Impact 360 for Healthy Agers
NCT Number: NCT06516146
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Aging
Interventions: BEHAVIORAL: Exercise|BEHAVIORAL: Meditation|BEHAVIORAL: Diet
Sponsor: University of British Columbia
Collaborators: The Jack and Darlene Poole Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-24
Completion Date: 2025-01-05
Locations: University of British Colombia, Vancouver, British Columbia, V6T 1Z3, Canada

Summary:
The Impact 360 study will evaluate the effects of a combined intervention of exercise, mindfulness, and nutrition on 8 key indicators of health and the mechanisms that drive these changes. 60 subjects aged 50 to 75 without a current diagnosis of a brain disorder will be recruited. This study will follow a partial crossover design. All participants will receive the intervention. Participants randomized into the intervention group after their baseline screening will receive the 6-month intervention. Those randomized into the waitlist group will complete another assessment at the end of the 6-month care as usual phase before receiving the intervention.

Primary Outcome Measures: Cognition - NIH Toolbox Cognitive Battery, Cognition will be measured using the National Institutes of Health (NIH) Toolbox Cognitive battery (NIHTB-CB). Testing is done pre- and post-intervention to compare scores., 6 Months|Cognition- Montreal Cognitive Assessment, Cognition will be measured using the Montreal Cognitive Assessment (MoCA). Testing is done pre- and post-intervention to compare scores., 6 Months|Cognition- Parkinson's Disease Cognitive Rating Scale, Cognition will be measured using the Parkinson's Disease Cognitive Rating Scale (PD-CRS). Testing is done pre- and post-intervention to compare scores., 6 Months|Inflammation and Biomarkers in Serum- High Sensitivity C-Reactive Protein, Systemic inflammation will be assessed by measuring concentrations of high sensitivity C-reactive protein (hs-CRP). Samples will be taken pre- and post-intervention to assess changes., 6 Months|Inflammation and Biomarkers in Serum - Interleukin-1β, Systemic inflammation will be assessed by measuring concentrations of interleukin-1β (IL-1β). Samples will be taken pre- and post-intervention to assess changes., 6 Months|Inflammation and Biomarkers in Serum - Interleukin-6, Systemic inflammation will be assessed by measuring concentrations of interleukin-6 (IL-6). Samples will be taken pre- and post-intervention to assess changes., 6 Months|Inflammation and Biomarkers in Serum - Tumour Necrosis Factor Alpha, Systemic inflammation will be assessed by measuring concentrations of Tumour Necrosis Factor Alpha (TNFa). Samples will be taken pre- and post-intervention to assess changes., 6 Months|Inflammation and Biomarkers in Serum - Interleukin-8, Systemic inflammation will be assessed by measuring concentrations of interleukin-8 (IL-8). Samples will be taken pre- and post-intervention to assess changes., 6 Months|Inflammation and Biomarkers in Serum - Interleukin-10, Systemic inflammation will be assessed by measuring concentrations of interleukin-10 (IL-10). Samples will be taken pre- and post-intervention to assess changes., 6 Months|Inflammation and Biomarkers in Serum - Interleukin-18, Systemic inflammation will be assessed by measuring concentrations of interleukin-18 (IL-18). Samples will be taken pre- and post-intervention to assess changes., 6 Months|Inflammation and Biomarkers in Serum - Calprotectin, Systemic inflammation will be assessed by measuring concentrations of calprotectin. Samples will be taken pre- and post-intervention to assess changes., 6 Months|Inflammation and Biomarkers in Serum - cortisol, Systemic inflammation will be assessed by measuring concentrations of cortisol. Samples will be taken pre- and post-intervention to assess changes., 6 Months|Microbiome Diversity, Stool samples will be analyzed for gut microbiome composition by shallow shotgun metagenome sequencing. Samples will be taken pre- and post-intervention to assess changes., 6 Months|Sleep Efficiency, Sleep efficiency (total sleep time/time spent in bed) will be measured through a wearable device with an accelerometer. This device will also measure other components of sleep quality such as sleep onset latency, total sleep time and wake after sleep onset., 6 Months|Pittsburgh Sleep Quality Index, The Pittsburgh Sleep Quality Index will be used to collect subjective sleep quality data on a monthly basis., 6 Months|Total Grey Matter Volume, Total grey matter volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores., 6 Months|Hippocampal Volume, Hippocampal volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores., 6 Months|White matter hyperintensities volume, White matter hyperintensities volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores., 6 Months|Myelin Water, Myelin water imaging will be collected using resting state functional MRI. Testing is done pre- and post-intervention to compares scores., 6 Months|Functional MRI, A flanker task will be administered during the MRI to examine selective attention, inhibitory function, and executive control. Testing is done pre- and post-intervention to compares scores., 6 Months|Maximal oxygen consumption (VO2 Max), Predicted maximal oxygen consumption will be measured using a six-minute walk test. Testing is done pre- and post-intervention to compares scores., 6 Months|Heart Rate Recovery, Heart rate recovery will be measured using a three-minute step test. Testing is done pre- and post-intervention to compares scores., 6 Months|Berg Balance Assessment, A Berg Balance Assessment will be used to measure participants balance. Testing is done pre- and post-intervention to compares scores., 6 Months|Dynamic Gate Index, The Dynamic Gait Index will be used to measure participants gait. Testing is done pre- and post-intervention to compares scores., 6 Months|Timed Up and Go Test, The Dynamic Gait Index will be used to measure participants gait. Testing is done pre- and post-intervention to compares scores., 6 Months|30 Second Sit to Stand Test, Functional lower extremity strength with be assessed using the 30 second sit to stand test. Testing is done pre- and post-intervention to compare scores., 6 Months|Dual-Energy X-Ray Absorptiometry (DEXA), Body composition, such as body fat and muscle mass, will be measured using Dual-energy X-ray Absorptiometry. Testing is done pre- and post-intervention to compare scores., 6-Months|Physical Activity Levels, Physical activity levels will be measured through a wearable device to help ensure adherence and effectiveness of the exercise intervention. Data will be collected throughout the study., 6 Months|Heart Rate, Heart rate will be measured through a wearable device to help ensure adherence and effectiveness of the exercise intervention. Data will be collected throughout the study., 6 Months|Fried Frailty Index, Physical frailty will be assessed using the fried frailty index. Testing is done pre- and post-intervention to compares scores., 6 Months|Blood Pressure, Blood pressure will be measured pre- and post-intervention to compares scores., 6 Months|Weight, Weight will be measured pre- and post-intervention to compares scores., 6 Months|Framingham Risk Score, Cardiovascular health will be assessed using the Framingham Risk Score. This score includes measurements of age, total cholesterol, smoking status, HDL level, diabetes status, systolic blood pressure and treatment status. Testing is done pre- and post-intervention to compares scores., 6 Months|NIH Toolbox- Emotional Battery, Social, emotional, and mental well-being will be evaluated using the NIH Toolbox-Emotional Battery. Testing is done pre- and post-intervention to compares scores., 6 Months|World Health Organization (WHO) Quality of Life Questionnaire, Quality of life will be evaluated using the World Health Organization (WHO) Quality of Life Questionnaire. Testing is done pre- and post-intervention to compares scores., 6 Months|Freiburg Mindfulness Inventory, Questionnaires related to mindfulness will be administered throughout the study at monthly intervals., 6 Months|Mindful Attention Awareness Scale, Questionnaires related to mindfulness will be administered throughout the study at monthly intervals., 6 Months|Multidimensional Assessment of Interoceptive Awareness, Questionnaires related to mindfulness will be administered throughout the study at monthly intervals., 6 Months