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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Osteoarthritis, Metabolic Diseases

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational Program Associated (EPA)<br>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<br>* Answer WOMAC at baseline, 6, 12 and 24 months.<br>Behavioral: Lequesne<br>* Answer Lequesne at baseline, 6, 12 and 24 months.<br>Behavioral: Numerical Rating Scales (NRS)<br>* Answer NRS at baseline, 6, 12 and 24 months.<br>Behavioral: IPAQ<br>* Answer IPAQ at baseline, 6, 12 and 24 months.<br>Behavioral: STS30<br>* Perform the STS30 at baseline, 6, 12 and 24 months.<br>Behavioral: TUG<br>* Perform the TUG at baseline, 6, 12 and 24 months.<br>Behavioral: Six-minute Test<br>* Perform the six-minute test at baseline, 6, 12 and 24 months.<br>Behavioral: Two days of lectures<br>* Participate in two days of classes about KOA, with the seven teams (orthopedics, psychology, physical therapy and fitness, occupational therapy, social workers and nutritionist).<br>Behavioral: Session with the psychologists<br>* Participate in a extra session group with the psychology team about their experiences with the program<br>Behavioral: Sessions with the physical therapy team<br>* Participate in a extra session group with the physical therapists<br>Behavioral: Sessions with the physical educators team<br>* Participate in a extra session group with the physical educators<br>Behavioral: Nutritional habits to be improved<br>* Attend 3 extra meetings about nutrition.<br>Behavioral: Tampa Scale for Kinesiophobia (TSK)<br>* Answer Tampa Scale for Kinesiophobia (TSK) at baseline, 6 months, 12 and 24 months.<br>|
| Other: Educational Program Isolated (EPI)<br>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<br>* Answer WOMAC at baseline, 6, 12 and 24 months.<br>Behavioral: Lequesne<br>* Answer Lequesne at baseline, 6, 12 and 24 months.<br>Behavioral: Numerical Rating Scales (NRS)<br>* Answer NRS at baseline, 6, 12 and 24 months.<br>Behavioral: IPAQ<br>* Answer IPAQ at baseline, 6, 12 and 24 months.<br>Behavioral: STS30<br>* Perform the STS30 at baseline, 6, 12 and 24 months.<br>Behavioral: TUG<br>* Perform the TUG at baseline, 6, 12 and 24 months.<br>Behavioral: Six-minute Test<br>* Perform the six-minute test at baseline, 6, 12 and 24 months.<br>Behavioral: Two days of lectures<br>* Participate in two days of classes about KOA, with the seven teams (orthopedics, psychology, physical therapy and fitness, occupational therapy, social workers and nutritionist).<br>Behavioral: Tampa Scale for Kinesiophobia (TSK)<br>* Answer Tampa Scale for Kinesiophobia (TSK) at baseline, 6 months, 12 and 24 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate improvement in pain | Apply the WOMAC questionnaire WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) | Baseline, 6, 12 and 24 months | 
| Evaluate improvement in function | Apply the Lequesne questionnaire | Baseline, 6, 12 and 24 months | 
| Evaluate percentage of body fat. | Nine skinfolds measurements | Baseline, 6, 12 and 24 months | 
| Level of physical activity | Apply International Questionnaire physical activity Questionnaire-IPAQ short version. | Baseline, 6, 12 and 24 months | 
| Evaluate function with the STS30 (Sit to Stand 30 SecondsTest) | Apply STS30 (Sit to Stand 30 SecondsTest) | Baseline, 6, 12 and 24 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Education, Quality of Life, Osteoarthritis, Metabolic Syndrome