P.A.R.Q.V.E III - Comparison of the Educational Program With and Without Multidisciplinary Care

NCT02917655 | Unknown

• 1 other identifier: 14833/16
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

BACKGROUND: Osteoarthritis (OA), and particularly knee osteoarthritis (KOA) is a disorder that greatly impairs the quality of life of patients and its incidence increases with longevity, obesity and lower socioeconomic and educational level. It is expected that 40% of people over 60 have symptomatic OA of the knees and hips. The core treatment of OA is education, weight loss and increased physical activity. We create an educational program that improved function of the patients given by the sit-to-stand 30 seconds test (STS30). However, weight loss, an important foundation of clinical treatment, was only effective (more than 2 points in BMI) in 10% of the program participants. For greater effectiveness in weight loss and adherence to physical activity, we prepared an intensive program with more intensive nutritional care, psychological, physical therapy and physical trainers and compare the existing program educators. OBJECTIVE: To compare an educational program isolated to an educational program associated with nutritional consultations, group therapy sessions and progressed physiotherapy sessions to sessions with physical educators in patients with KOA and comorbidities (metabolic syndrome). 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.

Conditions

Osteoarthritis; Metabolic Diseases

Keywords

Education; Quality of Life; Osteoarthritis; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Evaluate function with the TUG (Time-up-Go test)

  Apply TUG (Time-up-Go test) The data will be evaluated with absolute measures and changes in respect to baseline values at 6, 12 and 24 months.

  Baseline, 6, 12 and 24 months

Secondary Outcomes (6)

• Evaluate improvement in pain

  Baseline, 6, 12 and 24 months

• Evaluate improvement in function

  Baseline, 6, 12 and 24 months

• Evaluate percentage of body fat.

  Baseline, 6, 12 and 24 months

• Level of physical activity

  Baseline, 6, 12 and 24 months

• Evaluate function with the STS30 (Sit to Stand 30 SecondsTest)

  Baseline, 6, 12 and 24 months

Study Arms (2)

Educational Program Associated (EPA)

EXPERIMENTAL

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.

Behavioral: Womac; Behavioral: Lequesne; Behavioral: Numerical Rating Scales (NRS); Behavioral: IPAQ; Behavioral: STS30; Behavioral: TUG; Behavioral: Six-minute Test; Behavioral: Two days of lectures; Behavioral: Session with the psychologists; Behavioral: Sessions with the physical therapy team; Behavioral: Sessions with the physical educators team; Behavioral: Nutritional habits to be improved; Behavioral: Tampa Scale for Kinesiophobia (TSK)

Educational Program Isolated (EPI)

OTHER

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.

Behavioral: Womac; Behavioral: Lequesne; Behavioral: Numerical Rating Scales (NRS); Behavioral: IPAQ; Behavioral: STS30; Behavioral: TUG; Behavioral: Six-minute Test; Behavioral: Two days of lectures; Behavioral: Tampa Scale for Kinesiophobia (TSK)

Interventions

Womac BEHAVIORAL

Answer WOMAC at baseline, 6, 12 and 24 months.

Educational Program Associated (EPA); Educational Program Isolated (EPI)

Lequesne BEHAVIORAL

Answer Lequesne at baseline, 6, 12 and 24 months.

Educational Program Associated (EPA); Educational Program Isolated (EPI)

Numerical Rating Scales (NRS) BEHAVIORAL

Answer NRS at baseline, 6, 12 and 24 months.

Educational Program Associated (EPA); Educational Program Isolated (EPI)

IPAQ BEHAVIORAL

Answer IPAQ at baseline, 6, 12 and 24 months.

Educational Program Associated (EPA); Educational Program Isolated (EPI)

STS30 BEHAVIORAL

Perform the STS30 at baseline, 6, 12 and 24 months.

Educational Program Associated (EPA); Educational Program Isolated (EPI)

TUG BEHAVIORAL

Perform the TUG at baseline, 6, 12 and 24 months.

Educational Program Associated (EPA); Educational Program Isolated (EPI)

Six-minute Test BEHAVIORAL

Perform the six-minute test at baseline, 6, 12 and 24 months.

Educational Program Associated (EPA); Educational Program Isolated (EPI)

Two days of lectures BEHAVIORAL

Participate in two days of classes about KOA, with the seven teams (orthopedics, psychology, physical therapy and fitness, occupational therapy, social workers and nutritionist).

Educational Program Associated (EPA); Educational Program Isolated (EPI)

Session with the psychologists BEHAVIORAL

Participate in a extra session group with the psychology team about their experiences with the program

Educational Program Associated (EPA)

Sessions with the physical therapy team BEHAVIORAL

Participate in a extra session group with the physical therapists

Educational Program Associated (EPA)

Sessions with the physical educators team BEHAVIORAL

Participate in a extra session group with the physical educators

Educational Program Associated (EPA)

Nutritional habits to be improved BEHAVIORAL

Attend 3 extra meetings about nutrition.

Educational Program Associated (EPA)

Tampa Scale for Kinesiophobia (TSK) BEHAVIORAL

Answer Tampa Scale for Kinesiophobia (TSK) at baseline, 6 months, 12 and 24 months.

Educational Program Associated (EPA); Educational Program Isolated (EPI)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women diagnosed with KOA with comorbidities (metabolic syndrome, ie, Osteoarthritis Knee + at least two of: overweight / obesity, hyperglycemia, dyslipidemia, hyperurecemia, hypertension, polyarthrosis) and up to 75 years old, capable of reading, understand and responding to the WOMAC questionnaire.
• 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.

You may not qualify if:

• Patients who have cognitive, and psychiatric or neurological disorders, whose symptoms during the evaluation are related to or significantly interfere in the functions of attention, memory, logical reasoning, understanding, interaction with the group, that would prevent assimilation of the given guidelines.
• Missing interventions

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Related Publications (21)

• 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.

  PMID: 21396464 BACKGROUND

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

  PMID: 14710506 BACKGROUND

• 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.

  PMID: 14679827 BACKGROUND

• 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.

  PMID: 21081529 BACKGROUND

• 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.

  PMID: 14762225 BACKGROUND

• 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.

  PMID: 15194578 BACKGROUND

• 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.

  PMID: 15930530 BACKGROUND

• 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.

  PMID: 19751691 BACKGROUND

• 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.

  PMID: 21835256 BACKGROUND

• Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, 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 II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.

  PMID: 18279766 BACKGROUND

• 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.

  PMID: 20170770 BACKGROUND

• 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.

  PMID: 24953861 BACKGROUND

• 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.

  PMID: 24462672 BACKGROUND

• Rosales Ade L, Brito NL, Frucchi R, de Campos GC, Pailo AF, de Rezende MU. Obesity, ostearthritis and clinical treatment. Acta Ortop Bras. 2014;22(3):136-9. doi: 10.1590/1413-78522014220300679.

  PMID: 25061419 BACKGROUND

• Campos GC, Kohara MT, Rezende MU, Santana OF, Moreira MM, Camargo OP. Schooling of the patients and clinical application of questionnaires in osteoarthitis. Acta Ortop Bras. 2014;22(5):256-9. doi: 10.1590/1413-78522014220500980.

  PMID: 25328433 BACKGROUND

• Shin D. Association between metabolic syndrome, radiographic knee osteoarthritis, and intensity of knee pain: results of a national survey. J Clin Endocrinol Metab. 2014 Sep;99(9):3177-83. doi: 10.1210/jc.2014-1043. Epub 2014 Apr 29.

  PMID: 24780047 BACKGROUND

• 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.

  PMID: 3068365 BACKGROUND

• 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.

  PMID: 23918463 BACKGROUND

• Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.

  PMID: 10960937 BACKGROUND

• Britto RR, Probst VS, de Andrade AF, Samora GA, Hernandes NA, Marinho PE, Karsten M, Pitta F, Parreira VF. Reference equations for the six-minute walk distance based on a Brazilian multicenter study. Braz J Phys Ther. 2013 Nov-Dec;17(6):556-63. doi: 10.1590/S1413-35552012005000122. Epub 2013 Nov 14.

  PMID: 24271092 BACKGROUND

• Sanghi D, Srivastava RN, Singh A, Kumari R, Mishra R, Mishra A. The association of anthropometric measures and osteoarthritis knee in non-obese subjects: a cross sectional study. Clinics (Sao Paulo). 2011;66(2):275-9. doi: 10.1590/s1807-59322011000200016.

  PMID: 21484046 BACKGROUND

Related Links

• 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)

MeSH Terms

Conditions

Osteoarthritis; Metabolic Diseases; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders

Study Officials

• Marcia U Rezende, MD; PhD

  Department of Orthopedics and Traumatology - Hospital das Clinicas da FMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; PhD

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: September 28, 2016
• Study Start: November 1, 2016
• Primary Completion: November 15, 2018
• Study Completion: July 15, 2021
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share