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Muscle-targeted nutritional support for rehabilitation in patients with parkinsonian syndrome
Michela Barichella1, Emanuele Cereda2, Giovanna Pinelli1
1From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.
Objective:
We evaluated the efficacy of muscle-targeted nutritional support on the functional outcomes of multidisciplinary intensive rehabilitation treatment (MIRT) in patients with Parkinson disease (PD) or parkinsonism.
Methods:
We conducted a pragmatic, bicentric, randomized (1:1), assessor-blind controlled trial (Protein, Leucine and Vitamin D Enhancing Rehabilitation [PRO-LEADER]; April 2017 to January 2018) in cognitively intact patients with PD or parkinsonism and undergoing a 30-day MIRT. Patients (n = 150) received a standard hospital diet with or without a whey protein-based nutritional supplement enriched with leucine and vitamin D twice daily. The primary efficacy endpoint was the increase in the distance walked during a 6-minute walking test (6MWT). Secondary endpoints were changes in 4-meter walking speed, Timed Up and Go test (TUG), Berg balance scale, handgrip strength, Self-assessment Parkinson's Disease Disability Scale, body weight, and skeletal muscle mass (SMM).
Results:
Nutritional support resulted in greater increase in the distance walked during 6MWT (mean 69.6 meters [95% confidence interval (CI) 60.7-78.6]) than no support (51.8 meters [95% CI 37.0-66.7]): center-adjusted mean difference, 18.1 meters (95% CI 0.9-35.3) (p = 0.039). Further adjustment for changes in dopaminergic therapy and SMM yielded consistent results: mean difference, 18.0 meters (95% CI 0.7-35.2) (p = 0.043). A meaningful effect was also found for the following secondary endpoints: 4-meter walking speed (p = 0.032), TUG (p = 0.046), SMM, and SMM index (p = 0.029). Six patients discontinued the nutritional therapy due to mild side effects.
Conclusion:
The consumption of a whey protein-based nutritional formula enriched with leucine and vitamin D with MIRT improved lower extremity function and preserved muscle mass in patients with PD or parkinsonism.Clinicaltrials.gov IDENTIFIER: NCT03124277.
Classification Of Evidence:
This study provides Class I evidence that for patients with parkinsonism undergoing intensive rehabilitation, a whey protein-based nutritional formula enriched with leucine and vitamin D increased distance walked on the 6MWT.
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