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

NCT ID: NCT02335034

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

single-blind

Study Groups

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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.

Group Type EXPERIMENTAL

Study Group Educational courses, DVD, print material of lectures

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Control Group only make evaluations / consultations with all professional teams

Intervention Type BEHAVIORAL

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.

Interventions

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Study Group Educational courses, DVD, print material of lectures

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TRB Chemedica

INDUSTRY

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcia U Rezende, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedics and Traumatology - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

Locations

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Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, , Brazil

Site Status

Instituto de Ortopedia e Traumatologia - HCFMUSP

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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Lane NE, Brandt K, Hawker G, Peeva E, Schreyer E, Tsuji W, Hochberg MC. OARSI-FDA initiative: defining the disease state of osteoarthritis. Osteoarthritis Cartilage. 2011 May;19(5):478-82. doi: 10.1016/j.joca.2010.09.013. Epub 2011 Mar 23.

Reference Type BACKGROUND
PMID: 21396464 (View on PubMed)

Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.

Reference Type BACKGROUND
PMID: 14710506 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14679827 (View on PubMed)

Kwok WY, Vliet Vlieland TP, Rosendaal FR, Huizinga TW, Kloppenburg M. Limitations in daily activities are the major determinant of reduced health-related quality of life in patients with hand osteoarthritis. Ann Rheum Dis. 2011 Feb;70(2):334-6. doi: 10.1136/ard.2010.133603. Epub 2010 Nov 15.

Reference Type BACKGROUND
PMID: 21081529 (View on PubMed)

Dawson J, Linsell L, Zondervan K, Rose P, Randall T, Carr A, Fitzpatrick R. Epidemiology of hip and knee pain and its impact on overall health status in older adults. Rheumatology (Oxford). 2004 Apr;43(4):497-504. doi: 10.1093/rheumatology/keh086. Epub 2004 Feb 3.

Reference Type BACKGROUND
PMID: 14762225 (View on PubMed)

Dixon T, Shaw M, Ebrahim S, Dieppe P. Trends in hip and knee joint replacement: socioeconomic inequalities and projections of need. Ann Rheum Dis. 2004 Jul;63(7):825-30. doi: 10.1136/ard.2003.012724.

Reference Type BACKGROUND
PMID: 15194578 (View on PubMed)

Mahomed NN, Barrett J, Katz JN, Baron JA, Wright J, Losina E. Epidemiology of total knee replacement in the United States Medicare population. J Bone Joint Surg Am. 2005 Jun;87(6):1222-8. doi: 10.2106/JBJS.D.02546.

Reference Type BACKGROUND
PMID: 15930530 (View on PubMed)

Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010 Jan;18(1):24-33. doi: 10.1016/j.joca.2009.08.010. Epub 2009 Sep 2.

Reference Type BACKGROUND
PMID: 19751691 (View on PubMed)

Jorgensen 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.

Reference Type BACKGROUND
PMID: 21835256 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20170770 (View on PubMed)

Rodrigues da Silva JM, de Rezende MU, Spada TC, da Silva Francisco L, Sabine de Farias FE, Clemente da Silva CA, Cernigoy CHA, Greve JMD, Ciolac EG. Educational program promoting regular physical exercise improves functional capacity and daily living physical activity in subjects with knee osteoarthritis. BMC Musculoskelet Disord. 2017 Dec 27;18(1):546. doi: 10.1186/s12891-017-1912-7.

Reference Type DERIVED
PMID: 29282054 (View on PubMed)

Related Links

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Other Identifiers

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12671/14

Identifier Type: -

Identifier Source: org_study_id

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