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Evaluation of Efficacy and Tolerance of a Food Supplement (MYOSTIM®) in Postoperative Revalidation of Patients After Reconstructive Surgery of Anterior Cruciate Ligament

ClinicalTrials.gov · COMPLETED, 2017

35 participants

Abstract

Evaluation of efficacy and tolerance of a food supplement (MYOSTIM®) versus a placebo in postoperative revalidation of patients after reconstructive surgery of anterior cruciate ligament.

The food supplement (MYOSTIM®) has been developped and is supplied as food bars and composed of pomegranate, leucine, creatine, proteins and D vitamin. The aim of this exploratory study is to assess the efficacy and tolerance of MYOSTIM® on muscle performance after ACL reconstructive surgery and in postoperative revalidation phase.

Conditions: Anterior Cruciate Ligament Rupture.

Primary outcome: Assess the efficacy of MYOSTIM® on the muscular strength recovery; Assess the efficacy of MYOSTIM® on the muscular strength recovery; Assess the efficacy of MYOSTIM® on the muscular mass recovery; Assess the efficacy of MYOSTIM® on the muscular mass recovery; Assess the efficacy of MYOSTIM® on physical performance recovery; Assess the effect of MYOSTIM® on blood biomarker; Assess the efficacy of MYOSTIM® on the pain of the patient; Assess the efficacy of MYOSTIM® on the global judgment of the patient; Assessment of the tolerance of the patient with the MYOSTIM®; Assessment of the compliance of the patient with the MYOSTIM®; Assessment of the satisfaction of the patient with the MYOSTIM®.

Enrollment: 35 participants.

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 35 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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