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

Osteoarthritis Clinical Trial

— PARQVE3  

Official title:

PARQVE - Project Arthritis Recovering Quality of Life by Means of Education - A Prospective Randomized Study Comparing the Educational Program With and Without Multidisciplinary Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02917655
• Other study ID #: 14833/16
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: July 15, 2021

Study information

• Verified date: August 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Given the inclusion criteria, patients undergo pre-evaluation by the multidisciplinary group composed of teams of orthopedic doctors, nutritionists, physical therapists, physical educators:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: July 15, 2021
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Metabolic Diseases
• Osteoarthritis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

References & Publications (21)

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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. — View Citation

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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. — View Citation

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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. Review. — View Citation

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. Review. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate improvement in pain	Apply the WOMAC questionnaire WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index)	Baseline, 6, 12 and 24 months
Secondary	Evaluate improvement in function	Apply the Lequesne questionnaire	Baseline, 6, 12 and 24 months
Secondary	Evaluate percentage of body fat.	Nine skinfolds measurements	Baseline, 6, 12 and 24 months
Secondary	Level of physical activity	Apply International Questionnaire physical activity Questionnaire-IPAQ short version.	Baseline, 6, 12 and 24 months
Secondary	Evaluate function with the STS30 (Sit to Stand 30 SecondsTest)	Apply STS30 (Sit to Stand 30 SecondsTest)	Baseline, 6, 12 and 24 months
Secondary	Evaluate the consumption of drugs	Both groups, starting from inclusion will record the daily consumption of drugs (baseline to 6 months)	baseline to 6 months

External Links

•   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)
•   Dados preliminares do Censo 2010 já revelam mudanças na pirâmide etária brasileira
•   PARQVE - Project Arthritis Recovering Quality of Life by means of Education. Short-term outcome in a randomized clinical trial
•   POF 2008-2009: desnutrição cai e peso das crianças brasileiras ultrapassa padrão internacional.
•   Prevalence and incidence of hand osteoarthritis and upper limb complaints in patients with knee osteoarthritis .... in a educational osteoarthritis program