The VENERE Study: EffectiVenEss of a Rehabilitation Treatment With Nordic Walking in ObEse or OveRweight Diabetic PatiEnts With Cardiovascular Disease.

Background: Nordic walking (NW) has several potential benefits for individuals with cardiovascular (CV) disease, type 2 diabetes, and obesity and/or overweight. NW improves cardiovascular health, including exercise capacity and blood pressure control. NW enhances glycemic control and insulin sensitivity in diabetes, and aids in weight management and body composition improvement. NW offers additional advantages, such as improvement in muscular strength, joint mobility, physical activity levels, and psychological well-being. Methods: This open-label study with 3 arms will aim to evaluate the efficacy, safety, and adherence to exercise prescription in obese and/or overweight diabetic patients with CV complications. The primary objective will be to assess the CV performance of participants after a 6-month and a 12-month follow-up period, following a 3-month NW intervention, compared with standard rehabilitation, and with cardiological counseling (control group) training lasting 3 months. Results: The results of the study will provide valuable insights into the comparative effectiveness of a NW intervention vs standard rehabilitation and control group training in improving CV performance in obese and/or overweight diabetic patients with CV complications. Additionally, safety and adherence data will help inform the feasibility and sustainability of the exercise prescription over an extended period. Conclusions: These findings may have implications for the development of tailored exercise programs for this specific patient population, with the aim of optimizing CV health outcomes. Clinical Trials Registration: NCT05987410.

Contexte: La marche nordique offre plusieurs bienfaits potentiels aux personnes atteintes d'une maladie cardiovasculaire (CV), de diabète de type 2, de surpoids ou d'obésité. Elle améliore la santé cardiovasculaire, notamment l'endurance à l'effort et la régulation de la pression artérielle, en plus de favoriser l'équilibre glycémique et d'accroître la sensibilité à l'insuline chez les personnes diabétiques. Elle facilite également la gestion du poids et l'amélioration de la composition corporelle. Par ailleurs, la marche nordique présente d'autres avantages, comme l'augmentation de la force musculaire, de la mobilité articulaire, du niveau d'activité physique et du bien-être psychologique. Méthodologie: Cette étude ouverte à 3 groupes vise à évaluer l'efficacité, la sécurité et l'observance des exercices prescrits chez des sujets diabétiques obèses ou en surpoids présentant des complications CV. Le principal objectif consistera à évaluer la performance CV des participants au cours d'une période de suivi de 6 et 12 mois après un programme de marche nordique de 3 mois, comparativement à un programme de réadaptation standard et à un programme d'encadrement en soins CV (groupe témoin) de 3 mois. Résultats: Les résultats de l'étude fourniront de précieux renseignements sur l'efficacité d'un programme de marche rapide comparativement à un programme de réadaptation standard et à un programme d'encadrement (groupe témoin) pour améliorer la performance CV chez des sujets diabétiques obèses ou en surpoids présentant des complications CV. Les données relatives à la sécurité et à l'observance permettront également d'évaluer la faisabilité et la viabilité de la prescription d'exercices sur une longue période. Conclusions: Ces résultats pourraient s'avérer utiles dans l'élaboration de programmes d'exercices spécifiquement conçus pour cette population de patients, afin d'optimiser les résultats en santé CV. Numéro d'inscription de l'essai clinique: NCT05987410.

The Exercise aNd hEArt transplant (ENEA) trial - a registry-based randomized controlled trial evaluating the safety and efficacy of cardiac telerehabilitation after heart transplant.

BACKGROUND: Heart transplant (HTx) is gold-standard therapy for patients with end-stage heart failure. Cardiac rehabilitation (CR) is a multidisciplinary intervention shown to improve cardiovascular prognosis and quality of life. The aim in this randomized controlled trial is to explore the safety and efficacy of cardiac telerehabilitation after HTx. In addition, biomarkers of rehabilitation outcomes will be identified, as data that will enable treatment to be tailored to patient phenotype. METHODS: Patients after HTx will be recruited at IRCCS S. Maria Nascente - Fondazione Don Gnocchi, Milan, Italy (n = 40). Consenting participants will be randomly allocated to either of two groups (1:1): an intervention group who will receive on-site CR followed by 12 weeks of telerehabilitation, or a control group who will receive on-site CR followed by standard homecare and exercise programme. Recruitment began on 20th May 2023 and is expected to continue until 20th May 2025. Socio-demographic characteristics, lifestyle, health status, cardiovascular events, cognitive function, anxiety and depression symptoms, and quality of life will be assessed, as well as exercise capacity and muscular endurance. Participants will be evaluated before the intervention, post-CR and after 6 months. In addition, analysis of circulating extracellular vesicles using Surface Plasmon Resonance imaging (SPRi), based on a rehabilomic approach, will be applied to both groups pre- and post-CR. CONCLUSION: This study will explore the safety and efficacy of cardiac telerehabilitation after HTx. In addition, a rehabilomic approach will be used to investigate biomolecular phenotypization in HTx patients. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT05824364.

The Importance of the Diaphragm in Neuromotor Function in the Patient with Chronic Obstructive Pulmonary Disease.

Chronic obstructive pulmonary disease (COPD) is a constant and chronic narrowing of the respiratory airways, with numerous associated symptoms, not always related to the pathological adaptation of the lungs. Statistical projections show that COPD could become the third leading cause of death globally by 2030, with a significant increase in deaths by 2060. Skeletal muscle dysfunction, including the diaphragm, is one of the causes linked to the increase in mortality and hospitalization. Little emphasis is given by the scientific literature to the importance of the diaphragm towards functional neuromotor pathological expressions. The article reviews the adaptation of the skeletal muscles, with greater attention to the adaptations of the diaphragm, thereby highlighting the non-physiological variations that the main respiratory muscle undergoes and the neuromotor impairment found in COPD. The text could be an important reflection from a clinical and rehabilitation point of view, to direct greater attention to the function and adaptation of the diaphragm muscle.

Obstructive Sleep Apnea and Role of the Diaphragm.

Obstructive sleep apnea (OSA) causes multiple local and systemic pathophysiological consequences, which lead to an increase in morbidity and mortality in patients suffering from this disorder. OSA presents with various nocturnal events of apnoeas or hypopneas and with sub-clinical airflow limitations during wakefulness. OSA involves a large percentage of the population, particularly men, but the estimate of OSA patients could be much broader than data from the literature. Most of the research carried out in the muscle field is to understand the causes of the presence of chronic nocturnal desaturation and focus on the genioglossus muscle and other muscles related to dilating the upper airways. Sparse research has been published regarding the diaphragm muscle, which is the main muscle structure to insufflate air into the airways. The article reviews the functional anatomy of the muscles used to open the upper respiratory tract and the non-physiological adaptation that follows in the presence of OSA, as well as the functional anatomy and pathological adaptive aspects of the diaphragm muscle. The intent of the text is to highlight the disparity of clinical interest between the dilator muscles and the diaphragm, trying to stimulate a broader approach to patient evaluation.

Telerehabilitation Approaches for People with Chronic Heart Failure: A Systematic Review and Meta-Analysis.

INTRODUCTION: Telerehabilitation (TR) for chronic heart failure (CHF) allows for overcoming distance barriers and reducing exacerbations. However, little is known about TR descriptors, components, and efficacy in CHF. METHODS: This work systematically reviewed the TR strategies of randomized controlled trials in people with CHF. A meta-analysis was run to test its effect on exercise capacity and quality of life compared to no rehabilitation (NI) and conventional intervention (CI). RESULTS: Out of 6168 studies, 11 were eligible for the systematic review, and 8 for the meta-analysis. TR intervention was individual and multidimensional, with a frequency varying from 2 to 5 times per 8-12 weeks. The TR components mainly included an asynchronous model, monitoring/assessment, decision, and offline feedback. A few studies provided a comprehensive technological kit. Minimal adverse events and high adherence were reported. A large effect of TR compared to NI and a non-inferiority effect compared to CI was registered on exercise capacity, but no effects of TR compared to NI and CI on quality of life were observed. CONCLUSIONS: TR for people with CHF adopted established effective strategies. Future interventions may identify the precise TR dose for CHF, technological requirements, and engagement components affecting the patient's quality of life.

Short- and long-term effects of a cardiac rehabilitation program in patients implanted with a left ventricular assist device.

The efficacy of cardiac rehabilitation in heart-failure patients who received a left-ventricular assist device (LVAD) instead of heart transplantation (HTx) is still unclear. This study aims to evaluate whether cardiac rehabilitation is beneficial in LVAD as HTx patients in the short term and whether its effects in LVAD patients persist over time. Twenty-five LVAD patients were evaluated by functional and psychological tests at admission (T0) and discharge (T1) of a 4-week inpatient structured rehabilitation program, and follow-ups 3 (T2), 6 (T3), and 12 months (T4) after discharge. Twenty-five matched HTx patients were also studied from T0 to T1 to compare the improvements in the six-minute walk test (6MWT). The quality-of-life scores substantially improved in LVAD patients and the 6MWT showed the same functional recovery as in HTx patients from T0 to T1. After T1, numerous LVAD patients withdrew from the study. However, the 6MWT outcome increased further from T1 to T3, with a positive trend during the follow-ups. Hemoglobin and the ventilatory performance increased, and the psychological perception of heart-failure symptoms and pain further improved at T2. In conclusion, exercise-based rehabilitation programs provide similar beneficial effects in LVAD and HTx patients, without deterioration in LVAD patients up to 12 months after discharge.

Acute Fingolimod Effects on Baroreflex and Cardiovascular Autonomic Control in Multiple Sclerosis.

BACKGROUND: Fingolimod, an oral drug used in multiple sclerosis (MS) treatment, exerts its action through S1P-receptor engagement. These receptors are also expressed in heart and endothelial cells. The engagement of receptors on the atrial heart myocytes may cause a slowing effect on heart rate (HR). We aimed to explore the acute effect of fingolimod on the cardiac autonomic control, a side-effect of the drug that still needs to be clarified. METHODS: In 10 MS patients, we investigated the influence of the first administration of fingolimod (0.5 mg) on sympathetic and parasympathetic indexes via the analysis of the HR variability, and on the baroreflex sensitivity via sequence and alpha coefficient techniques. RESULTS: Fingolimod produced an average HR maximal drop of 12.7 (7.8) beats/min and the minimal HR occurred after 2.73 (0.38) hours from the dose administration. The pulse interval (PI) mean value and the pNN50 and RMSSD indexes of parasympathetic drive to the heart significantly increased. Interestingly, in 6 out of 10 patients also the power in the low-frequency band (LF) increased. The baroreflex sensitivity was not modified by the first dose of the drug. CONCLUSIONS: Our findings indicate that although the first dose of fingolimod invariably activates the parasympathetic system, in several subjects, it may induce also a surge in the sympathetic cardiac drive. This suggests that not only the vagal, as usually assumed, but also the sympathetic autonomic branch should be considered in the risk profile assessment of MS patients starting treatment with fingolimod.

The Anatomical Relationships of the Tongue with the Body System.

The tongue plays a fundamental role in several body functions such as swallowing, breathing, speaking, and chewing. Its action is not confined to the oral cavity, but it affects lower limb muscle strength and posture. The tongue is an organ that has an autocrine/paracrine mechanism of action to synthesize different substances to interact with the whole body; according to a line of thought, it is also an extension of the enteric system. The aim of this study was to review the functions of the tongue and its anatomical association with the body system. According to the authors' knowledge, this is the first scientific article focusing on the tongue in a systemic context. In a clinical evaluation, connections with the tongue should be considered to optimize the clinical examination of the tongue and therefore enhance rehabilitation programs and therapeutic results.

[Referral to cardiac rehabilitation of patients with left ventricular assist devices in Italy]. / Ricoveri in riabilitazione cardiologica dei pazienti sottoposti ad impianto di assistenza ventricolare sinistra in Italia.

In recent years, the lack of heart donors caused an increase in the proportion of patients undergoing left ventricular assist device (LVAD) implantation. The clinical complexity of these devices requires a multidisciplinary approach to be extended after hospital discharge. The lack of shared care pathways for these patients may result in an impairment of both of short- and long-term results. Available data show that cardiac rehabilitation (CR) improves physical performance and quality of life. Notwithstanding this, there is a lack of information about its effects on mortality, hospitalizations and major complications. This article is a survey focus on the referral to CR facilities and the number and types of LVAD implanted in Italy. Among the 24 Italian cardiac surgery centers that have been contacted, 22 provided their data: from 2012 to 2014, 260 patients underwent LVAD implantation with an in-hospital post-surgical mortality of 10%, and 77% of patients were admitted to CR facilities. For patients with LVAD, a referral to an inpatient rehabilitation unit may be considered appropriate.

Fingolimod effects on left ventricular function in multiple sclerosis.

BACKGROUND: Cardiovascular side effects such as bradycardia and atrioventricular block were observed during the early clinical trials of fingolimod in multiple sclerosis, and one cardiovascular- linked death has been reported in the post-marketing period. OBJECTIVE: To investigate the medium-term effects of fingolimod on heart function in order to obtain further insights into its cardiac safety profile. METHODS: The study involved 53 patients starting treatment with fingolimod 0.5 mg daily and 25 patients treated with natalizumab 300 mg monthly. Cardiac function was assessed by means of echocardiography at baseline (T0), and after one (T1), six (T6), and (in the case of the fingolimod group) 12 months (T12). RESULTS: Mean left ventricular ejection fraction significantly decreased and end-systolic volume increased from T0 to T1 (p=0.005) and T6 (p=0.0001) in the fingolimod but not the natalizumab group, although a slight increase was observed at T12. A similar decrease in ejection fraction was also observed after six months in nine patients switched from natalizumab to fingolimod. CONCLUSION: Fingolimod significantly reduces left ventricular systolic function in MS patients. This effect has no clinical consequences in subjects without previous cardiac disorders, but suggests that more caution is required in patients with current or previous heart failure.