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Project Arthritis Recovering Quality of Life Through Education 70+ (PARQVE)

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ClinicalTrials.gov Identifier: NCT04058002
Recruitment Status : Not yet recruiting
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Marcia Uchoa Rezende, University of Sao Paulo General Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Multiprofessional treatment and Educational Program Associated (EPA+C+BCAA) with supplementation of creatine and BCAA. Other: Multiprofessional treatment and Educational Program Associated (EPA+C) with supplementation of creatine only. Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Project Arthritis Recovering Quality of Life Through Education 70+
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
Multiprofessional treatment and Educational Program Associated (EPA+C+BCAA) with supplementation of creatine and BCAA.
Other: 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)

Active Comparator: Control group
Multiprofessional treatment and Educational Program Associated (EPA+C) with supplementation of creatine only.
Other: 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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Change of results in the sit to stand 30 seconds test [ Time Frame: 12 months ]
    Perform sit to stand 30 seconds test, recording the number of stands a person can complete in 30 seconds, more fast better.

  2. Change of results in the Time up and go test [ Time Frame: 6 months and 12 months ]
    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.

  3. Change of results in the Womac questionnaire [ Time Frame: 6 months and 12 months ]
    Answer Womac Questionnaire - Ranges: minimum 0 (Better, no pain and limitation) / maximum 96 (Worst pain and limitation)

  4. Change of results in the Lequesne questionnaire [ Time Frame: 6 months and 12 months ]
    Answer Lequesne Questionnaire - Ranges: minimum 0 (Better, no limitation) / maximum 24 (Worst limitation)

  5. Change of results in the Visual Analogue Scale [ Time Frame: 6 months and 12 months ]
    Answer Visual Analogue Scale - Ranges: minimum 0 (Better, no pain) / maximum 100 (Worst pain)

  6. Change of results in the EuroQol Scale [ Time Frame: 6 months and 12 months ]
    Answer EuroQol Scale - Ranges: minimum 0 (Better) / maximum 2 (Worst)

  7. Change fat percentage [ Time Frame: 6 months and 12 months ]
    Calculate fat percentage

  8. Change lean mass percentage [ Time Frame: 6 months and 12 months ]
    Calculate lean mass



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).
  • 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

Exclusion Criteria:

  • 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.

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): NCT04058002


Contacts
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Contact: Livia Abreu 1126612473 murmedicina@outlook.com

Locations
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Brazil
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Guilherme P Ocampos, MD University of São Paulo General Hospital

Publications:

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Responsible Party: Marcia Uchoa Rezende, Full Professor in Orthopedics and Traumatology, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04058002     History of Changes
Other Study ID Numbers: CAAE: 04019418.7.0000.0068
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marcia Uchoa Rezende, University of Sao Paulo General Hospital:
Osteoarthritis
Knee
Quality of Life
Sarcopenia
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases