Knee OsteoarthritisPARQVENCT04058002
Project Arthritis Recovering Quality of Life Through Education 70+
A study testing Multiprofessional treatment and Educational Program Associated (EPA+C+BCAA) with supplementation of creatine and BCAA. and Multiprofessional treatment and Educational Program Associated (EPA+C) with supplementation of creatine only. in people with Knee Osteoarthritis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Introduction: Quadriceps weakness was previously associated with functional impairment of osteoarthritis (OA). Evidence also suggests that muscle strength may prevent the progression of existing OA. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Multiprofessional treatment and Educational Program Associated (EPA+C+BCAA) with supplementation of creatine and BCAA. and Multiprofessional treatment and Educational Program Associated (EPA+C) with supplementation of creatine only.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Aug 2019to 15 Oct 2020
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men and women diagnosed with OAJ with or without metabolic syndrome (ie at least two of: overweight / obese, hyperglycemia, dyslipidemia, hypertension)
- Age greater than or equal to 70 years.
- Classified as degrees I to III of Kelgreen and Lawrence (K-L), that is, any degree of gonarthritis without obliteration of joint space.
- Indication of clinical treatment of OA
- Patients without disabsorbing syndrome or inflammatory diseases of the gastrointestinal tract (GIT).
- Patients not undergoing gastroplasty or surgery that altered the transit of food in the TGI (Roux "Y", for example).
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- Patients with creatinine clearance greater than 60 ml / min / 1.73m2
- Patients not submitted to previous arthroplasty in the lower limbs.
- Patients not submitted to infiltration in the knees up to 6 months before the study.
- Patients with no personal history of cognitive, psychiatric and / or neurological disorders, whose symptoms presented at the time of evaluation are related or significantly interfere with the functions of attention, memory, logical reasoning, comprehension, in order to impair the assimilation of the given guidelines.
- Ability to read, understand and respond to the questionnaires
Who cannot join
- Missing the schedules and not performing the tasks as performed by the professionals.
- Patients who develop allergy or intolerance to creatine, dextrose or BCAA during the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-010
About this study
Introduction: Quadriceps weakness was previously associated with functional impairment of osteoarthritis (OA). Evidence also suggests that muscle strength may prevent the progression of existing OA. It is estimated that the decline in muscle mass between 40 and 80 years is between 30% and 50%, with reported losses in functional capacity reaching 3% each year beyond the age of 60 years. Therefore, procedures capable of increasing the effects of exercise on muscle strength and function may be beneficial for elderly patients with knee OA. The results of our studies have shown that with each year of life the patient loses strength gain capacity. Objective: To evaluate if a multiprofessional educational program associated with BCAA and creatine supplementation improves the quality of life, function, pain and body composition of patients with OA and age greater than or equal to 70 years. METHODS: 34 patients with knee OA and age greater than or equal to 70 years will undergo an educational and physical training program lasting 20 weeks. Half of the patients will receive creatine (control) and the others will receive creatine and BCAA (study). Patients will be evaluated through functional tests (sit-up and 30-second tests and time up and go), standardized questionnaires (WOMAC and Lequesne), quality of life scales (Euroqol-EQ-5D-5L), pain (through VAS), body composition and bone density (through densitometry), and level of physical activity. All of the above parameters will be assessed at the beginning of the study and 6 and 12 months later. All project costs will be reported and a cost-effectiveness and cost-utility analysis will be performed. All project costs will be reported and a cost-effectiveness and cost-utility analysis will be performed.
Read the detailed description
Osteoarthritis (OA) is the most common form of arthritis, affecting mainly women. Patients with OA present pain that usually worsens with weight support and improves with rest, as well as morning stiffness and after periods of inactivity.
Quadriceps weakness was previously associated with functional impairment of OA. Evidence also suggests that muscle strength may prevent the progression of existing OA. In fact, positive associations were found between increased quadriceps strength and self-efficacy of ambulation, reduction of pain and improvement of function, emphasizing the role of muscle strengthening in the treatment of knee OA.
It is estimated that the decline in muscle mass between 40 and 80 years is between 30% and 50%, with reported losses in functional capacity reaching 3% each year after the age of 60 years. Therefore, procedures capable of enhancing the effects of exercise on muscle strength and function may be beneficial for elderly patients with knee OA.
The results of our previous studies have shown that with each year of life the patient loses strength gain capacity.
Creatine is a natural amine endogenously synthesized by the liver, kidney and pancreas or obtained in the diet from red meat, seafood and dairy products. Creatine plays an important role in rapid energy supply, being stored mainly in the skeletal muscles (90%) as phosphocreatine, a high energy phosphate involved in the rapid resynthesis of adenosine triphosphate during muscle contraction. It has already been demonstrated that the combination of resistance training and creatine supplementation is superior to exercise alone in the elderly and has proved to be a useful tool in the elderly with knee OA.
Studies have demonstrated the need for a higher protein intake in the elderly with some studies showing greater protein synthesis and improved body composition parameters.
The investigators believe that an education and physical activity program, used in the previous work of the authors that presented improvement of WOMAC, that can be reproduced in any basic health care unit, along with supplementation with creatine and branched chain amino acids can lead to an improvement functional evaluation of elderly patients with knee OA.
- Conditions
- Knee Osteoarthritis
- Being tested
- Multiprofessional treatment and Educational Program Associated (EPA+C+BCAA) with supplementation of creatine and BCAA., Multiprofessional treatment and Educational Program Associated (EPA+C) with supplementation of creatine only.
- Keywords
- Osteoarthritis, Knee, Quality of Life, Sarcopenia
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiprofessional treatment and Educational Program Associated (EPA+C+BCAA) with supplementation of creatine and BCAA.Other
17 patients will participate in two days of lectures two-months apart on the subject of knee OA, but will also come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits to be improved; at months 4 and 6 to participate in 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). Patients will be supplemented with creatine 5 grams and maltodextrin 100g, 30 minutes before training. At breakfast they will also ingest 5 grams of BCAA (1,200 milligrams of leucine, 600 milligrams of isoleucine and 600 milligrams of valine per dose)
Multiprofessional treatment and Educational Program Associated (EPA+C) with supplementation of creatine only.Other
17 patients will participate in two days of lectures two-months apart on the subject of knee OA, but will also come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits to be improved; at months 4 and 6 to participate in 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). Patients will be supplemented with creatine 5 grams and maltodextrin 100g, 30 minutes before training. At breakfast they will also ingest 5 grams of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Multiprofessional treatment and Educational Program Associated (EPA+C+BCAA) with supplementation of creatine and BCAA. Receives: Other: Multiprofessional treatment and Educational Program Associated (EPA+C+BCAA) with supplementation of creatine and BCAA. |
| Control group | Active comparator | Multiprofessional treatment and Educational Program Associated (EPA+C) with supplementation of creatine only. Receives: Other: Multiprofessional treatment and Educational Program Associated (EPA+C) with supplementation of creatine only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants who improve function by performing the sit to stand 30 seconds test (STS30)
Compare supplementation with creatine and BCAA to supplementation with creatine only improves the functional results of patients in the sit to stand 30 seconds (STS30)
Measured: 6 months
Secondary outcomes (8)
Change of results in the sit to stand 30 seconds test
Perform sit to stand 30 seconds test, recording the number of stands a person can complete in 30 seconds, more fast better.
Measured: 12 months
Change of results in the Time up and go test
Perform time up and go test, The time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down, faster perform better.
Measured: 6 months and 12 months
Change of results in the Womac questionnaire
Answer Womac Questionnaire - Ranges: minimum 0 (Better, no pain and limitation) / maximum 96 (Worst pain and limitation)
Measured: 6 months and 12 months
Change of results in the Lequesne questionnaire
Answer Lequesne Questionnaire - Ranges: minimum 0 (Better, no limitation) / maximum 24 (Worst limitation)
Measured: 6 months and 12 months
Change of results in the Visual Analogue Scale
Answer Visual Analogue Scale - Ranges: minimum 0 (Better, no pain) / maximum 100 (Worst pain)
Measured: 6 months and 12 months
Change of results in the EuroQol Scale
Answer EuroQol Scale - Ranges: minimum 0 (Better) / maximum 2 (Worst)
Measured: 6 months and 12 months
Change fat percentage
Calculate fat percentage
Measured: 6 months and 12 months
Change lean mass percentage
Calculate lean mass
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start15 Aug 2019 (estimated)
- Primary completion15 Feb 2020 (estimated)
- Study completion15 Oct 2020 (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 Knee 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 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
- Guilherme P Ocampos, MD, Principal investigator, University of São Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058002
- Sponsor's protocol ID
- CAAE: 04019418.7.0000.0068
- Acronym
- PARQVE
- Status last verified
- Aug 2019
- First submitted
- 26 Jun 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
PubMed 18163497Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15. doi: 10.1002/1529-0131(200009)43:93.0.CO;2-P. No abstract available.
PubMed 11014340Slemenda C, Brandt KD, Heilman DK, Mazzuca S, Braunstein EM, Katz BP, Wolinsky FD. Quadriceps weakness and osteoarthritis of the knee. Ann Intern Med. 1997 Jul 15;127(2):97-104. doi: 10.7326/0003-4819-127-2-199707150-00001.
PubMed 9230035Lange AK, Vanwanseele B, Fiatarone Singh MA. Strength training for treatment of osteoarthritis of the knee: a systematic review. Arthritis Rheum. 2008 Oct 15;59(10):1488-94. doi: 10.1002/art.24118.
PubMed 18821647Altman RD. Early management of osteoarthritis. Am J Manag Care. 2010 Mar;16 Suppl Management:S41-7.
PubMed 20297876Patel HP, Syddall HE, Jameson K, Robinson S, Denison H, Roberts HC, Edwards M, Dennison E, Cooper C, Aihie Sayer A. Prevalence of sarcopenia in community-dwelling older people in the UK using the European Working Group on Sarcopenia in Older People (EWGSOP) definition: findings from the Hertfordshire Cohort Study (HCS). Age Ageing. 2013 May;42(3):378-84. doi: 10.1093/ageing/afs197. Epub 2013 Feb 5.
PubMed 23384705Reaes FM, Ivo MMAA, Scarcella DDS, Almeida LC, Suzuki RM, Rezende MU. EFFECT OF THE P.A.R.Q.V.E ON RHIZARTHRITIS. Acta Ortop Bras. 2018 Jan-Feb;26(1):41-47. doi: 10.1590/1413-785220182601184420.
PubMed 29977144Wyss M, Kaddurah-Daouk R. Creatine and creatinine metabolism. Physiol Rev. 2000 Jul;80(3):1107-213. doi: 10.1152/physrev.2000.80.3.1107.
PubMed 10893433Gualano B, Macedo AR, Alves CR, Roschel H, Benatti FB, Takayama L, de Sa Pinto AL, Lima FR, Pereira RM. Creatine supplementation and resistance training in vulnerable older women: a randomized double-blind placebo-controlled clinical trial. Exp Gerontol. 2014 May;53:7-15. doi: 10.1016/j.exger.2014.02.003. Epub 2014 Feb 13.
PubMed 24530883Brose A, Parise G, Tarnopolsky MA. Creatine supplementation enhances isometric strength and body composition improvements following strength exercise training in older adults. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):11-9. doi: 10.1093/gerona/58.1.b11.
PubMed 12560406Devries MC, Phillips SM. Creatine supplementation during resistance training in older adults-a meta-analysis. Med Sci Sports Exerc. 2014 Jun;46(6):1194-203. doi: 10.1249/MSS.0000000000000220.
PubMed 24576864Gualano B, Rawson ES, Candow DG, Chilibeck PD. Creatine supplementation in the aging population: effects on skeletal muscle, bone and brain. Amino Acids. 2016 Aug;48(8):1793-805. doi: 10.1007/s00726-016-2239-7. Epub 2016 Apr 23.
PubMed 27108136Pinto CL, Botelho PB, Carneiro JA, Mota JF. Impact of creatine supplementation in combination with resistance training on lean mass in the elderly. J Cachexia Sarcopenia Muscle. 2016 Sep;7(4):413-21. doi: 10.1002/jcsm.12094. Epub 2016 Jan 18.
PubMed 27239423Chilibeck PD, Kaviani M, Candow DG, Zello GA. Effect of creatine supplementation during resistance training on lean tissue mass and muscular strength in older adults: a meta-analysis. Open Access J Sports Med. 2017 Nov 2;8:213-226. doi: 10.2147/OAJSM.S123529. eCollection 2017.
PubMed 29138605Neves M Jr, Gualano B, Roschel H, Fuller R, Benatti FB, Pinto AL, Lima FR, Pereira RM, Lancha AH Jr, Bonfa E. Beneficial effect of creatine supplementation in knee osteoarthritis. Med Sci Sports Exerc. 2011 Aug;43(8):1538-43. doi: 10.1249/MSS.0b013e3182118592.
PubMed 21311365
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Arthritis Recovering Quality of Life Through Education 70+
- ClinicalTrials.gov ID
- NCT04058002
- Acronym / sponsor ID
- PARQVE / CAAE: 04019418.7.0000.0068
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Knee, Quality of Life, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 15 Aug 2019 (estimated)
- Primary completion
- 15 Feb 2020 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 15 Aug 2019 (actual)
- 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.
Introduction: Quadriceps weakness was previously associated with functional impairment of osteoarthritis (OA). Evidence also suggests that muscle strength may prevent the progression of existing OA. It is estimated that the decline in muscle mass between 40 and 80 years is between 30% and 50%, with reported losses in functional capacity reaching 3% each year beyond the age of 60 years. Therefore, procedures capable of increasing the effects of exercise on muscle strength and function may be beneficial for elderly patients with knee OA. The results of our studies have shown that with each year of life the patient loses strength gain capacity. Objective: To evaluate if a multiprofessional educational program associated with BCAA and creatine supplementation improves the quality of life, function, pain and body composition of patients with OA and age greater than or equal to 70 years. METHODS: 34 patients with knee OA and age greater than or equal to 70 years will undergo an educational and physical training program lasting 20 weeks. Half of the patients will receive creatine (control) and the others will receive creatine and BCAA (study). Patients will be evaluated through functional tests (sit-up and 30-second tests and time up and go), standardized questionnaires (WOMAC and Lequesne), quality of life scales (Euroqol-EQ-5D-5L), pain (through VAS), body composition and bone density (through densitometry), and level of physical activity. All of the above parameters will be assessed at the beginning of the study and 6 and 12 months later. All project costs will be reported and a cost-effectiveness and cost-utility analysis will be performed. All project costs will be reported and a cost-effectiveness and cost-utility analysis will be performed.
Detailed description
Osteoarthritis (OA) is the most common form of arthritis, affecting mainly women. Patients with OA present pain that usually worsens with weight support and improves with rest, as well as morning stiffness and after periods of inactivity.
Quadriceps weakness was previously associated with functional impairment of OA. Evidence also suggests that muscle strength may prevent the progression of existing OA. In fact, positive associations were found between increased quadriceps strength and self-efficacy of ambulation, reduction of pain and improvement of function, emphasizing the role of muscle strengthening in the treatment of knee OA.
It is estimated that the decline in muscle mass between 40 and 80 years is between 30% and 50%, with reported losses in functional capacity reaching 3% each year after the age of 60 years. Therefore, procedures capable of enhancing the effects of exercise on muscle strength and function may be beneficial for elderly patients with knee OA.
The results of our previous studies have shown that with each year of life the patient loses strength gain capacity.
Creatine is a natural amine endogenously synthesized by the liver, kidney and pancreas or obtained in the diet from red meat, seafood and dairy products. Creatine plays an important role in rapid energy supply, being stored mainly in the skeletal muscles (90%) as phosphocreatine, a high energy phosphate involved in the rapid resynthesis of adenosine triphosphate during muscle contraction. It has already been demonstrated that the combination of resistance training and creatine supplementation is superior to exercise alone in the elderly and has proved to be a useful tool in the elderly with knee OA.
Studies have demonstrated the need for a higher protein intake in the elderly with some studies showing greater protein synthesis and improved body composition parameters.
The investigators believe that an education and physical activity program, used in the previous work of the authors that presented improvement of WOMAC, that can be reproduced in any basic health care unit, along with supplementation with creatine and branched chain amino acids can lead to an improvement functional evaluation of elderly patients with knee OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Multiprofessional treatment and Educational Program Associated (EPA+C+BCAA) with supplementation of creatine and BCAA.Multiprofessional treatment and Educational Program Associated (EPA+C+BCAA) with supplementation of creatine and BCAA. |
| Control group | Active comparator | Other: Multiprofessional treatment and Educational Program Associated (EPA+C) with supplementation of creatine only.Multiprofessional treatment and Educational Program Associated (EPA+C) with supplementation of creatine only. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Men and women diagnosed with OAJ with or without metabolic syndrome (ie at least two of: overweight / obese, hyperglycemia, dyslipidemia, hypertension)
- Age greater than or equal to 70 years.
- Classified as degrees I to III of Kelgreen and Lawrence (K-L), that is, any degree of gonarthritis without obliteration of joint space.
- Indication of clinical treatment of OA
- Patients without disabsorbing syndrome or inflammatory diseases of the gastrointestinal tract (GIT).
Key exclusion criteria (2 listed)
- Missing the schedules and not performing the tasks as performed by the professionals.
- Patients who develop allergy or intolerance to creatine, dextrose or BCAA during the study.
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 |
|---|---|---|
| Multiprofessional treatment and Educational Program Associated (EPA+C+BCAA) with supplementation of creatine and BCAA.17 patients will participate in two days of lectures two-months apart on the subject of knee OA, but will also come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits to be improved; at months 4 and 6 to participate in 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). Patients will be supplemented with creatine 5 grams and maltodextrin 100g, 30 minutes before training. At breakfast they will also ingest 5 grams of BCAA (1,200 milligrams of leucine, 600 milligrams of isoleucine and 600 milligrams of valine per dose) | Other | Experimental |
| Multiprofessional treatment and Educational Program Associated (EPA+C) with supplementation of creatine only.17 patients will participate in two days of lectures two-months apart on the subject of knee OA, but will also come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits to be improved; at months 4 and 6 to participate in 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). Patients will be supplemented with creatine 5 grams and maltodextrin 100g, 30 minutes before training. At breakfast they will also ingest 5 grams of placebo. | Other | Control group |
Primary outcome
Participants who improve function by performing the sit to stand 30 seconds test (STS30)
Time frame: 6 months
Compare supplementation with creatine and BCAA to supplementation with creatine only improves the functional results of patients in the sit to stand 30 seconds (STS30)
8 secondary outcomes
Change of results in the sit to stand 30 seconds test
Time frame: 12 months
Change of results in the Time up and go test
Time frame: 6 months and 12 months
Change of results in the Womac questionnaire
Time frame: 6 months and 12 months
Change of results in the Lequesne questionnaire
Time frame: 6 months and 12 months
Change of results in the Visual Analogue Scale
Time frame: 6 months and 12 months
Change of results in the EuroQol Scale
Time frame: 6 months and 12 months
Change fat percentage
Time frame: 6 months and 12 months
Change lean mass percentage
Time frame: 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Background: PubMed 18163497Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
- Background: PubMed 11014340Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15. doi: 10.1002/1529-0131(200009)43:93.0.CO;2-P. No abstract available.
- Background: PubMed 9230035Slemenda C, Brandt KD, Heilman DK, Mazzuca S, Braunstein EM, Katz BP, Wolinsky FD. Quadriceps weakness and osteoarthritis of the knee. Ann Intern Med. 1997 Jul 15;127(2):97-104. doi: 10.7326/0003-4819-127-2-199707150-00001.
- Background: PubMed 18821647Lange AK, Vanwanseele B, Fiatarone Singh MA. Strength training for treatment of osteoarthritis of the knee: a systematic review. Arthritis Rheum. 2008 Oct 15;59(10):1488-94. doi: 10.1002/art.24118.
- Background: PubMed 20297876Altman RD. Early management of osteoarthritis. Am J Manag Care. 2010 Mar;16 Suppl Management:S41-7.
- Background: PubMed 23384705Patel HP, Syddall HE, Jameson K, Robinson S, Denison H, Roberts HC, Edwards M, Dennison E, Cooper C, Aihie Sayer A. Prevalence of sarcopenia in community-dwelling older people in the UK using the European Working Group on Sarcopenia in Older People (EWGSOP) definition: findings from the Hertfordshire Cohort Study (HCS). Age Ageing. 2013 May;42(3):378-84. doi: 10.1093/ageing/afs197. Epub 2013 Feb 5.
- Background: PubMed 29977144Reaes FM, Ivo MMAA, Scarcella DDS, Almeida LC, Suzuki RM, Rezende MU. EFFECT OF THE P.A.R.Q.V.E ON RHIZARTHRITIS. Acta Ortop Bras. 2018 Jan-Feb;26(1):41-47. doi: 10.1590/1413-785220182601184420.
- Background: PubMed 10893433Wyss M, Kaddurah-Daouk R. Creatine and creatinine metabolism. Physiol Rev. 2000 Jul;80(3):1107-213. doi: 10.1152/physrev.2000.80.3.1107.
- Background: PubMed 24530883Gualano B, Macedo AR, Alves CR, Roschel H, Benatti FB, Takayama L, de Sa Pinto AL, Lima FR, Pereira RM. Creatine supplementation and resistance training in vulnerable older women: a randomized double-blind placebo-controlled clinical trial. Exp Gerontol. 2014 May;53:7-15. doi: 10.1016/j.exger.2014.02.003. Epub 2014 Feb 13.
- Background: PubMed 12560406Brose A, Parise G, Tarnopolsky MA. Creatine supplementation enhances isometric strength and body composition improvements following strength exercise training in older adults. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):11-9. doi: 10.1093/gerona/58.1.b11.
- Background: PubMed 24576864Devries MC, Phillips SM. Creatine supplementation during resistance training in older adults-a meta-analysis. Med Sci Sports Exerc. 2014 Jun;46(6):1194-203. doi: 10.1249/MSS.0000000000000220.
- Background: PubMed 27108136Gualano B, Rawson ES, Candow DG, Chilibeck PD. Creatine supplementation in the aging population: effects on skeletal muscle, bone and brain. Amino Acids. 2016 Aug;48(8):1793-805. doi: 10.1007/s00726-016-2239-7. Epub 2016 Apr 23.
- 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.
Guilherme P Ocampos, MD principal investigator
University of São Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiprofessional treatment and Educational Program Associated (EPA+C+BCAA) with supplementation of creatine and BCAA. and Multiprofessional treatment and Educational Program Associated (EPA+C) with supplementation of creatine only. in people with Knee Osteoarthritis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 11 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 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Livia Abreu (1126612473, murmedicina@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants who improve function by performing the sit to stand 30 seconds test (STS30) (time frame: 6 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 NCT04058002, 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 15 Aug 2019.