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

Primary Purpose

Osteoarthritis, Metabolic Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Womac
Lequesne
Numerical Rating Scales (NRS)
IPAQ
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)
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Education, Quality of Life, Osteoarthritis, Metabolic Syndrome

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Educational Program Associated (EPA)

    Educational Program Isolated (EPI)

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Evaluate improvement in pain
    Apply the WOMAC questionnaire WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index)
    Evaluate improvement in function
    Apply the Lequesne questionnaire
    Evaluate percentage of body fat.
    Nine skinfolds measurements
    Level of physical activity
    Apply International Questionnaire physical activity Questionnaire-IPAQ short version.
    Evaluate function with the STS30 (Sit to Stand 30 SecondsTest)
    Apply STS30 (Sit to Stand 30 SecondsTest)
    Evaluate the consumption of drugs
    Both groups, starting from inclusion will record the daily consumption of drugs (baseline to 6 months)

    Full Information

    First Posted
    July 7, 2016
    Last Updated
    August 19, 2019
    Sponsor
    University of Sao Paulo General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02917655
    Brief Title
    P.A.R.Q.V.E III - Comparison of the Educational Program With and Without Multidisciplinary Care
    Acronym
    PARQVE3
    Official Title
    PARQVE - Project Arthritis Recovering Quality of Life by Means of Education - A Prospective Randomized Study Comparing the Educational Program With and Without Multidisciplinary Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2016 (Actual)
    Primary Completion Date
    November 15, 2018 (Actual)
    Study Completion Date
    July 15, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Metabolic Diseases
    Keywords
    Education, Quality of Life, Osteoarthritis, Metabolic Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Educational Program Associated (EPA)
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Educational Program Isolated (EPI)
    Arm Type
    Other
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Womac
    Intervention Description
    Answer WOMAC at baseline, 6, 12 and 24 months.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lequesne
    Intervention Description
    Answer Lequesne at baseline, 6, 12 and 24 months.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Numerical Rating Scales (NRS)
    Intervention Description
    Answer NRS at baseline, 6, 12 and 24 months.
    Intervention Type
    Behavioral
    Intervention Name(s)
    IPAQ
    Intervention Description
    Answer IPAQ at baseline, 6, 12 and 24 months.
    Intervention Type
    Behavioral
    Intervention Name(s)
    STS30
    Intervention Description
    Perform the STS30 at baseline, 6, 12 and 24 months.
    Intervention Type
    Behavioral
    Intervention Name(s)
    TUG
    Intervention Description
    Perform the TUG at baseline, 6, 12 and 24 months.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Six-minute Test
    Intervention Description
    Perform the six-minute test at baseline, 6, 12 and 24 months.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Two days of lectures
    Intervention Description
    Participate in two days of classes about KOA, with the seven teams (orthopedics, psychology, physical therapy and fitness, occupational therapy, social workers and nutritionist).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Session with the psychologists
    Intervention Description
    Participate in a extra session group with the psychology team about their experiences with the program
    Intervention Type
    Behavioral
    Intervention Name(s)
    Sessions with the physical therapy team
    Intervention Description
    Participate in a extra session group with the physical therapists
    Intervention Type
    Behavioral
    Intervention Name(s)
    Sessions with the physical educators team
    Intervention Description
    Participate in a extra session group with the physical educators
    Intervention Type
    Behavioral
    Intervention Name(s)
    Nutritional habits to be improved
    Intervention Description
    Attend 3 extra meetings about nutrition.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Tampa Scale for Kinesiophobia (TSK)
    Intervention Description
    Answer Tampa Scale for Kinesiophobia (TSK) at baseline, 6 months, 12 and 24 months.
    Primary Outcome Measure Information:
    Title
    Evaluate function with the TUG (Time-up-Go test)
    Description
    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.
    Time Frame
    Baseline, 6, 12 and 24 months
    Secondary Outcome Measure Information:
    Title
    Evaluate improvement in pain
    Description
    Apply the WOMAC questionnaire WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index)
    Time Frame
    Baseline, 6, 12 and 24 months
    Title
    Evaluate improvement in function
    Description
    Apply the Lequesne questionnaire
    Time Frame
    Baseline, 6, 12 and 24 months
    Title
    Evaluate percentage of body fat.
    Description
    Nine skinfolds measurements
    Time Frame
    Baseline, 6, 12 and 24 months
    Title
    Level of physical activity
    Description
    Apply International Questionnaire physical activity Questionnaire-IPAQ short version.
    Time Frame
    Baseline, 6, 12 and 24 months
    Title
    Evaluate function with the STS30 (Sit to Stand 30 SecondsTest)
    Description
    Apply STS30 (Sit to Stand 30 SecondsTest)
    Time Frame
    Baseline, 6, 12 and 24 months
    Title
    Evaluate the consumption of drugs
    Description
    Both groups, starting from inclusion will record the daily consumption of drugs (baseline to 6 months)
    Time Frame
    baseline to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marcia U Rezende, MD; PhD
    Organizational Affiliation
    Department of Orthopedics and Traumatology - Hospital das Clinicas da FMUSP
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Description
    POF 2008-2009: desnutrição cai e peso das crianças brasileiras ultrapassa padrão internacional.
    URL
    https://www.omicsonline.org/peer-reviewed/parqveproject-arthritis-recovering-quality-of-life-by-means-of-education-shortterm-outcome-in-a-randomized-clinical-trial-20432.html
    Description
    PARQVE - Project Arthritis Recovering Quality of Life by means of Education. Short-term outcome in a randomized clinical trial
    URL
    http://www.scirp.org/journal/PaperInformation.aspx?paperID=62765
    Description
    Prevalence and incidence of hand osteoarthritis and upper limb complaints in patients with knee osteoarthritis .... in a educational osteoarthritis program
    URL
    http://www.scirp.org/journal/PaperInformation.aspx?PaperID=63851
    Description
    Analysis of anthropometric measurements and dietary intake in patients undergoing a multi-professional ostearthritis education program (PARQVE - Project Arthritis Recovering Quality of Life by means of Education)

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

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