NCT02917655: PARQVE3

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

Status unknown NA Last updated 21 August 2019

What this trial tests

NA trial testing Womac in Osteoarthritis in 90 participants. Status unknown.

Timeline

1 November 2016

Primary endpoint
15 November 2018

15 July 2021

Quick facts

Lead sponsor	University of Sao Paulo General Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	1 November 2016
Primary completion	15 November 2018
Estimated completion	15 July 2021

Drugs / interventions tested

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

Conditions studied

• Osteoarthritis — all drugs for Osteoarthritis →
• Metabolic Diseases — all drugs for Metabolic Diseases →

Sponsor

University of Sao Paulo General Hospital

Who can join

Adults 45 to 75, any sex, with Osteoarthritis or Metabolic Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.