Table 1 Assessments at baseline (BA) and at follow-up (FUA) indicating primary (1°) and secondary (2°) outcomes (O)

Sociodemographics

Marital status, education, occupation, socioeconomic status, gender, ethnicity

General health and function

Past medical and Parkinson’s disease history, medication use, social history (place and type of residence, help with activities of daily living, smoking, alcohol use, use of walking and visual aids)

Osteoporosis risk factors are recorded according to the WHO Fracture Risk Assessment Tool (FRAX tool) [29] and the QFRACTURE [30] risk algorithm.

Measurement of frailty status using the CSHA Clinical Frailty Scale [31] and the criteria proposed by Fried et al. [32] measuring weight loss, physical activity, grip strength, walk speed and self-reported fatigue.

Self-reported physical activity measured using the Physical Activity Scale for the Elderly (PASE) [33]

Quality of life

ED-5D-5 L is widely used quality of life instrument which can be used for estimating QALYs for economic evaluations [34].

Cognitive assessments

Cognition will be assessed using the Montreal Cognitive Assessment (MOCA) [35]

Cognitive Failures Questionnaire (CFQ) [36]

Test Your Memory (TYM) [37]

Frontal Assessment Battery (FAB) [38]

The 15 item Geriatric Depression Score will be used to measure mood [39].

Physical assessment

Physical examination and electrocardiogram

Gait assessment using triaxial accelerometer with and without concurrent cognitive tasks

Freezing of gait will be assessed with the specific gait task designed to elicit freezing as well as the Freezing of Gait Questionnaire [40].

Coordinated stability – a measure of controlled leaning balance [41].

Physiological Profile Assessment containing 5 validated measures of physiological function: visual contrast sensitivity, proprioception, quadriceps strength, simple reaction time, and postural sway while standing on a foam rubber mat with eyes open [42].

Parkinson’s disease fall risk score comprised of 3 validated measures quadriceps strength, coordinated stability and freezing of gait [43].

Parkinson’s disease severity will be measured using the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale [44].

Falls, resultant injuries and adverse events

Falls, injuries and use of medical services will be collected by monthly phone calls and diaries.

Adverse events will be screened for during monthly follow-up phone calls