 1, 2, 3 and 4 years

quality of life of patients with knee osteoarthritis by multi-professional care and education..

时间窗: 5 years

SF-36 at 6, 12, 24, 36 and 48 months

次要结局

  • 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)(5 years)
  • Evaluate changes in BMI of patients with knee osteoarthritis by multi-professional care and education.(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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