Study Results
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Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2018-03-01
2023-12-31
Brief Summary
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The main treatment for loss of muscle strength in these patients is rehabilitation which includes strength and endurance exercises.However, in some cases, amino acids such as Glutamine (Gln) have been employed as an aid to recover muscle strength, but the evidence on this topic is not consistent and is inconclusive. Therefore, the main purpose of this study is to investigate if the oral complementation with Glutamine in combination with strength and resistance training can improve the muscle strength of the quadriceps femoral in patients with anterior cruciate ligament reconstruction compared with those receiving a placebo after six weeks of intervention.
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Detailed Description
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Patients: Fifty men 20 to 50 years old, between 15 to 19 weeks after surgical reconstruction of anterior cruciate ligament and moderate loss of muscle strength of knee (assessment with computerized dynamometer), will be recruited from the Sport Rehabilitation department, and the treatment will be carried out in the Sport Medicine area, both of the National Institute of Rehabilitation in Mexico City. Patients with diabetes, obesity, hypertension, kidney or liver diseases or with glucocorticoid treatment, and athletes will not be included.
Intervention: The sample will be randomized in two groups. At the beginning and at the end of the training session, the experimental group will receive 10 grams of glutamine, and the control group will receive 10 grams of placebo (maltodextrin), both dissolved in 120 milliliters of water and all participants will not be aware of the supplement content.
Both groups will participate in the same standardized resistance training program, to ensure progression (or regression if necessary) to all training components and adherence to the intervention, each participant will do the training program in a therapeutic gym of Sport Medicine area three times per week, during 6 weeks of follow-up. One training session consists of 20 minutes of warm-up, 40 to 60 minutes of aerobic and anaerobic exercises and 15 minutes of cooling down. The exercises of the lower part of the body consist in 3 sets of 10 repetitions for healthy knees, and 12 repetitions for knees with anterior cruciate ligament reconstruction in a modular leg press, leg curl and leg extension machine.
All participants, irrespective of the supplement that they receive, will be closely monitored by a physician specialist in Sport Medicine and a nutritionist, who will give a dietary program to standardize protein consumption. Status nutritional will be assessed according to Body Mass Index \[(BMI) 19.9-24.9, 25-29.9\].
Muscle strength will be measured by a computer dynamometer. The reliability of the dynamometry will be evaluated by Intraclass Correlation Coefficient (ICC). Thigh circumference will be measured by a anthropometric technique (Nutritionists certified by the International Society for the Advance of Kinanthropometry in level one, will carry out the measurement). Fasting glucose, lipid profile and liver function test will be carried out in the clinical laboratory of National Institute of Rehabilitation. The measurements are going to be held twice; before the first training session, and 6 weeks after.
For each participant the study duration will start in the first training session until 6 weeks after. Endpoints assessments will be performed at baseline (2 days before starting the training program) and after 6 weeks of follow-up (2 days after the last training session). Data will be collected by study investigators blinded to the allocation of the participants.
Comparison: The control group will receive maltodextrin powder (placebo) dissolved in 120 milliliters of water. The placebo will be inside gray envelopes, in the same manner that the glutamine was administered.
Outcomes: The main outcome is to change the strength of quadriceps femoris (assessment by isokinetic dynamometer).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Glutamine and strength training program
Three times per week, standardized and supervised resistance training by physicians will be conducted at the National Institute of Rehabilitation for 6 weeks of follow up. At the beginning and at the end of the training session, the experimental group will receive by mouth 10 grams of glutamine dissolved in 120 milliliters of water, all participants and team of researchers will not be aware of the supplement.
Glutamine
At the beginning and at the end of the training session, the experimental group will receive by mouth 15 grams of glutamine dissolved in 120 milliliters of water. The aminoacid will be inside gray envelopes.
Strength training program
One training session consists of 20 minutes of warm-up, 40 to 60 minutes of aerobic and anaerobic exercises and 15 minutes of cooling down. The exercises of the lower part of the body consist in 3 sets of 10 repetitions for healthy knee, and 12 repetitions for knee with anterior cruciate ligament reconstruction in a modular leg press, leg curl and leg extension machine.
Dietary recommendations
All participants, irrespective of the supplement that they receive, will be closely monitored by a nutritionist, who will give dietary recommendations to standardize protein consumption (1.2 gr/kg weight). Status nutritional will be assessed according to BMI ( 19.9-24.9, 25-29.9).
Placebo and strength training program
Three times per week a standardized and supervised resistance training by physicians will be conducted at the National Institute of Rehabilitation for 6 weeks after discharge. At the beginning and at the end of the training session, the placebo group will receive by mouth10 grams of maltodextrin dissolved in 120 milliliters of water. All participants and team of researchers will not be aware of the supplement content.
Strength training program
One training session consists of 20 minutes of warm-up, 40 to 60 minutes of aerobic and anaerobic exercises and 15 minutes of cooling down. The exercises of the lower part of the body consist in 3 sets of 10 repetitions for healthy knee, and 12 repetitions for knee with anterior cruciate ligament reconstruction in a modular leg press, leg curl and leg extension machine.
Placebo
Maltodextrin powder to mimic glutamine,
Dietary recommendations
All participants, irrespective of the supplement that they receive, will be closely monitored by a nutritionist, who will give dietary recommendations to standardize protein consumption (1.2 gr/kg weight). Status nutritional will be assessed according to BMI ( 19.9-24.9, 25-29.9).
Interventions
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Glutamine
At the beginning and at the end of the training session, the experimental group will receive by mouth 15 grams of glutamine dissolved in 120 milliliters of water. The aminoacid will be inside gray envelopes.
Strength training program
One training session consists of 20 minutes of warm-up, 40 to 60 minutes of aerobic and anaerobic exercises and 15 minutes of cooling down. The exercises of the lower part of the body consist in 3 sets of 10 repetitions for healthy knee, and 12 repetitions for knee with anterior cruciate ligament reconstruction in a modular leg press, leg curl and leg extension machine.
Placebo
Maltodextrin powder to mimic glutamine,
Dietary recommendations
All participants, irrespective of the supplement that they receive, will be closely monitored by a nutritionist, who will give dietary recommendations to standardize protein consumption (1.2 gr/kg weight). Status nutritional will be assessed according to BMI ( 19.9-24.9, 25-29.9).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate loss of muscle strength of knee (assessment with computerized dynamometer)
* Perform the training sessions in the hospital
* No athletes
* Index Body Mass: 20 - 30 kg/m²
* Without consumption of supplements based on amino acids in the last 6 months
* To sign informed consent letter
Exclusion Criteria
* Liver and renal diseases
* Dyslipidemia
* Glucocorticoid consumption
* Active cancer
* Glutamine allergy or intolerance
* Planning to lose weight/go on special diet
20 Years
50 Years
MALE
No
Sponsors
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Universidad Nacional Autonoma de Mexico
OTHER
Instituto Nacional de Rehabilitacion
OTHER_GOV
Responsible Party
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Sandra Hernández Valencia
Principal investigator
Principal Investigators
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Laura Moreno Altamirano, PhD
Role: STUDY_DIRECTOR
Universidad Nacional Autonoma de Mexico
Locations
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Instituto Nacional de Rehabilitación
Mexico City, , Mexico
Countries
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References
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Nordenvall R, Bahmanyar S, Adami J, Mattila VM, Fellander-Tsai L. Cruciate ligament reconstruction and risk of knee osteoarthritis: the association between cruciate ligament injury and post-traumatic osteoarthritis. a population based nationwide study in Sweden, 1987-2009. PLoS One. 2014 Aug 22;9(8):e104681. doi: 10.1371/journal.pone.0104681. eCollection 2014.
Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797.
Adams D, Logerstedt DS, Hunter-Giordano A, Axe MJ, Snyder-Mackler L. Current concepts for anterior cruciate ligament reconstruction: a criterion-based rehabilitation progression. J Orthop Sports Phys Ther. 2012 Jul;42(7):601-14. doi: 10.2519/jospt.2012.3871. Epub 2012 Mar 8.
Hsiao SF, Chou PH, Hsu HC, Lue YJ. Changes of muscle mechanics associated with anterior cruciate ligament deficiency and reconstruction. J Strength Cond Res. 2014 Feb;28(2):390-400. doi: 10.1519/JSC.0b013e3182986cc1.
Thomas AC, Villwock M, Wojtys EM, Palmieri-Smith RM. Lower extremity muscle strength after anterior cruciate ligament injury and reconstruction. J Athl Train. 2013 Sep-Oct;48(5):610-20. doi: 10.4085/1062-6050-48.3.23. Epub 2013 Apr 18.
Zuka-Nowak K, Ogrodzka K, Chwala W, Niedzwiedzki L, Niedzwiedzki T. Kinetic and kinematic characteristics of natural velocity gait in anterior cruciate ligament-deficient patients. Int J Rehabil Res. 2013 Jun;36(2):152-61. doi: 10.1097/MRR.0b013e32835c79c5.
Orri JC, Darden GF. Technical report: Reliability and validity of the iSAM 9000 isokinetic dynamometer. J Strength Cond Res. 2008 Jan;22(1):310-7. doi: 10.1519/JSC.0b013e31815fa2c8.
Risberg MA, Lewek M, Snyder-MacKler L. A systematic review of evidence for anterior cruciate ligament rehabilitation: how much and what type?. Phys Ther Sport (5): 125-145, 2004
Trees AH, Howe TE, Dixon J, White L. Exercise for treating isolated anterior cruciate ligament injuries in adults. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD005316. doi: 10.1002/14651858.CD005316.pub2.
Eitzen I, Moksnes H, Snyder-Mackler L, Risberg MA. A progressive 5-week exercise therapy program leads to significant improvement in knee function early after anterior cruciate ligament injury. J Orthop Sports Phys Ther. 2010 Nov;40(11):705-21. doi: 10.2519/jospt.2010.3345.
Cermak NM, Res PT, de Groot LC, Saris WH, van Loon LJ. Protein supplementation augments the adaptive response of skeletal muscle to resistance-type exercise training: a meta-analysis. Am J Clin Nutr. 2012 Dec;96(6):1454-64. doi: 10.3945/ajcn.112.037556. Epub 2012 Nov 7.
Pasiakos SM, McLellan TM, Lieberman HR. The effects of protein supplements on muscle mass, strength, and aerobic and anaerobic power in healthy adults: a systematic review. Sports Med. 2015 Jan;45(1):111-31. doi: 10.1007/s40279-014-0242-2.
Holm L, Esmarck B, Mizuno M, Hansen H, Suetta C, Holmich P, Krogsgaard M, Kjaer M. The effect of protein and carbohydrate supplementation on strength training outcome of rehabilitation in ACL patients. J Orthop Res. 2006 Nov;24(11):2114-23. doi: 10.1002/jor.20147.
Eichner ER. Glutamine supplementation: overstaying its welcome. Curr Sports Med Rep. 2013 Jul-Aug;12(4):211-2. doi: 10.1249/JSR.0b013e31829b54c8. No abstract available.
Mason BC, Lavallee ME. Emerging supplements in sports. Sports Health. 2012 Mar;4(2):142-6. doi: 10.1177/1941738111428127.
Agostini F, Biolo G. Effect of physical activity on glutamine metabolism. Curr Opin Clin Nutr Metab Care. 2010 Jan;13(1):58-64. doi: 10.1097/MCO.0b013e328332f946.
Piattoly T, Parish TR, Welsch MA. L-Glutamine Supplementation: effects on endurance, power and recovery. Curr Top Nutraceutical Res 11(1-2): 55-62, 2013.
Hernandez Valencia SE, Mendez Sanchez L, Clark P, Moreno Altamirano L, Mejia Arangure JM. [GLUTAMINE AS AN AID IN THE RECOVERY OF MUSCLE STRENGTH: SYSTEMATIC REVIEW OF LITERATURE]. Nutr Hosp. 2015 Oct 1;32(4):1443-53. doi: 10.3305/nh.2015.32.4.9321. Spanish.
Legault Z, Bagnall N, Kimmerly DS. The Influence of Oral L-Glutamine Supplementation on Muscle Strength Recovery and Soreness Following Unilateral Knee Extension Eccentric Exercise. Int J Sport Nutr Exerc Metab. 2015 Oct;25(5):417-26. doi: 10.1123/ijsnem.2014-0209. Epub 2015 Mar 26.
Waddell D Fredricks K. Effects of a Glutamine Supplement on the Skeletal Muscle Contractile Force of Mice. Am J Undergraduate Res 4:11-18, 2005.
Other Identifiers
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47/16
Identifier Type: -
Identifier Source: org_study_id
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