The efficacy of heart rate variability biofeedback training on sleep disorders and impact of fibromyalgia: Results of a phase II randomized controlled trial.

OBJECTIVE: Fibromyalgia syndrome (FMs) is a chronic, musculoskeletal pain disorder characterized by sleep disturbances, fatigue, and cognitive dysfunction. Heart rate variability biofeedback (HRV-BF) aiming to improve self-regulation and strengthen the parasympathetic nervous system has been shown to be effective in several pain syndromes, but its efficacy in FMs has not been adequately investigated. This Phase II trial aimed to assess the feasibility and preliminary measurement of the improvement induced by HRV-BF in FMs. METHODS: Sixty-four patients with FMs were recruited. Patients were randomly assigned to either the experimental group (EG) or the control group (CG). The EG received 10 HRV-BF training sessions in addition to pharmacological standard therapy. The CG received standard therapies for 10 weeks. The FMs impact on daily life, sleep regularity, sense of coherence, depression symptoms and pain has been assessed as primary outcomes, quality of life as secondary. RESULT: 23 (71.9%) of EG patients completed the intervention and 20 (62.5%) of the CG were re-evaluated at time T1. No side effects were reported. It was not found any statistical differences between groups over time in primary and secondary outcomes. CONCLUSIONS: The HRV-BF intervention did not demonstrate efficacy in both primary and secondary outcomes. However, it is quite feasible in terms of drop-out rate and side effects. Further studies with larger sample sizes are needed to determine its actual efficacy. CLINICALTRIALS: gov with code: NCT04121832.

Anti-CGRP and Anti-CGRP Receptor Monoclonal Antibodies for Migraine Prophylaxis: Retrospective Observational Study on 209 Patients.

BACKGROUND: Migraine is a neurological disorder characterized by attacks of head pain with prevalent unilateral localization, moderate to high intensity and specifically associated accompanying symptoms. METHODS: In this retrospective observational study, we analyzed data regarding 209 patients who had previously been diagnosed with migraine and who were prescribed, between 2019 and 2022, subcutaneous injections of anti-CGRP monoclonal antibodies (mAbs) fremanezumab or galcanezumab or anti-CGRP receptors mAb erenumab regardless of the concomitant assumption of any other acute-phase or prophylactic migraine medication. RESULTS: Regarding efficacy, in the 205 analyzed patients, the change from baseline in terms of MIDAS, HIT-6, MMDs and MAD scores was statistically significant for erenumab and galcanezumab, while for fremanezumab a statistical significance was not achieved likely due to the small sample size. In the treated population, 36 patients (17.5%) reported AEs (pain during injection, transient injection site erythema, nausea, constipation and fatigue). Only 5 patients (2.4%) discontinued the treatment for AEs while 15 patients (7.3%) left for lack of efficacy. CONCLUSIONS: this retrospective study comes out in favor of both significant efficacy and safety of anti-CGRP and anti-CGRP receptors mAbs in migraine patients. Further methodologically stronger studies are necessary to validate our observation.

Safety and efficacy of ketorolac continuous infusion for multimodal analgesia of vaso-occlusive crisis in patients with sickle cell disease.

Pain is an hallmark of sickle-cell-related acute clinical manifestations as part of acute vaso-occlusive crisis (VOC). In SCD pain has different origins such as vascular or neuropathic pain, which requires multimodal analgesia. This is based on the administration of drugs with different pharmacological mechanisms of action, maximizing analgesia and minimizing their adverse events and the risk of drug-addition in patients experiencing acute-recurrent pain events as in SCD. Ketorolac is a potent non-narcotic analgesic, being relatively safe and effective during pain-management in children and adults. Up to now, there is a lack of safety information on continuous infusion ketorolac as used to control acute pain in patients with SCD, and the benefits/risks ratio needs to be investigated. Here, we report for the first time the safety profile of ketorolac in the special population of patients with SCD. We confirmed that ketorolac in combination with tramadol, an opioid like molecule, is effective in pain control of adult patients with SCD experiencing acute severe VOCs defined by pain visual analog scale. Our study shows that short term (72 h) continuous infusion of ketorolac plus tramadol is not associated with adverse events such as liver or kidney acute disfunction or abnormalities in coagulation parameters during patients' hospitalization and within 30 days after patients discharge. This is extremely important for patients with SCD, who should have access to multimodal therapy to control recurrent acute pain crisis in order to limit central sensitization a fearsome issue of undertreated recurrent acute pain and of chronic pain.

Exploring Outcome Priorities and Real-Life Management of Chemotherapy-Induced Peripheral Neurotoxicity: A Survey of the Italian Association for the Study of Pain members.

Introduction: Chemotherapy-induced peripheral neurotoxicity (CIPN) affects nearly 70% of cancer patients after chemotherapy, causing sensory, motor, autonomic dysfunction, and neuropathic pain. The Desirability of Outcome Ranking (DOOR) framework is proposed as a better way to assess preventive or therapeutic interventions for CIPN. Methods: A survey was conducted among Italian healthcare professionals and researchers affiliated to the Italian Chapter of the International Association for the Study of Pain (AISD) to identify the most important outcomes in clinical management and research. Results: Among the 73 respondents, 61 qualified for the survey, with an overall response rate of 1.2%. The vast majority were physicians (77%), most of whom were anesthesiologists (47.5%). The results showed that pain, survival, sensory impairment, motor impairment, and quality of life were consistently ranked as the most important outcomes, but there was significant disagreement in the outcomes relative ranking, making it difficult to develop a DOOR algorithm. The study also revealed that clinicians commonly use structured interviews to evaluate patients with CIPN, and the most prescribed drugs or supplements were palmitoylethanolamide, pregabalin, gabapentin and alpha lipoic acid as preventive agents and pregabalin, palmitoylethanolamide, duloxetine, gabapentin, and amitriptyline as therapeutic agents. However, many of these drugs have not been clinically proven to be effective for CIPN. Discussion: This study suggests that the implementation of a DOOR framework for CIPN using healthcare professionals is more difficult than expected, given the significant disagreement in our respondents' ranking of outcomes. Our work provides interesting topics for future research in CIPN, but its limitations include a small sample size, a low response rate, and a possible selection bias.

Pulmonary Vasodilator and Inodilator Drugs in Cardiac Surgery: A Systematic Review With Bayesian Network Meta-Analysis.

OBJECTIVE: The authors performed a systematic review to evaluate the effect of pharmacologic therapy on pulmonary hypertension in the perioperative setting of elective cardiac surgery (PROSPERO CRD42023321041). DESIGN: Systematic review of randomized controlled trials with a Bayesian network meta-analysis. SETTING: The authors searched biomedical databases for randomized controlled trials on the perioperative use of inodilators and pulmonary vasodilators in adult cardiac surgery, with in-hospital mortality as the primary outcome and duration of ventilation, length of stay in the intensive care unit, stage 3 acute kidney injury, cardiogenic shock requiring mechanical support, and change in mean pulmonary artery pressure as secondary outcomes. PARTICIPANTS: Twenty-eight studies randomizing 1,879 patients were included. INTERVENTIONS: Catecholamines and noncatecholamine inodilators, arterial pulmonary vasodilators, vasodilators, or their combination were considered eligible interventions compared with placebo or standard care. MEASUREMENTS AND MAIN RESULTS: Ten studies reported in-hospital mortality and assigned 855 patients to 12 interventions. Only inhaled prostacyclin use was supported by a statistically discernible improvement in mortality, with a number-needed-to-treat estimate of at least 3.3, but a wide credible interval (relative risk 1.26 × 10-17 - 0.7). Inhaled prostacyclin and nitric oxide were associated with a reduction in intensive care unit stay, and none of the included interventions reached a statistically evident difference compared to usual care or placebo in the other secondary clinical outcomes. CONCLUSIONS: Inhaled prostacyclin was the only pharmacologic intervention whose use is supported by a statistically discernible improvement in mortality in the perioperative cardiac surgery setting as treatment of pulmonary hypertension. However, available evidence has significant limitations, mainly the low number of events and imprecision.

High dose esomeprazole as an anti-inflammatory agent in sepsis: Protocol for a randomized controlled trial.

BACKGROUND: Sepsis is caused by dysregulated immune responses due to infection and still presents high mortality rate and limited efficacious therapies, apart from antibiotics. Recent evidence suggests that very high dose proton pump inhibitors might regulate major sepsis mediators' secretion by monocytes, which might attenuate excessive host reactions and improve clinical outcomes. This effect is obtained with doses which are approximately 50 times higher than prophylactic esomeprazole single daily administration and 17 times higher than the cumulative dose of a three day prophylaxis. We aim to perform a randomized trial to investigate if high dose esomeprazole reduces organ dysfunction in patients with sepsis or septic shock. METHODS: This study, called PPI-SEPSIS, is a multicenter, randomized, double blind, placebo-controlled clinical trial on critically ill septic patients admitted to the emergency department or intensive care unit. A total of 300 patients will be randomized to receive high dose esomeprazole (80 mg bolus followed by 12 mg/h for 72 h and a second 80 mg bolus 12 h after the first one) or equivolume placebo (sodium chloride 0.9%), with 1:1 allocation. The primary endpoint of the study will be mean daily Sequential Organ Failure Assessment (SOFA) score over 10 days. Secondary outcomes will include antibiotic-free days, single organ failure severity, intensive care unit-free days at day 28, and mortality. DISCUSSION: This trial aims to test the efficacy of high dose esomeprazole to reduce acute organ dysfunction in patients with septic shock. TRIAL REGISTRATION: This trial was registered on ClinicalTrials.gov with the trial identification NCT03452865 in March 2018.

The Effect of Heparin Full-Dose Anticoagulation on Survival of Hospitalized, Non-critically Ill COVID-19 Patients: A Meta-analysis of High Quality Studies.

BACKGROUND: International COVID-19 guidelines recommend thromboprophylaxis for non-critically ill inpatients to prevent thrombotic complications. It is still debated whether full-dose thromboprophylaxis reduces all-cause mortality. The main aim of this updated systematic review and meta-analysis is to evaluate the effect of full-dose heparin-based thromboprophylaxis on survival in hospitalized non-critically ill COVID-19 patients. METHODS: A systematic review was performed across Pubmed/Medline, EMBASE, Cochrane Central Register of clinical trials, Clinicaltrials.gov, and medRxiv.org from inception to November 2022. We conducted a meta-analysis of randomized clinical trials (RCTs) comparing full-dose heparin-based anticoagulation to prophylactic or intermediate dose anticoagulation or standard treatment in hospitalized non-critically ill COVID-19 patients. The risk of bias was assessed using the Cochrane risk-of-bias tool for randomized trials and Grading of Recommendations Assessment, Development and Evaluation was applied. The primary outcome was all-cause mortality at the longest follow-up available. RESULTS: We identified 6 multicenter RCTs involving 3297 patients from 13 countries across 4 continents. The rate of all-cause mortality was 6.2% (103/1662) in the full-dose group vs 7.7% (126/1635) in the prophylactic or intermediate dose group (Risk Ratio [RR] = 0.76; 95% confidence interval [CI] = 0.59-0.98; P = 0.037). The probabilities of any mortality difference and of NNT ≤ 100 were estimated at 98.2% and 84.5%, respectively. The risk of bias was low for all included RCTs and the strength of the evidence was "moderate." CONCLUSION: Our meta-analysis of high-quality multicenter RCTs suggests that full-dose anticoagulation with heparin or low molecular weight heparin reduces all-cause mortality in hospitalized non-critically ill COVID-19 patients. STUDY REGISTRATION: PROSPERO, review no. CRD42022348993.

The Great pretender: the first case of septic shock due to Capnocytophaga canimorsus in Sardinia. A Case report and review of the literature.

Capnocytophaga canimorsus (C. canimorsus) is an emerging pathogen in critical care. C. canimorsus is a Gram-negative bacillus, commonly isolated as a commensal microorganism of the oral flora of healthy dogs and cats. A 63-year-old woman came to the emergency department with fever, chills, and malaise 2 days after a minor dog bite. After admission to the medicine ward, she developed respiratory failure and livedo reticularis. In the intensive care unit (ICU), she presented full-blown septic shock with thrombocytopenia, coagulopathy, severe acute kidney injury, and liver injury. We describe the first case of septic shock with Multiple Organ Dysfunction Syndrome related to Capnocytophaga canimorsus infection in Sardinia and its treatment in a tertiary hospital ICU. We also review recent literature on the relevance of C. canimorsus in human disease and critical illness.

Efficacy and safety of heparin full-dose anticoagulation in hospitalized non-critically ill COVID-19 patients: a meta-analysis of multicenter randomized controlled trials.

Arterial and venous thrombotic events in COVID-19 cause significant morbidity and mortality among patients. Although international guidelines agree on the need for anticoagulation, it is unclear whether full-dose heparin anticoagulation confers additional benefits over prophylactic-dose anticoagulation. This systematic review and meta-analysis aimed to investigate the efficacy and safety of heparin full-dose anticoagulation in hospitalized non-critically ill COVID-19 patients. We searched Pubmed/Medline, EMBASE, Clinicaltrials.gov, medRxiv.org and Cochrane Central Register of clinical trials dated up to April 2022. Randomized controlled trials (RCTs) comparing full-dose heparin anticoagulation to prophylactic-dose anticoagulation or standard treatment in hospitalized non-critically ill COVID-19 patients were included in our pooled analysis. The primary endpoint was the rate of major thrombotic events and the co-primary endpoint was the rate of major bleeding events. We identified 4 studies, all of them multicenter, randomizing 2926 patients. Major thrombotic events were 23/1524 (1.5%) in full-dose heparin anticoagulation versus 57/1402 (4.0%) in prophylactic-dose [relative risk (RR) 0.39; 95% confidence interval (CI) 0.25-0.62; p˂0.01; I2 = 0%]. Clinical relevant bleeding events occurred in 1.7% (26/1524) among patients treated with heparin full anticoagulation dose compared to 1.1% (15/1403) in prophylactic-dose group (RR 1.60; 95% CI 0.85-3.03; p = 0.15; I2 = 20%). Mortality was 6.6% (101/1524) versus 8.6% (121/1402) (RR 0.63; 95% CI 0.33-1.19; p = 0.15). In this meta-analysis of high quality multicenter randomized trials, full-dose anticoagulation with heparin was associated with lower rate of major thrombotic events without differences in bleeding risk and mortality in hospitalized non critically ill COVID-19 patients.Study registration PROSPERO, review no. CRD42022301874.

COVID-19 Pandemic Impact on Undergraduate Nursing Students: A Cross-Sectional Study.

COVID-19 is a challenge for education systems around the world. This study aimed to evaluate the perceived impact of the COVID-19 pandemic on nursing students, by assessing their emotions, the level of concern in contracting the virus and their perceived stress. We conducted an observational cross-sectional study. A total of 709 nursing students completed an anonymous questionnaire. The levels of anxiety and stress were assessed using the generalized anxiety disorder scale and the COVID-19 student stress questionnaire, respectively. In total, 56.8% of the sample often or always found it difficult to attend distance-learning activities. The main difficulty referred to was connection problems (75.7%). The mean generalized anxiety disorder score was 9.46 (SD = 5.4) and appeared almost homogeneous among students across the three years of study; most of the students showed mild (35%) to moderate (27%) levels of anxiety; 19% had severe anxiety. The overall COVID-19 stressor mean scores were 11.40 (SD = 6.50); the majority of the students (47.1%) showed scores indicative of moderate stress, 25% showed low stress levels, and 28% showed high-stress levels. Improvements and investments are needed to ensure high-quality distance learning, adequate connectivity, technical support for students, as well as strategies to promote mental health.

Persistent Idiopathic Facial Pain (PIFP) in Patients Referred to a Multidisciplinary Centre in Italy: A Retrospective Observational Study.

BACKGROUND: Persistent Idiopathic Facial Pain (PIFP), previously named Atypical Facial Pain (AFP) is a poorly understood condition, often diagnosed after several inconclusive investigations. The aim of this retrospective study was to evaluate the demographic and clinical characteristics of patients with PIFP referred to a Facial Pain Center. METHODS: Between May 2011 and September 2014, data on 41 PIFP patients were analyzed regarding temporal, topographical and descriptive pain features, including onset, localization, pain descriptors and intensity. Pharmacological pain treatments were also registered. Finally, the presence and type of previous minor oro-surgery procedures in the painful area were investigated. RESULTS: Demographic and clinical characterization were similar to PIFP patients reported in literature. The presence of previous minor oro-surgery procedures in the painful area was reported in most of these patients, in particular endodontic treatments and tooth extractions. CONCLUSIONS: This retrospective analysis showed a high prevalence of minor oro-surgery procedures in our population, while its role in PIFP pathophysiology remains unknown. A new classification of PIFP built around the main discriminant factor of presence of these procedures in the painful area could be considered while available data were still insufficient to define specific diagnostic criteria.

Experiences, Emotions, and Health Consequences among COVID-19 Survivors after Intensive Care Unit Hospitalization.

Literature suggested that COVID-19 patients experienced hospitalization as a physically and psychologically stressful event, with the risk to develop post-traumatic stress symptoms. The study aimed to understand psychological experiences of COVID-19 survivors with severe complications during and after ICU hospitalization, and any relevant health consequences. From October 2020 to January 2021, a qualitative study was conducted in Italy via semi-structured interviews by phone or video call addressed to COVID-19 survivors, randomly enrolled among people who released their stories publicly on newspapers, television, or social media. Fifteen individuals (three women and twelve men with average age of 56.4 years) were interviewed. Four main themes emerged: (i) emotion of fear; (ii) isolation and loneliness; (iii) unawareness about the gravity of the situation as a protective factor; (iv) "Long COVID" as consequences of the disease on physical and psychological health. During hospitalization, 66.7% of participants had mild or moderate values of anxiety and depression. After discharge, 86.7% moved to normal values. The results suggest that long-COVID is an important problem to manage to improve patients' quality of life. It is essential to guarantee a holistic take in charge starting before the discharge and continuing care after discharge in the community where they live.

Metabolomics and Microbiomics: New Potential Strategies in Chronic Pain Syndrome.

Chronic pain affects almost 20% of the European adult population and it significantly reduces patients' quality of life. Chronic pain is considered a multidimensional experience determined by the interaction of several genetic and environmental factors. The effect of specific genetic contributions is often unclear, and the interpretation of the results from studies focused on genetic influences on pain has been complicated by the existence of multiple pain phenotypes. A step forward from genetics could be given by the application of metabolomics and microbiomics tools. Metabolomics is a powerful approach for hypothesis generation in biology, and it aims to analyze low molecular weight compounds, either metabolic intermediates or metabolic end-products, resulting from human or microbial metabolism. Microbiomics is a fast-growing field in which all the microbes are examined together, and as a result, its perturbation may indicate the development of chronic diseases. By applying these methodologies for the study of chronic pain, several differences have been identified. The alteration of the choline-PAF pathway is an intriguing finding recognized by several groups. In our opinion, metabolomics and microbiomics techniques will allow significant progress into the medical field. Patients may benefit from the possibility of being stratified and classified based on their metabolic and microbial profile, which, in the next future, may lead to personalized therapy.

Raising Awareness on the Clinical and Social Relevance of Adequate Chronic Pain Care.

Appropriate pain care should be regarded as a right and effectively guaranteed to people with chronic pain (CP). Law 38, enacted in Italy in 2010, establishes the citizen's right not to suffer. Twelve years later, such right appears still disregarded in Italy and the current access to adequate pain care reveals significant shortcomings. In addition, a mismatch between CP-associated burden and the available healthcare resources in the framework of our national health system has been observed. This article gathers the perspectives of a Board of Italian anesthesiologists on the state of the art of CP management in Italy and aims at strengthening the scientific rationale and clinical relevance of pursuing the enforceability of the right not to suffer and at promoting widespread multidisciplinary care of patients with CP.

Moderate Exercise Improves Cognitive Function in Healthy Elderly People: Results of a Randomized Controlled Trial.

BACKGROUND: Physical activity in the elderly is recommended by international guidelines to protect against cognitive decline and functional impairment. OBJECTIVE: This Randomized Controlled Trial (RCT) was set up to verify whether medium-intensity physical activity in elderly people living in the community is effective in improving cognitive performance. DESIGN: RCT with parallel and balanced large groups. SETTING: Academic university hospital and Olympic gyms. SUBJECTS: People aged 65 years old and older of both genders living at home holding a medical certificate for suitability in non-competitive physical activity. METHODS: Participants were randomized to a 12-week, 3 sessions per week moderate physical activity program or to a control condition focused on cultural and recreational activities in groups of the same size and timing as the active intervention group. The active phase integrated a mixture of aerobic and anaerobic exercises, including drills of "life movements", strength and balance. The primary outcome was: any change in Addenbrooke's Cognitive Examination Revised (ACE-R) and its subscales. RESULTS: At the end of the trial, 52 people completed the active intervention, and 53 people completed the control condition. People in the active intervention improved on the ACE-R (ANOVA: F(1;102)=4.32, p=0.040), and also showed better performances on the memory (F(1;102)=5.40 p=0.022) and visual-space skills subscales of the ACE-R (F(1;102)=4.09 p=0.046). CONCLUSION: A moderate-intensity exercise administered for a relatively short period of 12 weeks is capable of improving cognitive performance in a sample of elderly people who live independently in their homes.Clinical Trials Registration No: NCT03858114.

Clinical practice recommendations on the management of perioperative cardiac arrest: A report from the PERIOPCA Consortium.

BACKGROUND: Perioperative cardiac arrest is a rare complication with an incidence of around 1 in 1400 cases, but it carries a high burden of mortality reaching up to 70% at 30 days. Despite its specificities, guidelines for treatment of perioperative cardiac arrest are lacking. Gathering the available literature may improve quality of care and outcome of patients. METHODS: The PERIOPCA Task Force identified major clinical questions about the management of perioperative cardiac arrest and framed them into the therapy population [P], intervention [I], comparator [C], and outcome [O] (PICO) format. Systematic searches of PubMed, Embase, and the Cochrane Library for articles published until September 2020 were performed. Consensus-based treatment recommendations were created using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system. The strength of consensus among the Task Force members about the recommendations was assessed through a modified Delphi consensus process. RESULTS: Twenty-two PICO questions were addressed, and the recommendations were validated in two Delphi rounds. A summary of evidence for each outcome is reported and accompanied by an overall assessment of the evidence to guide healthcare providers. CONCLUSIONS: The main limitations of our work lie in the scarcity of good quality evidence on this topic. Still, these recommendations provide a basis for decision making, as well as a guide for future research on perioperative cardiac arrest.

Worries, Preparedness, and Perceived Impact of Covid-19 Pandemic on Nurses' Mental Health.

Background: In times of global public health emergency, such as the COVID-19 pandemic, nurses stand at the front line, working in close contact with infected individuals. Being actively engaged in fighting against COVID-19 exposes nurses to a high risk of being infected but can also have a serious impact on their mental health, as they are faced with excessive workload and emotional burden in many front-line operating contexts. Purpose: The aim of the study is to analyze how risk factors such as perceived impact, preparedness to the pandemic, and worries were associated with mental health outcomes (crying, rumination and stress) in nurses. Methods: A cross-sectional study design was performed via an online questionnaire survey. Participants included 894 registered nurses from Italy. Participation was voluntary and anonymous. Multiple binary logistic regression was carried out to analyze the relationship between risk factors and health outcomes. Results: Increased job stress was related to higher levels of rumination about the pandemic (OR = 4.04, p < 0.001), job demand (OR = 2.00, p < 0.001), impact on job role (OR = 2.56, p < 0.001), watching coworkers crying at work (OR = 1.50, p < 0.05), non-work-related concerns (OR = 2.28, p < 0.001), and fear of getting infected (OR = 2.05, p < 0.001). Job stress (OR = 2.52, p < 0.01), rumination (OR = 2.28, p < 0.001), and watching colleagues crying (OR = 7.92, p < 0.001) were associated with crying at work. Rumination was associated with caring for patients who died of COVID-19 (OR = 1.54, p < 0.05), job demand (OR = 1.70, p < 0.01), watching colleagues crying (OR = 1.81, p < 0.001), non-work-related worries (OR = 1.57, p < 0.05), and fear of getting infected (OR = 2.02, p < 0.001). Conclusions: The psychological impact that this pandemic may cause in the medium/long term could be greater than the economical one. This is the main challenge that health organizations will have to face in the future. This study highlights that the perceived impact and worries about the pandemic affect nurses' mental health and can impact on their overall effectiveness during the pandemic. Measures to enhance nurses' protection and to lessen the risk of depressive symptoms and post-traumatic stress should be planned promptly.

Active elderly and health-can moderate exercise improve health and wellbeing in older adults? Protocol for a randomized controlled trial.

BACKGROUND: Aging is marked by a progressive rise in chronic diseases with an impact on social and healthcare costs. Physical activity (PA) may soothe the inconveniences related to chronic diseases, has positive effects on the quality of life and biological rhythms, and can prevent the decline in motor functions and the consequent falls, which are associated with early death and disability in older adults. METHODS: We randomized 120 over-65 males and females into groups of similar size and timing and will give each either moderate physical activity or cultural and recreational activities. Being younger than 65 years, inability to participate in physical activity for any medical reason, and involvement in a massive program of physical exercise are the exclusion criteria. The primary outcome measures are: quality of life, walking speed, and postural sway. Participants are tested at baseline, post-treatment, and 6-month (24 weeks) and 12-month (48 weeks) follow-ups. DISCUSSION: This study aims at improving the quality of life, wellness, and cognitive functioning in the elderly through a low-cost affordable program of moderate physical activity. Given the growing aging of the world population and the social and economic burden of disability in the elderly, our results might have a major impact on future practices. TRIAL REGISTRATION: ClinicalTrials.gov NCT03858114 . Registered on 28 February 2019.