Can we add whey protein supplementation in patients with Parkinson's disease without interfering with levodopa response?

OBJECTIVE: The main endpoint of the study was to evaluate if a daily intake of whey protein-based dietary supplement causes a worse response to levodopa in people with Parkinson's Disease (PWPD). BACKGROUND: In PWPD, the competition between large neutral aminoacids and levodopa at intestinal absorption level may interfere with dopaminergic therapy's (DRT) effect; therefore, protein redistribution dietary regimen has been suggested. Many dietary supplementations are available to help people in balancing the protein intake and overcoming muscle mass loss. However, most of the products contain protein and could potentially affect levodopa action in PWPD. METHODS: We performed a randomised single blind monocentric study on PWPD admitted in the rehabilitative unit for a 4-week multidisciplined intensive aerobic rehabilitation treatment. All patients received a standard protein redistribution dietary regimen plus a whey protein-based oral formula (N = 26) or Magnesium (N = 25) twice daily for 28 days. Neurological assessment and physical evaluation were conducted before (T0) and after (T1) rehabilitative treatment; DRT was recorded T0 and T1 as well. The delta of changes within groups in neurological (UPDRS III) and physical (TUG, 6 MW) evaluation scales was compared between groups. RESULTS: Groups were comparable at baseline in clinical and demographic data; at T1, both groups showed a decrease in UPDRS III, TUG and 6 MWT and no differences between deltas were found. DRT remained stable in both groups. CONCLUSIONS: Our results show that whey protein supplementation does not interfere with DRT's efficacy and can be used in PWPD who need a protein supplementation without restrictions in intake hours.

Effects of a Novel Amino Acid Formula on Nutritional and Metabolic Status, Anemia and Myocardial Function in Thrice-Weekly Hemodialysis Patients: Results of a Six-Month Randomized Double-Blind Placebo-Controlled Pilot Study.

(1) Background: Chronic Kidney Disease (CKD) induces metabolic derangement of amino acid (AA) kinetics, eliciting severe damage to the protein anabolism. This damage is further intensified by a significant loss of AAs through hemodialysis (HD), affecting all tissues with a high metabolic turnover, such as the myocardium and body muscle mass. (2) Aim: to illustrate the effects of a novel AA mixture in boosting mitochondrial energy production. (3) Methods: A strict selection of 164 dialysis patients was carried out, allowing us to finally identify 22 compliant patients who had not used any form of supplements over the previous year. The study design envisaged a 6-month randomized, double-blind trial for the comparison of two groups of hemodialysis patients: eleven patients (67.2 ± 9.5 years) received the novel AA mix (TRG), whilst the other eleven (68.2 ± 10.5 years) were given a placebo mix that was indistinguishable from the treatment mix (PLG). (4) Results: Despite the 6-month observation period, the following were observed: maintenance of target hemoglobin values with a reduced need for erythropoiesis-stimulating agents in TRG > 36% compared to PLG (p < 0.02), improved phase angle (PhA) accompanied by an increase in muscle mass solely in the TRG group (p < 0.05), improved Left Ventricular Ejection Fraction (LVEF > 67%) in the TRG versus PLG group (p < 0.05) with early but marked signs of improved diastolic function. Increased sensitivity to insulin with greater control of glycemic levels in TRG versus PLG (p = 0.016). (5) Conclusions: the new AA mix seemed to be effective, showing a positive result on nutritional metabolism and cardiac performance, stable hemoglobin levels with the need for lower doses of erythropoietin (EPO), insulin increased cell sensitivity, better muscle metabolism with less loss of mass.

Essential amino acid supplementation is associated with reduced serum C-reactive protein levels and improved circulating lymphocytes in post-acute inflamed elderly patients.

BACKGROUND: Persistent systemic inflammation leads to multidistrectual body dysfunctions. Attenuation of inflammation may improve patients' functional and life prognoses. We hypothesized that essential amino acids (EAAs) given to elderly patients in rehabilitation after acute diseases may be associated with a reduced inflammatory state. Therefore, this retrospective study investigated whether the supplementation of EAAs - modulators of immune competence - was associated with a reduced inflammation rate in elderly patients. METHODS: The medical records of 282 patients admitted to the rehabilitation (rehab) institute after acute index events (surgery or medical diseases) (age: 81.18 ± 8.58 years; females: 67.9%) were analyzed. RESULTS: 46 patients (16.3% of the entire population) had received EAA supplements (S), whereas the remaining 236 patients had not (N-S). Systemic inflammation (I) (serum C-reactive protein (CRP) > 0.5 mg/dL) was present in 67.4% of the I-S group and 57.2% of the I-N-S group. During rehab, the I-S group (but not the I-N-S group) showed a reduction in CRP levels (p = 0.03) and an increase in circulating lymphocytes (p = 0.035), immune cells of the adaptive immune system. C-reactive protein levels remained virtually unchanged in non-inflamed patients who received supplements but increased in non-inflamed patients who did not receive supplements (p = 0.05). Stratified for developed infections, CRP levels reduced in S patients (p = 0.008) but did not in N-S patients. CONCLUSION: EAA supplementation was associated with reduced inflammation in both inflamed and infected patients. In addition, EAA supplementation was associated with increased circulating lymphocytes in inflamed patients.

Effectiveness of aquatic versus land physiotherapy in the treatment of peripheral neuropathies: a randomized controlled trial.

OBJECTIVE: To compare the effects on gait and balance of aquatic physiotherapy versus on-land training, in the context of an inpatient rehabilitation treatment tailored for peripheral neuropathies. DESIGN: Parallel-group, single-center, single-blind randomized controlled trial. SUBJECTS AND SETTING: Consecutive patients affected by peripheral neuropathy admitted in our Neuro-Rehabilitation Unit. INTERVENTIONS: Patients received a four-week rehabilitation program composed by daily sessions of conventional physiotherapy and three sessions/week of specific treatment (aquatic vs. on-land). MAIN MEASURES: Primary outcome measures were Berg Balance Scale and Dynamic Gait Index. Secondary outcome measures were Neuropathic Pain Scale, Overall Neuropathy Limitations Scale, Functional Independence Measure, Functional Ambulation Classification, Conley Scale and Medical Research Council Scale score for the strength of hip and ankle flexor and extensor muscles. For each scale, we calculated the difference between the scores at discharge and admission and compared it between the two groups. RESULTS: Forty patients were enrolled: 21 in the water-based rehabilitation group and 19 in the land-based one. Patients were similar between groups. When comparing the groups, we found that "in-water" patients had a significant better improvement in the Dynamic Gait Index score (6.00 (4.00, 7.25) vs. 4.00 (1.25, 6.00), P = 0.0433). On the opposite, the "on-land" group showed a better improvement of the Functional Ambulation Classification score (1.0 (0.75, 1.0) vs. 1.0 (1.0, 2.0), P = 0.0386). CONCLUSION: Aquatic physiotherapy showed an effect comparable to the land-based rehabilitation on gait and balance dysfunctions of neuropathic patients.

Rehabilitation of hypomimia in Parkinson's disease: a feasibility study of two different approaches.

Parkinson's disease (PD) patients frequently have an impairment of facial expression both in voluntary and spontaneous emotional expression. Aim of this study was to evaluate the feasibility of a rehabilitation program for hypomimia in patients with PD, comparing two different approaches. Thirty-six patients with PD were included: 20 patients received a rehabilitative intervention for hypomimia either with a DVD showing exercises focused on facial muscles (PD-group-A) or with a therapist-guided facial rehabilitation with a proprioceptive/recognition approach (PD-group-B). Sixteen patients (PD-Ctrl group) did not receive any treatment and served as control group. The feasibility of the proposed rehabilitation techniques was the main focus of this evaluation. We also evaluate the efficacy of the treatments by means of the sub-item 19 of the Unified Parkinson's disease Rating Scale motor score (UPDRS-III) and by a computerized analysis of facial expression (E-Motion), which was assessed prior to (T0) and after therapy (T1). The proposed rehabilitative program for the treatment of hypomimia was shown to be feasible. Our data show a significant improvement in UPDRS-III sub-item 19 in PD-group-B compared to PD-group-A, (p = 0.005) and to PD-Ctrl (p = 0.003) and in expressivity of fear in PD-group-B compared to PD-Ctrl (p = 0.01). The proposed rehabilitative program showed to be feasible. A larger multi-center trial is now warranted to establish its efficacy to improve facial expression over long time period.

Medicinal clays improve the endurance of loaded inspiratory muscles in COPD: a randomized clinical trial of nonpharmacological treatment.

BACKGROUND: Inspiratory resistive breathing (IRB) challenges affect respiratory muscle endurance in healthy individuals, which is considered to be an interleukin 6 (IL-6)-dependent mechanism. Whether nonpharmacological thermal therapies promote the endurance of loaded inspiratory muscles in chronic obstructive pulmonary disease (COPD) is unclear. The objectives of this study were to compare the effects of two thermal interventions on endurance time (ET) and plasma IL-6 concentration following an IRB challenge. METHODS: This study was a randomized, parallel-group, unblinded clinical trial in a single-center setting. Forty-two patients (aged 42-76 years) suffering from mild to severe COPD participated in this study. Both groups completed 12 sessions of the mud bath therapy (MBT) (n=22) or leisure thermal activity (LTA) (n=19) in a thermal spa center in Italy. Pre- and postintervention spirometry, maximum inspiratory pressure, and plasma mediators were obtained and ET and endurance oxygen expenditure (VO2Endur) were measured following IRB challenge at 40% of maximum inspiratory pressure. RESULTS: There was no difference in ΔIL-6 between the intervention groups. But, IRB challenge increased cytokine IL-6 plasma levels systematically. The effect size was small. A statistically significant treatment by IRB challenge effect existed in ET, which significantly increased in the MBT group (P=0.003). In analysis of covariance treatment by IRB challenge analysis with LnVO2Endur as the dependent variable, ΔIL-6 after intervention predicted LnVO2Endur in the MBT group, but not in the LTA group. Adverse events occurred in two individuals in the MBT group, but they were mainly transient. One patient in the LTA group dropped out. CONCLUSION: MBT model improves ET upon a moderate IRB challenge, indicating the occurrence of a training effect. The LnVO2Endur/ΔIL-6 suggests a physiologic adaptive mechanism in respiratory muscles of COPD patients allocated to treatment. Both thermal interventions are safe.

Comparing the effects of hydrotherapy and land-based therapy on balance in patients with Parkinson's disease: a randomized controlled pilot study.

OBJECTIVE: Our aim was to evaluate the feasibility of a hydrotherapy treatment in patients with Parkinson's disease and the effectiveness of this treatment on balance parameters in comparison to a traditional land-based physical therapy. DESIGN: A randomized single-blind controlled trial. SETTING: Outpatients. SUBJECTS: Thirty-four patients with Parkinson's disease in Hoehn-Yahr stage 2.5-3. INTERVENTION: Group 1 hydrotherapy treatment, group 2 land-based rehabilitation treatment. The two groups underwent the same rehabilitation period (60 minutes of treatment, five days a week for two months). MAIN MEASURES: The primary outcome measures were the centre of the pressure sway area recorded with open and closed eyes, using a stabilometric platform. Secondary outcome measures were Unified Parkinson's Disease Rating Scale II and III, Timed Up and Go Test, Berg Balance Scale, Activities-specific Balance Confidence Scale, Falls Efficacy Scale, Falls diary and Parkinson's Disease Questionnaire-39. RESULTS: Hydrotherapy treatment proved to be feasible and safe. Patients in both groups had a significant improvement in all outcome variables. There was a better improvement in patients who underwent hydrotherapy than in patients treated with land-based therapy in the centre of pressure sway area closed eyes (mean SD change: 45.4 SD64.9 vs. 6.9 SD45.3, p = 0.05), Berg Balance Scale (51.2 SD3.1 vs. 6.0 SD3.1, p = 0.005), Activities-specific Balance Confidence Scale (16.8 SD10.6 vs. 4.1 SD5.4, p = 0.0001), Falls Efficacy Scale (-5.9 SD4.8 vs. -1.9 SD1.4, p = 0.003), Parkinson's Disease Quetionnaire-39 (-18.4 SD12.9 vs. -8.0 SD7.0, p = 0.006) and falls diary (-2.4 SD2.2 vs. -0.4 SD0.5, p = 0.001). CONCLUSION: Our study suggests that hydrotherapy may constitute a possible treatment for balance dysfunction in Parkinsonian patients with moderate stage of disease.

n-3PUFA and Holter-derived autonomic variables in patients with heart failure: data from the Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza Cardiaca (GISSI-HF) Holter substudy.

BACKGROUND: n-3 Polyunsaturated fatty acid (n-3PUFA) supplementation in the Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza Cardiaca (GISSI-HF) study reduced total mortality in patients with heart failure (HF), but the mechanism of action is still debated. The hypothesis of the present GISSI-HF substudy was that n-3PUFA may have beneficial effects on cardiac autonomic control. OBJECTIVE: To evaluate the effect of 1 g/day of n-3PUFA vs placebo on heart rate variability variables, deceleration capacity, and turbulence slope. METHODS: The GISSI-HF study enrolled patients with HF of any cause and severity. Twenty-four-hour (range 16-24 hours) Holter recordings were performed and analyzed in 388 patients at baseline, 3 months, and 12 months. Baseline characteristics were compared by using the χ(2) test, t test, or nonparametric Wilcoxon 2-sample test. Changes over time were tested by using the analysis of covariance adjusted by baseline values. RESULTS: At baseline, 36% of the patients were older than 70 years, 82% were men, 92% presented a left ventricular ejection fraction<40%, and 80% were in New York Heart Association class II. An increase in mean RR interval, standard deviation of all normal-to-normal RR intervals, very low frequency power (all P<.05), and turbulence slope (P = .05) was observed after 3 months in the n-3PUFA group compared to the placebo group, independently of the frequency of dietary fish consumption or beta-blocker treatment. These differences between study groups were no longer statistically significant at 12 months. A per-protocol analysis in patients compliant with study treatment showed similar results. CONCLUSIONS: n-3PUFA supplementation partially restored autonomic modulation in patients with chronic HF; this effect was maximal after 3 months of treatment.

Autonomic markers and cardiovascular and arrhythmic events in heart failure patients: still a place in prognostication? Data from the GISSI-HF trial.

AIMS: To investigate the prognostic value of autonomic variables in patients with symptomatic chronic heart failure (HF) treated according to current recommendations. METHODS AND RESULTS: We analysed 24 h time-domain [standard deviation of all normal-to-normal RR intervals (SDNN)], frequency-domain [very low frequency and low frequency power (VFLP and LFP)], and non-linear [detrended fluctuation analysis (DFA)] heart rate variability, deceleration capacity (DC), and heart rate turbulence (HRT) in 388 sinus rhythm HF patients enrolled in the GISSI-HF Holter substudy [82% males, age 65 ±10 years, New York Heart Association (NYHA) functional class III-IV 20%, left ventricular ejection fraction (LVEF) 33 ±8%]. Cardiovascular (CV) mortality and combined sudden death + implantable cardioverter defibrillator (ICD) discharge were assessed as a function of continuous variables in the entire population and in patients with LVEF >30% in univariate and multivariable Cox proportional hazards models. After a median of 47 months, 57 patients died of CV causes and 47 experienced the arrhythmic endpoint. For CV mortality, VLFP, LFP, and turbulence slope (TS) improved predictive discrimination (c-index) and risk classification [integrated discrimination improvement (IDI)] when added to clinical variables [age ≥70 years, LVEF, non-sustained ventricular tachycardia (NSVT), serum creatinine], while for arrhythmic mortality although the c-index increased in all three autonomic markers, the results of the IDI were statistically significant only for TS when added to NSVT, serum creatinine, and ischaemic aetiology. In 194 patients with LVEF >30% (20 arrhythmic events), the hazard ratio of an impaired TS (<2.5 msper RR interval) was 3.81 (95% confidence interval 1.35-10.7,P = 0.012) after adjustment for serum creatinine. CONCLUSIONS: Autonomic indexes still have independent predictive value on long-term outcome in HF patients. HRT may help in identifying patients with LVEF >30% at increased arrhythmic risk. Trial registration NCT00336336.

Effectiveness of intensive inpatient rehabilitation treatment on disease progression in parkinsonian patients: a randomized controlled trial with 1-year follow-up.

BACKGROUND: Rehabilitation treatments have acute beneficial effects in Parkinson's disease (PD) patients, but whether the effects persist over time is unclear. OBJECTIVE: To assess whether an intensive rehabilitation treatment (IRT) is effective in improving motor performance compared with a control group in a 12-month follow-up, to investigate whether a second cycle administered after 1 year has the same efficacy as the first treatment, and to determine whether IRT reduces the need for increasing levodopa dosage. METHODS: A total of 50 PD patients were randomly assigned to 2 groups; 25 participants had 4 weeks of inpatient physical therapy that included treadmill and stabilometric platform training. At discharge, these patients were invited to continue doing the learned exercises. After 12 months, the same treatment was repeated. The control group of 25 patients received only pharmacological treatment and was invited to practice generic physical exercise at home. The rating scales used for the clinical evaluation were the Unified Parkinson's Disease Rating Scale Sections II and III (UPDRS II and III) and total (UPDRS tot). RESULTS: The authors found that the beneficial effects of IRT persisted over time. A second rehabilitation cycle administered after 1 year was as effective as the first treatment. At the end of the study, daily medication dosage was reduced in treated patients, whereas it was significantly increased in control patients. CONCLUSION: These findings suggest that the natural worsening of symptoms associated with PD can be effectively counteracted by a properly designed IRT.

Rehabilitation: Periodic somatosensory stimulation increases arterial baroreflex sensitivity in chronic heart failure patients.

BACKGROUND: One of the beneficial effects of exercise training in chronic heart failure (CHF) is an improvement in baroreflex sensitivity (BRS), a prognostic index in CHF. In our hypothesis-generating study we propose that at least part of this effect is mediated by neural afferent information, and more specifically, by exercise-induced somatosensory nerve traffic. OBJECTIVE: To compare the effects of periodic electrical somatosensory stimulation on BRS in patients with CHF with the effects of exercise training and with usual care. METHODS: We compared in stable CHF patients the effect of transcutaneous electrical nerve stimulation (TENS, N = 23, LVEF 30 ± 9%) with the effects of bicycle exercise training (EXTR, N = 20, LVEF 32 ± 7%). To mimic exercise-associated somatosensory ergoreceptor stimulation, we applied periodic (2/s, marching pace) burst TENS to both feet. TENS and EXTR sessions were held during two successive days. RESULTS: BRS, measured prior to the first intervention session and one day after the second intervention session, increased by 28% from 3.07 ± 2.06 to 4.24 ± 2.61 ms/mmHg in the TENS group, but did not change in the EXTR group (baseline: 3.37 ± 2.53 ms/mmHg; effect: 3.26 ± 2.54 ms/mmHg) (P(TENS vs EXTR) = 0.02). Heart rate and systolic blood pressure did not change in either group. CONCLUSIONS: We demonstrated that periodic somatosensory input alone is sufficient and efficient in increasing BRS in CHF patients. This concept constitutes a basis for studies towards more effective exercise training regimens in the diseased/impaired, in whom training aimed at BRS improvement should possibly focus more on the somatosensory aspect.

Rehabilitation treatment of gait in patients with Parkinson's disease with freezing: a comparison between two physical therapy protocols using visual and auditory cues with or without treadmill training.

Freezing is a disabling symptom in patients with Parkinson's disease. We investigated the effectiveness of a new rehabilitation strategy based on treadmill training associated with auditory and visual cues. Forty Parkinsonian patients with freezing were randomly assigned to two groups: Group 1 underwent a rehabilitation program based on treadmill training associated with auditory and visual cues, while Group 2 followed a rehabilitation protocol using cues and not associated with treadmill. Functional evaluation was based on the Unified Parkinson's Disease Rating Scale Motor Section (UPDRS III), Freezing of Gait Questionnaire (FOGQ), 6-minute walking test (6MWT), gait speed, and stride cycle. Patients in both the groups had significant improvements in all variables considered by the end of the rehabilitation program (all P = 0.0001). Patients treated with the protocol including treadmill, had more improvement than patients in Group 2 in most functional indicators (P = 0.007, P = 0.0004, P = 0.0126, and P = 0.0263 for FOGQ, 6MWT, gait speed, stride cycle, respectively). The most striking result was obtained for 6MWT, with a mean increase of 130 m in Group 1 compared with 57 m in Group 2. Our results suggest that treadmill training associated with auditory and visual cues might give better results than more conventional treatments. Treadmill training probably acts as a supplementary external cue.