FAQ

In a nutshell, what is the overall goal of the project? 

The SPRINTT project is focused at providing all the necessary information and tools for identifying and treating a specific subpopulation of older persons at risk of mobility disability (loss of independence) showing precise clinical, biological, and functional characteristics. In particular, SPRINTT is specifically aimed at providing a clear, objective, scientifically-based and clinically-relevant operational definition of Physical Frailty & Sarcopenia (PF&S). A major resource of SPRINTT will be the conduction of a large-scale randomized clinical trial aimed at testing the effectiveness of a multicomponent intervention (based on physical activity, nutritional counselling, and innovative technologies) vs. a health educational program in preventing mobility disability in community-dwelling older persons with PF&S. This clinical trial will provide information on the prevalence of PF&S among European older adults and will test a novel strategy to prevent disability in this vulnerable population.

Once disability has emerged, the restoration of an adequate level of functioning is very unlikely, especially when the age of the subject, the degree of disability or its duration increase. It is therefore necessary to anticipate the onset of disabling conditions by targeting community-dwelling older persons that are not yet disabled, but already show preliminary signs/symptoms. In this context, the geriatric conditions of frailty (i.e., a multidimensional syndrome characterized by decreased reserve and diminished resistance to stressors) and sarcopenia (i.e., the progressive and generalized loss of skeletal muscle mass and strength) are of special interest as targets for interventions against disability and major negative health-related outcomes.

Unfortunately, to date, no healthcare programs or pharmacological treatments are available for frail elders. This is largely due to the current lack of a precise, universal definition of frailty, which in turn is linked to the multidimensional nature of the condition. The identification of a definite biological basis (i.e. skeletal muscle decline) opens new venues for the development of interventions to slow or reverse the progression of the PF&S condition (especially towards disabling conditions).

According to the Survey of Health, Aging and Retirement in Europe (SHARE) study, the prevalence of pre-frailty and frailty among community-dwelling older persons is 42.3% and 17.0%, respectively. In the absence of targeted interventions, the progression of frailty is marked by increased morbidity, disability, frequent and often inappropriate healthcare use, nursing home admission, and poor quality of life. This implies that disabling conditions are not only extremely burdening for the individual, but represent a major threat for the sustainability of health care system. Detecting and contrasting PF&S are therefore of outstanding importance for impeding the progression of the risk condition and preventing its detrimental consequences.

To date, no healthcare programs or pharmacological treatments are available for frail older people. This is largely due to the current lack of a precise, universal definition of frailty, which in turn is linked to the multidimensional nature of the condition. Moreover, the existing gaps in knowledge are reflected by the absence of effective interventions (either pharmacological or behavioral) against frailty. Such a barrier may be overcome by developing and validating a robust conceptual framework of frailty to achieve a practical operationalization of the condition. This conceptualization should also improve the definition of the pathophysiological and clinical foundations of frailty to assist in the design and implementation of specific therapeutic interventions aimed at restoring robustness or delaying the onset of adverse events (in particular, disability).

The SPRINTT project is geared to produce significant advancements in the management of frail elders by promoting a consensus among academia, regulators, industry, and patients’ representatives over

(1) clear operationalization of the presently vague concept of frailty;

(2) identification of a precise target population with unmet medical needs;

(3) evaluation and validation of a new methodology for implementing in Europe preventive and therapeutic strategies among frail elders at risk of disability;

(4) definition of an experimental setting serving as template for regulatory purposes and pharmaceutical investigations;

(5) identification of biomarkers and m-health technology solutions to be implemented into clinical practice.

A major output of the project will be the definition of a conceptual framework of PF&S, the implementation of which will identify a specific "nosographical entity" for healthcare professionals, research activities, pharmaceutical industry, regulators, and policy-makers.

The SPRINTT results will thus have relevant clinical and public health implications, filling an important gap in knowledge for practicing evidence-based geriatric medicine. The ultimate goals of SPRINTT are to offer efficient treatment options to physically frail, sarcopenic older persons and to increase their quality of life.

This will directly support the long-term sustainability and efficiency of health- and social-care systems.

A major output of the project will be the definition of a conceptual framework of PF&S, the implementation of which will identify a specific "nosographical entity" for healthcare professionals, research activities, pharmaceutical industry, regulators, and policy-makers.

The SPRINTT results will thus have relevant clinical and public health implications, filling an important gap in knowledge for practicing evidence-based geriatric medicine. The ultimate goals of SPRINTT are to offer efficient treatment options to physically frail, sarcopenic older persons and to increase their quality of life. This will directly support the long-term sustainability and efficiency of health- and social-care systems.

 

In order to develop an agreed, scientifically robust, and clinically relevant condition of risk as the proposed PF&S, it is necessary that all the major stakeholders involved in the prevention and care of the older persons (e.g., academia, pharmaceutical industries, experts in bioethics, public health economists, patients' representatives) might provide their expertise and recommendations. Only through a close collaboration between public and private partners will allow the production of results that are not only scientifically robust, but also pave the way for the future clinical implementation (in everyday medical practice) and the development of innovative pharmacological/biological treatments.

 

Results generated by SPRINTT will provide the necessary evidence to indisputably identify a segment of the elderly population at risk for adverse outcomes whose medical needs are presently unmet, partly due to the vagueness of the current definition of frailty. The identification of a definite biological basis underlying frailty (i.e. skeletal muscle decline) opens new venues for research and development of interventions specifically aimed at slowing or reversing the progression of the PF&S condition of interest (especially towards disabling conditions). Regulatory appraisal of the clinical trial results (data generated during the project) will foster the development of innovative medicines for the condition of PF&S, by providing a reference framework and shared methodologies.

The consortium is composed by internationally recognized experts in the field of frailty and sarcopenia. The multidimensionality of PF&S required the creation of a consortium characterized by multiple expertise and backgrounds. Therefore, in SPRINTT, the following key areas of expertise can be found:

  • Geriatrics
  • Gerontology
  • Health Technology Assessment
  • Bioethics
  • Biomarkers of aging
  • Muscle physiology
  • Nutrition
  • Statistics
  • Novel clinical trial methodologies (especially applied to clinical trials in the elderly)
  • Preventive medicine
  • Information and Communication Technology, including m-health
  • Physical exercise (especially adapted to older persons)
  • Regulatory science
  • Comprehensive geriatric assessment
  • Aging
  • Physical function
  • Physical disability
  • Mobility

The conceptualization of PF&S as proposed in SPRINTT will promote significant advancements over the traditional approaches by enabling the precise operationalization of the condition, a clear identification of the affected population and the rapid translation of findings to the clinical arena.

The intervention proposed in the SPRINT-T trial is original (although founded on solid background and data, a multicomponent intervention against the outcome of mobility disability has never been tested on a large scale), relevant (it targets conditions of high prevalence in European community-dwelling elders), pertinent (it is focused on function, that is a primary component of quality of life and the most important outcome in the elderly), easily applicable at a population level (thus facilitating the future clinical implementation of its findings), and scalable (it will validate health technology services and ICT infrastructures for optimal data acquisition/analysis, clinical decision-making, and accessibility to the interventions from the participant’s home).

The randomized controlled trial to be conducted within the SPRINTT project activities will represent the largest study conducted in Europe for determining whether disability might be prevented by targeting specific risk factors (i.e., the PF&S condition). At the same time, the trial will indirectly provide the opportunity to identify older persons with PF&S which may not be responsive to healthy lifestyle modifications, thus identifying individuals who may require additional treatment to prevent/reverse the disabling process. Generated data will allow secondary clinical research and provide a solid basis for scientific and regulatory consensus beyond Europe, by the mean of metanalyses with parallel research programs implemented in other world regions.

The SPRINTT consortium is composed by partners from more than 20 private and public institutions distributed over 11 European countries.