OsteoarthritisPARQVE3NCT02917655
P.A.R.Q.V.E III - Comparison of the Educational Program With and Without Multidisciplinary Care
A study testing Womac, Lequesne and Numerical Rating Scales (NRS) in people with Osteoarthritis and Metabolic Diseases, run by University of Sao Paulo General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis, Metabolic Diseases
- What is being tested?
- Womac, Lequesne and Numerical Rating Scales (NRS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis, Metabolic Diseases
- Being tested
- Womac, Lequesne, Numerical Rating Scales (NRS), IPAQ, STS30
- Keywords
- Education, Quality of Life, Osteoarthritis, Metabolic Syndrome
- Medical subject headings
- Osteoarthritis, Metabolic Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WomacBehavioural
Answer WOMAC at baseline, 6, 12 and 24 months.
LequesneBehavioural
Answer Lequesne at baseline, 6, 12 and 24 months.
Numerical Rating Scales (NRS)Behavioural
Answer NRS at baseline, 6, 12 and 24 months.
IPAQBehavioural
Answer IPAQ at baseline, 6, 12 and 24 months.
STS30Behavioural
Perform the STS30 at baseline, 6, 12 and 24 months.
TUGBehavioural
Perform the TUG at baseline, 6, 12 and 24 months.
Six-minute TestBehavioural
Perform the six-minute test at baseline, 6, 12 and 24 months.
Two days of lecturesBehavioural
Participate in two days of classes about KOA, with the seven teams (orthopedics, psychology, physical therapy and fitness, occupational therapy, social workers and nutritionist).
Session with the psychologistsBehavioural
Participate in a extra session group with the psychology team about their experiences with the program
Sessions with the physical therapy teamBehavioural
Participate in a extra session group with the physical therapists
Sessions with the physical educators teamBehavioural
Participate in a extra session group with the physical educators
Nutritional habits to be improvedBehavioural
Attend 3 extra meetings about nutrition.
Tampa Scale for Kinesiophobia (TSK)Behavioural
Answer Tampa Scale for Kinesiophobia (TSK) at baseline, 6 months, 12 and 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Educational Program Associated (EPA) | Experimental | 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. Receives: 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) |
| Educational Program Isolated (EPI) | Other | 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. Receives: 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: Tampa Scale for Kinesiophobia (TSK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6, 12 and 24 months
Secondary outcomes (6)
Evaluate improvement in pain
Apply the WOMAC questionnaire WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index)
Measured: Baseline, 6, 12 and 24 months
Evaluate improvement in function
Apply the Lequesne questionnaire
Measured: Baseline, 6, 12 and 24 months
Evaluate percentage of body fat.
Nine skinfolds measurements
Measured: Baseline, 6, 12 and 24 months
Level of physical activity
Apply International Questionnaire physical activity Questionnaire-IPAQ short version.
Measured: Baseline, 6, 12 and 24 months
Evaluate function with the STS30 (Sit to Stand 30 SecondsTest)
Apply STS30 (Sit to Stand 30 SecondsTest)
Measured: Baseline, 6, 12 and 24 months
Evaluate the consumption of drugs
Both groups, starting from inclusion will record the daily consumption of drugs (baseline to 6 months)
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start1 Nov 2016
- Primary completion15 Nov 2018
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcia Uchoa Rezende, University of Sao Paulo General Hospital
- Investigators
- Marcia U Rezende, MD; PhD, Principal investigator, Department of Orthopedics and Traumatology - Hospital das Clinicas da FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917655
- Sponsor's protocol ID
- 14833/16
- Acronym
- PARQVE3
- Status last verified
- Aug 2019
- First submitted
- 7 Jul 2016
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lane NE, Brandt K, Hawker G, Peeva E, Schreyer E, Tsuji W, Hochberg MC. OARSI-FDA initiative: defining the disease state of osteoarthritis. Osteoarthritis Cartilage. 2011 May;19(5):478-82. doi: 10.1016/j.joca.2010.09.013. Epub 2011 Mar 23.
PubMed 21396464Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
PubMed 14710506WHO Scientific Group on the Burden of Musculoskeletal Conditions at the Start of the New Millennium. The burden of musculoskeletal conditions at the start of the new millennium. World Health Organ Tech Rep Ser. 2003;919:i-x, 1-218, back cover.
PubMed 14679827Kwok WY, Vliet Vlieland TP, Rosendaal FR, Huizinga TW, Kloppenburg M. Limitations in daily activities are the major determinant of reduced health-related quality of life in patients with hand osteoarthritis. Ann Rheum Dis. 2011 Feb;70(2):334-6. doi: 10.1136/ard.2010.133603. Epub 2010 Nov 15.
PubMed 21081529Dawson J, Linsell L, Zondervan K, Rose P, Randall T, Carr A, Fitzpatrick R. Epidemiology of hip and knee pain and its impact on overall health status in older adults. Rheumatology (Oxford). 2004 Apr;43(4):497-504. doi: 10.1093/rheumatology/keh086. Epub 2004 Feb 3.
PubMed 14762225Dixon T, Shaw M, Ebrahim S, Dieppe P. Trends in hip and knee joint replacement: socioeconomic inequalities and projections of need. Ann Rheum Dis. 2004 Jul;63(7):825-30. doi: 10.1136/ard.2003.012724.
PubMed 15194578Mahomed NN, Barrett J, Katz JN, Baron JA, Wright J, Losina E. Epidemiology of total knee replacement in the United States Medicare population. J Bone Joint Surg Am. 2005 Jun;87(6):1222-8. doi: 10.2106/JBJS.D.02546.
PubMed 15930530Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010 Jan;18(1):24-33. doi: 10.1016/j.joca.2009.08.010. Epub 2009 Sep 2.
PubMed 19751691Jorgensen KT, Pedersen BV, Nielsen NM, Hansen AV, Jacobsen S, Frisch M. Socio-demographic factors, reproductive history and risk of osteoarthritis in a cohort of 4.6 million Danish women and men. Osteoarthritis Cartilage. 2011 Oct;19(10):1176-82. doi: 10.1016/j.joca.2011.07.009. Epub 2011 Jul 27.
PubMed 21835256Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.
PubMed 18279766Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11.
PubMed 20170770Bruyere O, Cooper C, Pelletier JP, Branco J, Luisa Brandi M, Guillemin F, Hochberg MC, Kanis JA, Kvien TK, Martel-Pelletier J, Rizzoli R, Silverman S, Reginster JY. An algorithm recommendation for the management of knee osteoarthritis in Europe and internationally: a report from a task force of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Semin Arthritis Rheum. 2014 Dec;44(3):253-63. doi: 10.1016/j.semarthrit.2014.05.014. Epub 2014 May 14.
PubMed 24953861McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
PubMed 24462672Rosales Ade L, Brito NL, Frucchi R, de Campos GC, Pailo AF, de Rezende MU. Obesity, ostearthritis and clinical treatment. Acta Ortop Bras. 2014;22(3):136-9. doi: 10.1590/1413-78522014220300679.
PubMed 25061419Campos GC, Kohara MT, Rezende MU, Santana OF, Moreira MM, Camargo OP. Schooling of the patients and clinical application of questionnaires in osteoarthitis. Acta Ortop Bras. 2014;22(5):256-9. doi: 10.1590/1413-78522014220500980.
PubMed 25328433
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02917655
- Acronym / sponsor ID
- PARQVE3 / 14833/16
- Conditions
- Osteoarthritis, Metabolic Diseases
- Keywords
- Education, Quality of Life, Osteoarthritis, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Program Associated (EPA) | Experimental | 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)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. |
| Educational Program Isolated (EPI) | Other | 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: Tampa Scale for Kinesiophobia (TSK)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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WomacAnswer WOMAC at baseline, 6, 12 and 24 months. | Behavioural | Educational Program Associated (EPA), Educational Program Isolated (EPI) |
| LequesneAnswer Lequesne at baseline, 6, 12 and 24 months. | Behavioural | Educational Program Associated (EPA), Educational Program Isolated (EPI) |
| Numerical Rating Scales (NRS)Answer NRS at baseline, 6, 12 and 24 months. | Behavioural | Educational Program Associated (EPA), Educational Program Isolated (EPI) |
| IPAQAnswer IPAQ at baseline, 6, 12 and 24 months. | Behavioural | Educational Program Associated (EPA), Educational Program Isolated (EPI) |
| STS30Perform the STS30 at baseline, 6, 12 and 24 months. | Behavioural | Educational Program Associated (EPA), Educational Program Isolated (EPI) |
| TUGPerform the TUG at baseline, 6, 12 and 24 months. | Behavioural | Educational Program Associated (EPA), Educational Program Isolated (EPI) |
| Six-minute TestPerform the six-minute test at baseline, 6, 12 and 24 months. | Behavioural | Educational Program Associated (EPA), Educational Program Isolated (EPI) |
| Two days of lecturesParticipate in two days of classes about KOA, with the seven teams (orthopedics, psychology, physical therapy and fitness, occupational therapy, social workers and nutritionist). | Behavioural | Educational Program Associated (EPA), Educational Program Isolated (EPI) |
| Session with the psychologistsParticipate in a extra session group with the psychology team about their experiences with the program | Behavioural | Educational Program Associated (EPA) |
| Sessions with the physical therapy teamParticipate in a extra session group with the physical therapists | Behavioural | Educational Program Associated (EPA) |
| Sessions with the physical educators teamParticipate in a extra session group with the physical educators | Behavioural | Educational Program Associated (EPA) |
| Nutritional habits to be improvedAttend 3 extra meetings about nutrition. | Behavioural | Educational Program Associated (EPA) |
| Tampa Scale for Kinesiophobia (TSK)Answer Tampa Scale for Kinesiophobia (TSK) at baseline, 6 months, 12 and 24 months. | Behavioural | Educational Program Associated (EPA), Educational Program Isolated (EPI) |
Primary outcome
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.
6 secondary outcomes
Evaluate improvement in pain
Time frame: Baseline, 6, 12 and 24 months
Evaluate improvement in function
Time frame: Baseline, 6, 12 and 24 months
Evaluate percentage of body fat.
Time frame: Baseline, 6, 12 and 24 months
Level of physical activity
Time frame: Baseline, 6, 12 and 24 months
Evaluate function with the STS30 (Sit to Stand 30 SecondsTest)
Time frame: Baseline, 6, 12 and 24 months
Evaluate the consumption of drugs
Time frame: baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Background: PubMed 21396464Lane NE, Brandt K, Hawker G, Peeva E, Schreyer E, Tsuji W, Hochberg MC. OARSI-FDA initiative: defining the disease state of osteoarthritis. Osteoarthritis Cartilage. 2011 May;19(5):478-82. doi: 10.1016/j.joca.2010.09.013. Epub 2011 Mar 23.
- Background: PubMed 14710506Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
- Background: PubMed 14679827WHO Scientific Group on the Burden of Musculoskeletal Conditions at the Start of the New Millennium. The burden of musculoskeletal conditions at the start of the new millennium. World Health Organ Tech Rep Ser. 2003;919:i-x, 1-218, back cover.
- Background: PubMed 21081529Kwok WY, Vliet Vlieland TP, Rosendaal FR, Huizinga TW, Kloppenburg M. Limitations in daily activities are the major determinant of reduced health-related quality of life in patients with hand osteoarthritis. Ann Rheum Dis. 2011 Feb;70(2):334-6. doi: 10.1136/ard.2010.133603. Epub 2010 Nov 15.
- Background: PubMed 14762225Dawson J, Linsell L, Zondervan K, Rose P, Randall T, Carr A, Fitzpatrick R. Epidemiology of hip and knee pain and its impact on overall health status in older adults. Rheumatology (Oxford). 2004 Apr;43(4):497-504. doi: 10.1093/rheumatology/keh086. Epub 2004 Feb 3.
- Background: PubMed 15194578Dixon T, Shaw M, Ebrahim S, Dieppe P. Trends in hip and knee joint replacement: socioeconomic inequalities and projections of need. Ann Rheum Dis. 2004 Jul;63(7):825-30. doi: 10.1136/ard.2003.012724.
- Background: PubMed 15930530Mahomed NN, Barrett J, Katz JN, Baron JA, Wright J, Losina E. Epidemiology of total knee replacement in the United States Medicare population. J Bone Joint Surg Am. 2005 Jun;87(6):1222-8. doi: 10.2106/JBJS.D.02546.
- Background: PubMed 19751691Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010 Jan;18(1):24-33. doi: 10.1016/j.joca.2009.08.010. Epub 2009 Sep 2.
- Background: PubMed 21835256Jorgensen KT, Pedersen BV, Nielsen NM, Hansen AV, Jacobsen S, Frisch M. Socio-demographic factors, reproductive history and risk of osteoarthritis in a cohort of 4.6 million Danish women and men. Osteoarthritis Cartilage. 2011 Oct;19(10):1176-82. doi: 10.1016/j.joca.2011.07.009. Epub 2011 Jul 27.
- Background: PubMed 18279766Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.
- Background: PubMed 20170770Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11.
- Background: PubMed 24953861Bruyere O, Cooper C, Pelletier JP, Branco J, Luisa Brandi M, Guillemin F, Hochberg MC, Kanis JA, Kvien TK, Martel-Pelletier J, Rizzoli R, Silverman S, Reginster JY. An algorithm recommendation for the management of knee osteoarthritis in Europe and internationally: a report from a task force of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Semin Arthritis Rheum. 2014 Dec;44(3):253-63. doi: 10.1016/j.semarthrit.2014.05.014. Epub 2014 May 14.
- Dados preliminares do Censo 2010 já revelam mudanças na pirâmide etária brasileiraLink provided by the sponsor.
- POF 2008-2009: desnutrição cai e peso das crianças brasileiras ultrapassa padrão internacional.Link provided by the sponsor.
- PARQVE - Project Arthritis Recovering Quality of Life by means of Education. Short-term outcome in a randomized clinical trialLink provided by the sponsor.
- Prevalence and incidence of hand osteoarthritis and upper limb complaints in patients with knee osteoarthritis .... in a educational osteoarthritis programLink provided by the sponsor.
- 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)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia U Rezende, MD; PhD principal investigator
Department of Orthopedics and Traumatology - Hospital das Clinicas da FMUSP
Questions about this trial
What is this clinical trial studying?
A study testing Womac, Lequesne and Numerical Rating Scales (NRS) in people with Osteoarthritis and Metabolic Diseases, run by University of Sao Paulo General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate function with the TUG (Time-up-Go test) (time frame: Baseline, 6, 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02917655, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.