Ensayos clínicos


Clinical Trial: NCT03205878 

2017/07-2019/12(expected): Telecoaching to improve physical activity in patients with obstructive sleep apnea. Patients with obstructive sleep apnea (OSA) are less physically active than healthy controls. First choice of treatment for OSA is continuous positive airway pressure (CPAP) therapy with an improvement in oxygen saturation and sleep. No improvement on physical activity has been shown. 
The current study would randomize patients in a standard care group (CPAP) and an intervention group (CPAP + telecoaching). Telecoaching will be performed for 3 months, with physical activity assessment before, after 3 months and 12 years. 

Collaborators: Universitaire Ziekenhuizen Leuven 


Clinical trial: NCT03196388 

2017/06-2018/12(expected): This research study is evaluating a drug called enzalutamide in combination with external beam radiation therapy as a possible treatment for prostate cancer. Presently, when participants receive hormonal therapy with radiation therapy for prostate cancer, medications are given to reduce testosterone levels in the blood stream. This leads to side effects such as loss of sex drive, erectile dysfunction (ED) and decrease in muscle strength. The purpose of this study is testing another form of hormonal therapy with radiation therapy. The medication called enzalutamide will be used with radiation therapy. Instead of lowering testosterone, enzalutamide blocks testosterone in cells. This study will test if enzalutamide when used with radiation will lower the PSA without causing the side effects associated with medications that lower testosterone in the blood stream. 

Collaborators: H. de Cruces (Bilbao)H. Santa Creu i Sant Pau (Barcelona), H. Vall d’Hebron (Barcelona), H. Virgen de la Arrixaca (Murcia), H. Reina Sofía (Córdoba), Complejo Hospitalario Provincial Castellón (Castellón), H. 12 de Octubre (Madrid), H. Gregorio Marañón (Madrid), H. Ramón y Cajal (Madrid), H. Universitario de G.C. Dr. Negrín (Gran Canaria)
Sponsor: Astellas Pharma Europe Ltd (UK) 


Clinical trial: NCT02643069   

2013-2018: FRAILCLINIC is aimed at assessing the feasibility and effectiveness of programs designed to detect and manage frail older patients in high risk clinical settings, and to avoid functional impairment and other associated adverse outcomes. These high-risk settings will be medical wards (cardiology, oncology/onco-haematology or nephrology), major surgery wards and Emergency Rooms. 

As a consequence, our main aim is to improve the poor outcomes of frail older people previously undetected in settings of high risk. These main poor outcomes include functional decline, institutionalization, hospitalization and death, but also under/over or mismanagement driving to avoidable secondary effects of treatment among which include denial of treatment solely on the basis of age or, by opposite, overly aggressive handling for frail patients. This pathway of care should have a relevant impact on the sustainability of health and social systems by preventing functional decline (one of the culprits of the high costs) and avoiding unnecessary interventions and their undesired secondary effects. 

Collaborators: Hospital Universitario de Getafe, Servicio Madrileño de Salud (SERMAS), Servicio de Salud Principado de Asturias, Fundación para el Fomento en Asturias de la Investigación Científica Aplicada y la Tecnología (FICYT), Diabetes Frail Limited (DIFRAIL), Cardiff University (CU)Ospedale San Raffaele S.p.A.Università Cattolica del Sacro Cuore (UCSC)
Funding: Received funding from the European Union, in the framework of the Health Programme (2008-2013).  


Clinical trial: NCT02424344 

2015-2016: The study was planned to evaluate the effect of the aclidinium bromide/formoterol fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in patients with moderate to severe COPD. Additionally, the effect of the behavioral intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg was assessed both on the exercise endurance and the physical activity. 

Sponsors: Menarini Group, Astra Zeneca 
Sites: Hamilton, Ontario, Canada; Kingston, Ontario, Canada; Sainte Foy, Quebec, Canada; Saskatoon, Saskatchewan, Canada; Berlin, Germany; Dortmund, Germany; Frankfurt, Germany; Großhansdorf, Germany; Hamburg, Germany; Hannover, Germany; Jena, Germany; Lübeck, Germany; München, Germany; Wiesbaden, Germany; Budapest, Hungary; Deszk, Hungary; Nyíregyháza, Hungary; Törökbálint, Hungary; Alicante, Spain; Cáceres, Spain; Madrid, Spain. 


Clinical trial: NCT02024776 

2013-2016: Despite recent advances, morbidity and mortality associated to major abdominal surgery is significant. A poor physical condition and functional status reduces the ability of a person to cope, mentally and physically, with hospitalization and surgery and may compromise functional recovery, potentially leading to postoperative complications and death. Prehabilitation aims to enhance functional capacity preoperatively for better toleration of surgery and to facilitate recovery and eventually the prognosis of the surgical patient. Whereas the benefits of cardiopulmonary fitness programs are well established, the accessibility, sustainability of effects, and impact on the surgical outcome of these programs are unsolved issues. Wellness programs based on integrated care services supported by Information and Communication Technology (ICT) can overcome such limitations. The investigators hypothesized that a prehabilitation program, inducing beneficial effects on exercise capacity, may improve the surgical outcome in high-risk patients. Moreover, ICT support may contribute to increase the adherence and sustainability of this intervention. 

Collaborators: Hospital Clinic of Barcelona
Sites: CogVis GmbH in collaboration with Samariterbund Wien, Medical University of Vienna and Vienna University of Technology (AUT); University of BambergInfoKom GmbH and Fraunhofer IPK (DE); TeSAN (IT); i2CAT Technological Center and Linkcare Health Services (ES) 


Clinical trial: NCT02158065  

2014-2015: A 3-month Multicenter Randomized Trial to Evaluate the Efficacy of a Physical Activity Promotion Program on the Experience of Physical Activity in Patients With COPD (MrPAPP). 

Collaborators: University of Edinburgh, Royal Brompton & Harefield NHS Foundation Trust, University Medical Center Groningen, University of Athens, University of Zurich, Centre for Research in Environmental Epidemiology, Spain 


Clinical trial: NCT01388218 

2011-2012: No current patient-centered instrument captures all dimensions of physical activity in chronic obstructive pulmonary disease (COPD). Our objective was item reduction and initial validation of two instruments to measure physical activity in COPD. 

Physical activity was assessed in a 6-week, randomized, two-way cross-over, multicenter study using PROactive draft questionnaires (daily and clinical visit versions) and two activity monitors. Item reduction followed an iterative process including classical and Rasch model analyses, and input from patients and clinical experts. 

236 COPD patients from five European centers were included. Results indicated the concept of physical activity in COPD had two domains, labeled “amount” and “difficulty”. After item reduction, the daily PROactive instrument comprised nine items and the clinical visit contained 14. Both demonstrated good model fit (person separation index >0.7). Confirmatory factor analysis supported the bi-dimensional structure. 

Both instruments had good internal consistency (Cronbach’s α>0.8), test–retest reliability (intraclass correlation coefficient ⩾0.9) and exhibited moderate-to-high correlations (r>0.6) with related constructs and very low correlations (r<0.3) with unrelated constructs, providing evidence for construct validity. 

Daily and clinical visit “PROactive physical activity in COPD” instruments are hybrid tools combining a short patient-reported outcome questionnaire and two activity monitor variables which provide simple, valid and reliable measures of physical activity in COPD patients. 

Collaborators: Katholieke Universiteit LeuvenUniversity of EdinburghRoyal Brompton & Harefield NHS Foundation TrustUniversity Medical Center GroningenUniversity of AthensCentre for Research in Environmental Epidemiology, Spain 

Urban training 

Clinical trial: NCT01897298 

This project plans on a training intervention by using public spaces and urban walkable trails, adapted to each patient needs and capabilities. Primary objective is to assess 12 months effectiveness of the intervention with respect to: (primary outcome): physical activity level, and (secondary outcomes): COPD admissions, exercise capacity, body composition, quality of life, and mental health. 

Funding: Fondo de Investigación Sanitaria, Ministry of Health, Spain (FIS PI11/01283) 
Collaborators: Instituto de Salud Carlos III, Fondo de Investigación Sanitaria, Madrid; Sociedad Española de Neumología (SEPAR), BarcelonaUniversity Ramon Llull; Hospital Clinic of Barcelona; Hospital del MarGermans Trias i Pujol Hospital: IDIAP Jordi Gol, Barcelona; Hospital de Mataró, Mataró; Hospital de Viladecans, ViladecansUniversitat Internacional de Catalunya; Centre for Research in Environmental Epidemiology, Spain


Clinical trial: NCT02618746  

2013-2014: COPD is the fourth leading cause of death in the world and is the only one of the top five illnesses whose death rate is still increasing. The disease is mainly caused by smoking in western countries. Greece has a higher prevalence and death rate for COPD than many other countries in Europe. The disease is incurable, so treatment is aimed at alleviating symptoms and slowing progression. Despite maximal medication and strategies such as pulmonary rehabilitation and home nurse support, many patients remain vulnerable, socially isolated and report difficulty in accessing their local health services. Research has shown that patients have worsening symptoms for an average of three to four days before they are admitted to hospital with an exacerbation of COPD. This suggests a window of opportunity to intervene. Early warning and contact via innovative technology may treat symptoms earlier, improve patient confidence / quality of life and simultaneously reduce health care visits or admissions. However, there is a large gap between the postulated and empirically demonstrated benefits of electronic Health Technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated, despite being frequently promoted by policymakers as if this was a given issue. In addition, the evidence-base for tele-health is not well-reported in peer reviewed journals and hence there continue to be difficulties experienced in convincing clinicians, hospital managers and stakeholders that investment in such technologies will enable reductions in other aspects of healthcare delivery over time. 

TELECARE attempts to provide robust justification of the effectiveness of tele-rehabilitation by the implementation of a randomized controlled trial blindly assigning COPD patients to: i) a home care and tele-rehabilitation group remotely monitored by a specialized private health care center (Filoktitis – group A) or ii) a hospital-based rehabilitation group managed at a regular base through weekly visits by personnel at a state University rehabilitation center (group B). iii) A third group that receives usual care (group C: control group; i.e.: neither home monitoring nor hospital-based rehabilitation) is also included.