Cognitive and Physical Home-rehabilitation by Information and Communications Technology. Games for Older Adults Active Life (GOAL)
Condition: Cognitive Dysfunction; Mild Cognitive Impairment; Vascular Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Aging is often associated with pathological pathway such as in Mild Cognitive Impairment
      (MCI), and that pathway may be associated to a high risk of dementia.

      Tools for early identification of functional and cognitive decline and effectiveness of
      treatments in counteracting the loss of functionality to preserve MCI subjects autonomy, have
      been widely debated in recent years.

      In literature, the importance of combined cognitive and physical training is also recognized
      (Karssemeijer E, 2017).

      Moving from the above mentioned findings and considerations, the aim of GOAL project is to
      test a newly developed tele-rehabilitation platform to monitor and preserve functional and
      cognitive abilities in individuals affected by Mild Cognitive Impairment (MCI).

      Participants will be enrolled and randomly assigned to the tele-rehabilitation (GOAL group)
      or usual care program (control group). A dedicated application will be developed for the GOAL
      group. Thanks to the application, the participant will access different contents, such as
      serious games to train cognitive abilities (Anguera et al,2013) and physical training video
      lessons to endorse daily activity. Each participant of GOAL group will be provided with a
      tablet, with the application installed on it, and an internet connection (if needed).
    

Detailed description: 
      30 patients will be allocated in the treatment arm (Telerehabilitation program, GOAL group)
      by randomization. Randomization will be applied with a ratio of 1:1.

      The Telerehabilitation program is conceived as a combined protocol to train both cognitive
      and physical domains. Participants will be requested to perform the cognitive training three
      times weekly and physical training two times weekly, on alternate days. The subject will
      access the Telerehabilitation contents by using a web application configured on a touchscreen
      notebook, that will be provided to each participant by the research institute.

      Physical exercises are going to be chosen according to adaptive physical activity model, and
      each session will be made up of eleven exercises, divided in three categories: warm-up,
      strengthening and stretching/relaxation. The participants will perform the exercises
      according to instructions received in a sequence of videos. Every session will last 30
      minutes.

      Cognitive training will be based on BrainHQ exercises (BrainHQ, Posit Science,USA) which are
      characterized by adaptive control of the difficulty levels. The chosen exercises aim to train
      different cognitive domains including: attention, executive function, memory, processing
      speed, reasoning, and visuospatial memory. Each session will last 20 minutes, and will
      include four different types of exercise.

      While enrolled in the 8 weeks program, participants will also be requested to wear an
      actigraph. The actigraph will be placed on the non-dominant arm and will be used to monitor
      daily activity and sleep quality.

      At the end of the tele-rehabilitation program, participants will undergo a final assessment.
    

Intervention name(s): Tele-rehabilitation
Intervention type(s): Other
Intervention description(s): Each subject undergoes a combined rehabilitation protocol, which will be administered on a daily basis, designed to alternate physical exercises and cognitive training. Each daily session lasts between 30 and 45 minutes. The complete protocol lasts 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Telerehabilitation [E02.831.891]; Cognitive Aging [G07.345.124.260]; Exercise Therapy [E02.760.169.063.500.387]