MID-Frail – WORKPACKAGES
The aim of WP1 is to ensure the proper functioning of the project so that the predefined objectives are met within the proposed timeframe. This WP also deals with the requirements concerning the scientific management of the project.
The aim of WP2 is to ensure that the study is internally valid and that any sources of variability, bias or error within each phase of the project are minimised. Several partners are involved in coordinating this activity and additional input from local experts (within each country) will be commissioned to ensure adherence to the requirements of the protocol.
The aim of WP3 is to implement, manage and monitor the randomised controlled trial.
The aim of WP4 is to define which of the many components of a multimodal intervention will be implemented in this project.
The aim of WP5 is to ensure an adequate management and analysis of the data collected so that data recording is timely, complete and accurate. Both the Statistical and the Health Economic Analysis plans will be finalised before any data is collected. Interim (blinded) reports will be prepared and the final analysis will be done immediately after freezing the database. Final Statistical and Health Economic Analysis Report will be completed.
The aim of WP6 is to identify which factors are involved in the development of frailty in people with type 2 diabetes, to assess the effectiveness of the physical intervention and how it impacts on quality of life, and to determine the predictive value of response to treatment for each of the factors identified. The mechanisms underlying the effectiveness of the intervention, if any, will also be clarified.
The aim of WP7 is to achieve maximum exploitation and dissemination of the results obtained in this project. The ways and means by which the project results are to be exploited will be identified. The wide diffusion of the project results from both a scientific and an industrial point of view will be achieved via dissemination processes.
The aim of this WP8 is to provide resources for effective coordination of all project-related activities and maintenance of contact with Commission representatives.
To capitalise on the long duration of the study and the large number of subjects involved, several sub-studies will be carried out:
- Sartrain Sub-Study: will investigate by sono-elastography the characteristics of skeletal muscle and adjacent tissues at the beginning and at the end of the intervention
- MID-POW Sub-study: will assess the exercise-induced, short- and long-term changes in muscle power output, balance and gait as mediators of the final response on function
- Sensole Sub-study: will analyse the kinetic and kinematic movement data
- MetaboFrail Sub-study: will characterise the metabolic profile of frail/sarcopenic elderly subjects with diabetes and will outline the changes in these parameters following the intervention
- GeneFrail Sub-study: will determine the polymorphisms of three genes (Pro259Arg-TCN2 gene; ACE I/D-ACE gene and e2/e3/e4-Apo E gene) to establish their predictive value for the development of disability and response to treatment
- QoL-Frail Sub-study: will analyse the changes in quality of life associated with the intervention