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

August 19, 2019 updated by: Marcia Uchoa Rezende, University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational Program Associated (EPA)

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
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.
Other: Educational Program Isolated (EPI)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate function with the TUG (Time-up-Go test)
Time Frame: Baseline, 6, 12 and 24 months
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
Time Frame: Baseline, 6, 12 and 24 months
Apply the WOMAC questionnaire WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index)
Baseline, 6, 12 and 24 months
Evaluate improvement in function
Time Frame: Baseline, 6, 12 and 24 months
Apply the Lequesne questionnaire
Baseline, 6, 12 and 24 months
Evaluate percentage of body fat.
Time Frame: Baseline, 6, 12 and 24 months
Nine skinfolds measurements
Baseline, 6, 12 and 24 months
Level of physical activity
Time Frame: Baseline, 6, 12 and 24 months
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)
Time Frame: Baseline, 6, 12 and 24 months
Apply STS30 (Sit to Stand 30 SecondsTest)
Baseline, 6, 12 and 24 months
Evaluate the consumption of drugs
Time Frame: baseline to 6 months
Both groups, starting from inclusion will record the daily consumption of drugs (baseline to 6 months)
baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

November 15, 2018

Study Completion (Anticipated)

July 15, 2021

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14833/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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