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

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Other: Multiprofessional treatment and Educational Program Associated (EPA+C) with supplementation of creatine only.; Other: Multiprofessional treatment and Educational Program Associated (EPA+C+BCAA) with supplementation of creatine and BCAA.

Study type: Interventional

Funder types: Other

Identifiers

NCT04058002

CAAE: 04019418.7.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Experimental

Experimental group

Description:

Multiprofessional treatment and Educational Program Associated (EPA+C+BCAA) with supplementation of creatine and BCAA.

Treatment:

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

Control group

Active Comparator group

Description:

Multiprofessional treatment and Educational Program Associated (EPA+C) with supplementation of creatine only.

Treatment:

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