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

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

Interventions

BEHAVIORAL

Womac

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

BEHAVIORAL

Lequesne

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

BEHAVIORAL

Numerical Rating Scales (NRS)

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

BEHAVIORAL

IPAQ

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

BEHAVIORAL

STS30

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

BEHAVIORAL

TUG

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

BEHAVIORAL

Six-minute Test

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

BEHAVIORAL

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).

BEHAVIORAL

Session with the psychologists

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

BEHAVIORAL

Sessions with the physical therapy team

Participate in a extra session group with the physical therapists

BEHAVIORAL

Sessions with the physical educators team

Participate in a extra session group with the physical educators

BEHAVIORAL

Nutritional habits to be improved

Attend 3 extra meetings about nutrition.

BEHAVIORAL

Tampa Scale for Kinesiophobia (TSK)

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Marcia U Rezende, MD; PhD · Department of Orthopedics and Traumatology - Hospital das Clinicas da FMUSP

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

45 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-01

Primary Completion

2018-11-15

Completion

2021-07-15