Lifestyle Intervention Study for Dementia Risk Reduction in Healthy Adults Aged Over 50 Years - The LEISURE study

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2020
INTERVENTION: Lifestyle Intervention program (LIFE) The LIFE program is a personalised multimodal lifestyle intervention designed to reduce modifiable risk factors for dementia. The LIFE program integrates exercise, diet, mindfulness, and sleep components into a comprehensive intervention specifically targeted towards metabolic, inflammatory, and neurogenic biological pathways supportive of healthy brain ageing. The LIFE program will be individually tailored to each participants’ needs across the four intervention components. Each component of the LIFE program is detailed below. Exercise program The exercise intervention will consist of a mixed‐mode training program incorporating both supervised and unsupervised exercise. All sessions will be performed in a fitness setting with qualified personal trainers for participant supervision and instruction. Following baseline assessment and randomisation, participants will complete an introductory session with an Exercise Physiologist to assess baseline strength, educate participants on equipment use, safety, individualise the program as necessary and complete a supervised run‐through of the program. Participants will complete three, 60‐min exercise training sessions per week for 12 weeks. Participants will complete one supervised session with an exercise professional per week in a small‐group setting. The other two sessions per week will be completed unsupervised, with general audio‐visual guidance provided in the exercise setting. Each session will include a 10‐min warm‐up, followed by 4‐6 individually‐prescribed whole‐body exercises performed at a moderate intensity in a circuit‐based format with minimal rest (rating of perceived exertion, Borg Scale 10‐15). Resistance weight, sets, and repetitions will be CONDITION: Dementia; ; Dementia Neurological ‐ Dementias PRIMARY OUTCOME: HBA Dementia Risk Profile Report[Post 12‐week intervention] INCLUSION CRITERIA: 1. Individuals aged 50‐85 years with a Montreal Cognitive Assessment (MoCA) score of 26 or greater; 2. Availability to complete all testing, training, and home practice requirements; 3. Normal or corrected‐to‐normal visual acuity; 4. Pass MRI safety checklist. SECONDARY OUTCOME: Change fitness as measured by a 6‐minute walk test[Post 12‐week intervention] Change in aspects of quality of life as measured by the Assessment of Quality of Life (AQoL)‐8D[Post 12‐week intervention] Change in attentional performance as measured by the Cambridge Neuropsychological Test Automated Battery (CANTAB)[Post 12‐week intervention] Change in auditory‐verbal memory assessed by Rey Auditory Verbal Learning Test[Post 12‐week intervention] Change in blood biomarker profile as measured by Enzyme‐linked immunosorbent assay (ELISA)[Post 12‐week intervention] Change in cerebrovascular function as measured by transcranial doppler (TCD)[Post 12‐week intervention] Change in depressive symptoms assessed by Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH‐D).[Post 12‐week intervention] Change in diet quality as measured by 7‐day food diary[Post 12‐week intervention] Change in EEG Event‐related Potential (ERP) as measured by 32‐channel EEG system[Post 12‐week intervention] Change in Electroencephalogram (EEG) power and connectivity as measured by 32‐channel EEG system[Post 12‐week intervention] Change in global cognitive function assessed by Montreal Cognitive Assessment (MoCA).[Post 12‐week intervention] Change in health resource use as measured by the Health Resource Use Questionnaire[Post 12‐week intervention] Change in inhibitory control performance assessed by D‐KEFS Colour –Word Interference Test. [Post 12‐week intervention] Change in insulin resistance as measured by Homeostatic Model Assessment for Insulin Resistance (HOMA‐IR) score[Post 12‐week intervention] Change in leg strength as measured by sit‐to‐stand test[Post 12‐week intervention] Change in memory assessed by WMS‐IV Logical Memory I and II (Wechsler Memory Scale, IV). [Post 12‐week intervention] Change in mindfulness as measured by breath counting task[Post 12‐week intervention] Change in neurometabolites as assessed by Magnetic resonance spectroscopy (MRS) [Post 12‐week intervention] Change in perceived cognitive difficulties assessed by British Columbia Cognitive Complaints Inventory (BC‐CCI).[Post 12‐week intervention] Change in reaction time to ERP task target stimuli as measured in milliseconds[Post 12‐week intervention] Change in regional brain volumes as assessed by structural MRI scan[Post 12‐week intervention] Change in sleep duration as determined by actigraphy monitoring and 7‐day sleep diary completion[Post 12‐week intervention] Change in sleep onset latency defined by actigraphy and 7‐day sleep diary[Post 12‐week intervention] Change in sleep quality as determined by actigraphy monitoring and 7‐day sleep diary completion[Post 12‐week intervention] Change in strength as measured by the grip strength test[Post 12‐week intervention] Change in symptoms of anxiety assessed by State/Trait Anxiety Inventory.[Post 12‐week intervention] Change in verbal fluency assessed by Controlled Oral Word Association Test[Post 12‐week intervention] Change in visual attention and task switching assessed using the Trail making test. [Post 12‐week intervention] Change in visuospatial memory assessed by Rey Complex Figure Test[Post 12‐week intervention] Change in word retrieval assessed by Boston Naming Test.[Post 12‐week intervention] Change in working memory capacity assessed by Digit Span subtest (Wechsler Adult Intelligence Scale, IV)[Post 12‐week intervention] Changed glymphatic flow as assessed by cardiac flow MRI scan[Post 12‐week intervention] Changed resting state functional network activation as assessed by resting state functional MRI scan[Post 12‐week intervention] Changed white matter connectivity as assessed by Diffusion Tensor Imaging (DTI) MRI scan[Post 12‐week intervention] Improved response accuracy to ERP task target stimuli as measured by percent correct responses[Post 12‐week intervention]
Epistemonikos ID: 21cb3f6b82a9c7c3dad47889ad980edc32689907
First added on: Aug 24, 2024