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

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ClinicalTrials.gov Identifier: NCT02917655
Recruitment Status : Active, not recruiting
First Posted : September 28, 2016
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Marcia Uchoa Rezende, University of Sao Paulo General Hospital

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Metabolic Diseases Behavioral: Womac Behavioral: Lequesne Behavioral: Numerical Rating Scales (NRS) Behavioral: IPAQ Behavioral: STS30 Behavioral: TUG Behavioral: Six-minute Test Behavioral: Two days of lectures Behavioral: Session with the psychologists Behavioral: Sessions with the physical therapy team Behavioral: Sessions with the physical educators team Behavioral: Nutritional habits to be improved Behavioral: Tampa Scale for Kinesiophobia (TSK) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : November 15, 2018
Estimated Study Completion Date : July 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. Evaluate improvement in function [ Time Frame: Baseline, 6, 12 and 24 months ]
    Apply the Lequesne questionnaire

  3. Evaluate percentage of body fat. [ Time Frame: Baseline, 6, 12 and 24 months ]
    Nine skinfolds measurements

  4. Level of physical activity [ Time Frame: Baseline, 6, 12 and 24 months ]
    Apply International Questionnaire physical activity Questionnaire-IPAQ short version.

  5. 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)

  6. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917655


Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Marcia U Rezende, MD; PhD Department of Orthopedics and Traumatology - Hospital das Clinicas da FMUSP
Additional Information:
Publications:

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Responsible Party: Marcia Uchoa Rezende, MD; PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02917655    
Other Study ID Numbers: 14833/16
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marcia Uchoa Rezende, University of Sao Paulo General Hospital:
Education
Quality of Life
Osteoarthritis
Metabolic Syndrome
Additional relevant MeSH terms:
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Osteoarthritis
Metabolic Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases