P.A.R.Q.V.E III - Comparison of the Educational Program With and Without Multidisciplinary Care
NCT ID: NCT02917655
Last Updated: 2019-08-21
Study Results
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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UNKNOWN
NA
90 participants
INTERVENTIONAL
2016-11-01
2021-07-15
Brief Summary
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METHODS: Ninety patients with OAJ and co-morbidities (Two or more of: overweight or obesity, hyperglycemia, dyslipidemia, hyperuricemia, high blood pressure) will be divided into two groups: study (S) and control (C). Both groups will attend the two-day multi-professional classes on OA with two months interval. But the study group will also make three group consultations about nutrition, 1 extra session of group therapy with psychology team and 7 exercise sessions in groups with physical therapy and subsequently 7 sessions with physical educators. The groups will be evaluated for weight, height (to calculate BMI), waist-hip ratio, percentage of body fat, consumption of daily medications, WOMAC, Lequesne, IPAQ, Tampa Scale for Kinesiophobia (TSK), Sit to stand 30 seconds test (STS30), timed-up- and-go (TUG) and six minute test. At inclusion, six, twelve and 24 months after the classes.
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Detailed Description
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Orthopedics - it is treating the patients according to the guidelines of OARSI, offering everything we have for the treatment of OA at the Hospital das Clinicas.
Nutrition - It will measure the skinfold of all patients at baseline and at six and twelve months. As the draw, will attend the study group at 1, 3 and 5 months after the first class and the control group lose weight significantly less than the study group will meet the control group after one year in the same manner than has undergone the study group .
Physiotherapy - Undertake the test and sit ups, Timed-Up-and-Go (TUG) test and Sit to stand 30 seconds test (STS30) including six, twelve and 24 months after inclusion. The physiotherapy group will care study group sessions in a group of patients once a week for 4 weeks, 2 times a week for 1 month and 1x / month in the third month, giving exercises to be performed daily and charging them through the registration of patients. If the results of six and twelve months show better in the study group, the control group will do the same interventions the study group one year later.
Physical Education - will apply the questionnaire International Physical Activity Questionnaire, IPAQ, Tampa Scale for Kinesiophobia (TSK) and will make up test and down stairs and evaluating short version flexibility, inclusion, six, 12 and 24 months. After three months of exercise guided by physiotherapists, the study group will begin an exercise program with physical education teachers to become able to carry out alone or join a gym at the end of the sixth month of the program. It will also provide weekly classes for 1 month, biweekly in the second month and last month in the third charging the daily activities in the record of the patient's notebook.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Educational Program Associated (EPA)
45 patients will participate in two days of lectures two-months apart on the subject of knee OA, but will also come to the hospital on months 1, 3 and 5 after the first class to consult about nutritional habits to be improved; on month 4 for a group therapy session with the psychologists, 7 sessions with the physical therapy team followed by 7 sessions with the physical educators team (once a week/4 weeks and once every two weeks, three times).
Answer WOMAC, Lequesne, Numerical Rating Scales (NRS), IPAQ, Tampa Scale for Kinesiophobia (TSK); perform the STS30, TUG, six-minute test have calculated BMI and body fat percentage at baseline evaluations, 6, 12 and 24 months.
Womac
Answer WOMAC at baseline, 6, 12 and 24 months.
Lequesne
Answer Lequesne at baseline, 6, 12 and 24 months.
Numerical Rating Scales (NRS)
Answer NRS at baseline, 6, 12 and 24 months.
IPAQ
Answer IPAQ at baseline, 6, 12 and 24 months.
STS30
Perform the STS30 at baseline, 6, 12 and 24 months.
TUG
Perform the TUG at baseline, 6, 12 and 24 months.
Six-minute Test
Perform the six-minute test at baseline, 6, 12 and 24 months.
Two days of lectures
Participate in two days of classes about KOA, with the seven teams (orthopedics, psychology, physical therapy and fitness, occupational therapy, social workers and nutritionist).
Session with the psychologists
Participate in a extra session group with the psychology team about their experiences with the program
Sessions with the physical therapy team
Participate in a extra session group with the physical therapists
Sessions with the physical educators team
Participate in a extra session group with the physical educators
Nutritional habits to be improved
Attend 3 extra meetings about nutrition.
Tampa Scale for Kinesiophobia (TSK)
Answer Tampa Scale for Kinesiophobia (TSK) at baseline, 6 months, 12 and 24 months.
Educational Program Isolated (EPI)
45 patients will participate in two days of lectures two-months apart on the subject of knee OA.
Answer WOMAC, Lequesne, Numerical Rating Scales (NRS), IPAQ, Tampa Scale for Kinesiophobia (TSK); perform the STS30, TUG, six-minute test have calculated BMI and body fat percentage at baseline evaluations, 6, 12 and 24 months.
Womac
Answer WOMAC at baseline, 6, 12 and 24 months.
Lequesne
Answer Lequesne at baseline, 6, 12 and 24 months.
Numerical Rating Scales (NRS)
Answer NRS at baseline, 6, 12 and 24 months.
IPAQ
Answer IPAQ at baseline, 6, 12 and 24 months.
STS30
Perform the STS30 at baseline, 6, 12 and 24 months.
TUG
Perform the TUG at baseline, 6, 12 and 24 months.
Six-minute Test
Perform the six-minute test at baseline, 6, 12 and 24 months.
Two days of lectures
Participate in two days of classes about KOA, with the seven teams (orthopedics, psychology, physical therapy and fitness, occupational therapy, social workers and nutritionist).
Tampa Scale for Kinesiophobia (TSK)
Answer Tampa Scale for Kinesiophobia (TSK) at baseline, 6 months, 12 and 24 months.
Interventions
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Womac
Answer WOMAC at baseline, 6, 12 and 24 months.
Lequesne
Answer Lequesne at baseline, 6, 12 and 24 months.
Numerical Rating Scales (NRS)
Answer NRS at baseline, 6, 12 and 24 months.
IPAQ
Answer IPAQ at baseline, 6, 12 and 24 months.
STS30
Perform the STS30 at baseline, 6, 12 and 24 months.
TUG
Perform the TUG at baseline, 6, 12 and 24 months.
Six-minute Test
Perform the six-minute test at baseline, 6, 12 and 24 months.
Two days of lectures
Participate in two days of classes about KOA, with the seven teams (orthopedics, psychology, physical therapy and fitness, occupational therapy, social workers and nutritionist).
Session with the psychologists
Participate in a extra session group with the psychology team about their experiences with the program
Sessions with the physical therapy team
Participate in a extra session group with the physical therapists
Sessions with the physical educators team
Participate in a extra session group with the physical educators
Nutritional habits to be improved
Attend 3 extra meetings about nutrition.
Tampa Scale for Kinesiophobia (TSK)
Answer Tampa Scale for Kinesiophobia (TSK) at baseline, 6 months, 12 and 24 months.
Eligibility Criteria
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Inclusion Criteria
* Classified as stages I to III Kelgreen and Lawrence (K-L), i.e. without any degree of gonarthritis obliteration of joint space narrowing.
* With clinical treatment indication of OA.
Exclusion Criteria
* Missing interventions
45 Years
75 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Marcia Uchoa Rezende
MD; PhD
Principal Investigators
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Marcia U Rezende, MD; PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Orthopedics and Traumatology - Hospital das Clinicas da FMUSP
References
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Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
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.
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.
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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.
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.
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.
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Bruyere O, Cooper C, Pelletier JP, Branco J, Luisa Brandi M, Guillemin F, Hochberg MC, Kanis JA, Kvien TK, Martel-Pelletier J, Rizzoli R, Silverman S, Reginster JY. An algorithm recommendation for the management of knee osteoarthritis in Europe and internationally: a report from a task force of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Semin Arthritis Rheum. 2014 Dec;44(3):253-63. doi: 10.1016/j.semarthrit.2014.05.014. Epub 2014 May 14.
McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
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Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
Konstantinidis GA, Aletras VH, Kanakari KA, Natsis K, Bellamy N, Niakas D. Comparative validation of the WOMAC osteoarthritis and Lequesne algofunctional indices in Greek patients with hip or knee osteoarthritis. Qual Life Res. 2014 Mar;23(2):539-48. doi: 10.1007/s11136-013-0490-x. Epub 2013 Aug 6.
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Related Links
Access external resources that provide additional context or updates about the study.
POF 2008-2009: desnutrição cai e peso das crianças brasileiras ultrapassa padrão internacional.
PARQVE - Project Arthritis Recovering Quality of Life by means of Education. Short-term outcome in a randomized clinical trial
Prevalence and incidence of hand osteoarthritis and upper limb complaints in patients with knee osteoarthritis .... in a educational osteoarthritis program
Analysis of anthropometric measurements and dietary intake in patients undergoing a multi-professional ostearthritis education program (PARQVE - Project Arthritis Recovering Quality of Life by means of Education)
Other Identifiers
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14833/16
Identifier Type: -
Identifier Source: org_study_id
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