Feasibility and Safety of the AHA Exergame System in Parkinson's Disease Patients: a Mixed Methods Study

1. Background Parkinson's disease (PD) is a neurological disorder, characterized by the presence of motor and non-motor symptoms that negatively affects patients' quality of life. (1,2) Despite optimal medical treatment, patients develop a progressive disability that usually shapes a sedentary lifestyle, which is a risk factor for cardiovascular disease, diabetes mellitus, cognitive impairment, osteoporosis, and depression. (1,3,4) In the past years, physiotherapy and exercise have been recommended for symptomatic control and as a strategy to reverse PD patients' sedentary lifestyles. (2,5) However, results from previous studies showed that physiotherapy programs only provide a short-term benefit and it still a challenge the implementation of unsupervised home-based exercise. (3,6) Exergames are video games to exercise, based on gross physical movements of the player, that combine real-time motion detection with engaging games. (7,8) They have been described as a therapeutic tool that includes functional, purposeful and appealing exercise, with positive effects in neurological diseases and older adults. (7,8) Exergames promote an integrated motor and cognitive stimulation, providing biofeedback, enhancing game performance and learning of the virtual tasks with transference to real conditions and its home-based characteristics. Based on this, exergames have been proposed as a complement to physiotherapy programs, in order to improve PD motor symptoms. (7,8) However, they should be specifically tailored to address PD functional needs, in order to optimize efficacy, adherence, and safety. (8) This study aims to evaluate the feasibility and safety of an exergames system design for PD patients.
2. Participants and methods

Study design A feasibility study including two phases, one qualitative and another quantitative will be performed.

In the first phase, the qualitative study, two focus groups will be conducted (one with PD patients and other with a group of physiotherapists), to discuss the accessibility and usability of the exergames to be tested and the exercise-based computer games for people with PD. The second phase, the quantitative study, will be a single-center, open-label, feasibility, and usability study.

Patients recruitment PD patients will be recruited from the Campus Neurológico Sénior (CNS) institution to participate either in the qualitative phase or in the quantitative phase. Patients will be included if they were: 1) idiopathic PD patients according to the UKBB criteria; 2) age between 40-80 years old; 3) with a Hoehn Yahr Stage (HY) 1 or 2 in MED ON; 4) ability to walk independently without risk of falling; 5) a Mini-mental state score > 24; 6) ability to communicate with the investigator, to understand and comply with the requirements of the study; and lastly 7) ability to provide written informed consent to participate in the study.

Patients will be excluded if they had an atypical parkinsonian syndrome. Physiotherapists will be also screened and recruited from the CNS institution. The Local Ethical Committee approved the study (Ref. 9/2017). All included patients and physiotherapists will provide informed consent, before enrolling in any study procedure.