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P.A.R.Q.V.E III - Comparison of the Educational Program With and Without Multidisciplinary Care (PARQVE3)

U

University of Sao Paulo General Hospital

Status

Unknown

Conditions

Metabolic Diseases
Osteoarthritis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02917655
14833/16

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Educational Program Associated (EPA)
Experimental group
Description:
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.
Treatment:
Behavioral: IPAQ
Behavioral: Numerical Rating Scales (NRS)
Behavioral: Sessions with the physical educators team
Behavioral: Two days of lectures
Behavioral: STS30
Behavioral: Lequesne
Behavioral: Session with the psychologists
Behavioral: Nutritional habits to be improved
Behavioral: TUG
Behavioral: Tampa Scale for Kinesiophobia (TSK)
Behavioral: Six-minute Test
Behavioral: Sessions with the physical therapy team
Behavioral: Womac
Educational Program Isolated (EPI)
Other group
Description:
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.
Treatment:
Behavioral: IPAQ
Behavioral: Numerical Rating Scales (NRS)
Behavioral: Two days of lectures
Behavioral: STS30
Behavioral: Lequesne
Behavioral: TUG
Behavioral: Tampa Scale for Kinesiophobia (TSK)
Behavioral: Six-minute Test
Behavioral: Womac

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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