Session Information
Date: Thursday, June 8, 2017
Session Title: Clinical Trials and Therapy in Movement Disorders
Session Time: 1:15pm-2:45pm
Location: Exhibit Hall C
Objective: Objective. To evaluate whether the use of a whey protein-based nutritional formula enriched with essential aminoacids – particularly leucine – and vitamin D have a beneficial effect on functional exercise-based rehabilitation.
Background: Background. Physical rehabilitation is an important strategy for treating motor disability in patients suffering from Parkinson’s disease (PD) or parkinsonism. Muscle dysfunction is highly prevalent in this patient population and previous studies in old adults have shown that the outcome of exercise-based treatments may be positively influenced by concomitant nutritional support.
Methods: Patients and Methods. We designed a randomized, controlled trial. Patients suffering from PD or parkinsonism and scheduled for a multidisciplinary intensive rehabilitation treatment will be randomized (1:1) to receive standard hospital diet with or without a vitamin D and leucine-enriched whey protein nutritional supplement to consume twice daily for 30 days. The primary efficacy end point will be the increase in the distance walked during a 6-minute walking test. Secondary outcome variables will be: timed up and go test, Berg balance scale, 4-meter walking speed, Self-assessment Parkinson’s Disease Disability Scale and body composition (muscle mass).
Results: Results. In absence of preliminary data on this topic, considering an effect size of 0.5 (clinically meaningful according to Cohen), the sample size sufficient to have a power of 80% to detect a significant difference in the primary outcome measure with a two-tailed type-I error of 5%, we would need at least 64 patients per group. After assuming 10% withdrawal, we planned to enroll 140 patients (70 per treatment group).
Conclusions: Conclusion. Positive data from this trial would offer an effective adjuvant treatment options for patients with PD or parkinsonism undergoing a multidisciplinary intensive rehabilitation treatment.
References: 1. Barichella M, Cereda E, Cassani E, Pinelli G, Iorio L, Ferri V, Privitera G, Pasqua M, Valentino A, Monajemi F, Caronni S, Lignola C, Pusani C, Bolliri C, Faierman SA, Lubisco A, Frazzitta G, Petroni ML, Pezzoli G. Dietary habits and neurological features of Parkinson’s disease patients: Implications for practice. Clin Nutr. 2016 Jul 5. pii: S0261-5614(16)30155-8.
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To cite this abstract in AMA style:
m. barichella, E. Cereda, G. Pinelli, l. Iorio, V. Ferri, g. Frazzitta, E. Cassani, G. Riboldazzi, G. Pezzoli. Rehabilitation program with or without a whey protein-based nutritional support enriched with essential aminoacids and vitamin D in patients with Parkinson’s disease or parkinsonism: study design of a randomized, controlled trial. [abstract]. Mov Disord. 2017; 32 (suppl 2). https://www.mdsabstracts.org/abstract/rehabilitation-program-with-or-without-a-whey-protein-based-nutritional-support-enriched-with-essential-aminoacids-and-vitamin-d-in-patients-with-parkinsons-disease-or-parkinsonism-study-des/. Accessed December 11, 2024.« Back to 2017 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/rehabilitation-program-with-or-without-a-whey-protein-based-nutritional-support-enriched-with-essential-aminoacids-and-vitamin-d-in-patients-with-parkinsons-disease-or-parkinsonism-study-des/