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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02335034
Enrollment
222
Registered
2015-01-09
Start date
2014-12-31
Completion date
2019-03-31
Last updated
2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis, Osteoarthritis

Keywords

Osteoarthritis, Knee, Education, Quality of life, Treatment outcome, Musculoskeletal pain

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.

Interventions

BEHAVIORALStudy Group Educational courses, DVD, print material of lectures

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

BEHAVIORALControl 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

TRB Chemedica
CollaboratorINDUSTRY
University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Masking description

single-blind

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in pain of patients with knee osteoarthritis by multi-professional care and education. (Visual Analogue Scale (VAS) and Womac)5 yearsVisual 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)5 yearsLequesne, 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)5 yearsNine skinfolds measurements at 6, 12, 24, 36 and 48 months
quality of life of patients with knee osteoarthritis by multi-professional care and education..5 yearsSF-36 at 6, 12, 24, 36 and 48 months

Secondary

MeasureTime frameDescription
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 yearsMinutes per week of light, moderate or intense physical acitivity
Evaluate changes in BMI of patients with knee osteoarthritis by multi-professional care and education.5 yearsBy measuring height and weight at 6, 12, 24, 36 and 48 months.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026