Promoting Independence in Lewy Body Dementia through Exercise

Summary: The pride trial involves two sections; a cross-sectional baseline study taking place at the place of residence of the participant with LBD, and a 16-week fixed period controlled crossover trial consisting of 8-weeks usual care (baseline control) followed by 8-weeks exercise intervention. The cross-sectional baseline study will evaluate covariates of functional independence (via the MDS-UPDRS measure) in a cohort of community dwelling and assisted living participant with LBD and aims to identify correlates that are potentially amenable with a targeted exercise intervention. Correlates that will be analysed include assessments of IADLs (ALSAR), ADLs (Bayer-informant), Other measures of functional independence (FIM), demographics (including pet care), body composition (BIA, weight, height, Waist circumference), Orthostatic blood pressure, static (SPPB) and dynamic balance (Tandem walk), gait stability (Axivity, AX3 monitors), gait speed (habitual and fast), walking endurance (6MWT, Step on spot test, 6MWT), physical activity levels and sedentary behaviour (Axivity, AX3 monitors), cognition (PD-CRS, Trail making, reaction time) and visual processing (Hooper Visual integration test, BVRT), upper and lower limb strength and power (Dynamometer assessment of major muscle groups, sit-to-stand test, grip strength), disease status (Clinical dementia rating), medication use, home environment assessment, nutritional assessment (Mini Nutritional assessment) and falls history. Participant Affect, Life-space and Quality of Life (DEM-QOL, GDS, SWLS, LSA) as well as caregiver affect, burden and Quality of life (PANAS, QOLS, NPI, ZARIT-12item) will also be assessed. A subset of these measures will form the primary and secondary outcomes evaluated in the 16-week fixed period controlled crossover trial (detailed in outcomes section). A community dwelling subset of individuals will then be offered the opportunity to take place in the 16-week fixed period controlled crossover trial involving exercise intervention to evaluate the effects of a targeted exercise intervention on functional independence (MDS-UPDRS) in participants living with LBD. The exercise intervention will involve cueing, strength, balance, dual-tasking and mindfulness components delivered in the clinic at the Cumberland Campus of the University of Sydney (Lidcombe, NSW) by trained exercise professionals in one hour sessions, 3 sessions/week for 8-weeks This will be supplemented by strategies tailored to each participant to increase incidental physical activity outside of the training sessions. Intervention specific details: - Mode of Delivery: Face-to-face sessions delivered in small groups of participants with the assistance of caregivers - Location of intervention: The Intervention will take place at the Cumberland campus of the University of Sydney in Lidcombe, NSW, Australia. The home baseline cross-sectional assessments will take place at the Individual's place of residence, while all follow up assessments will take place at the Lidcombe campus. - Materials / equipment used: The Exercise prescription consisting of cueing, balance, strength, dual-tasking and mindfulness components will use Keiser pneumatic strength machines, a clinical treadmill, audio and visual cueing devices such as metronomes, verbal feedback and visual instructions. Additional assessment equipment include ultra-timer gait devices, and dynamometers for measurement of static strength. - Types of activities: Those activities listed previously will be adjusted to each individual depending on ability and need based upon the individual and cohort results from assessment and current best practice in Parkinson's disease populations. This approach is a 3-tiered approach as described below: +Tier 1 prescription (modality, duration, etc.) is informed from a literature review of current best practice in Parkinson’s disease as well as dementia populations. No statistical analysis will be performed in this tier. This will occur prior to the PRIDE exercise intervention commencing. +Tier 2 will be informed from evaluation of linear regression models for each of the co-variables in the baseline cross-sectional study. Those variables with highest correlation with functional independence measures and that are potentially amenable to exercise will provide a priority for the order and focus on modalities used in the intervention. This process will be an ongoing process informed by the gradual addition of data from participants entering the cross-sectional baseline assessment. +Tier 3 will be fine adjustments for each individual based on medical history, functional capacity and cognitive ability. No statistical analysis will be performed in this tier. This process will be finalised after Baseline assessment and review by Study physician Prof. Fiatarone Singh. The resultant program will resemble a combination of interventions reported in Parkinson's disease with priority in order given to those that best target the mediating factors identified in the Baseline cross-sectional study. Each program will then be modified to best elicit exercise gains in the individual taking into consideration their current ability and limitations. Physical activity adoption strategies: This process will be dependent on the results of the cross-sectional baseline study. The levels of physical activity and sedentary times will be analysed during the usual care control period and compared to similar cohorts in Parkinson's disease and healthy age-matched control cohorts. Targets will be set as part of the exercise prescription to increase incidental physical activity using small, but incremental increases in daily PA (i.e. integrating walks into the daily routine, intervening long sedentary periods with shorts periods of standing, etc). Adherence and Fidelity: This will be measured through percentage completion of full protocol sessions. We will record attendance at these sessions as well as specific components of adherence including number of exercises performed, amount of weight lifted, difficulty levels of balance exercises, heart rate during aerobic activities and perceived exertion during aerobic and strengthening exercises. We will also record any other open ended feedback on their perceptions of enjoyment or discomfort, etc. Adverse events: We will capture all adverse events during the intervention and assessment periods. This will be achieved by weekly questionnaire/interview including proxy information obtained whenever necessary to minimize missing data. Adverse events will include any exacerbation of underlying disease, or new onset musculoskeletal, cardiovascular, or metabolic abnormality attributed directly to study protocols. Specific adverse events that will be routinely monitored include: falls, cardiac events during physical testing and exercise training (angina, arrhythmias, blood pressure excursions, clinically significant ECG changes); fatigue and muscle soreness or musculoskeletal injury following training; In addition, subjects will be asked to report all changes in medication, health care professional visits, new diagnoses, acute illnesses, or any new symptoms.