About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants who are able to complete questionnaires and follow directions for interventions
Have access to a smartphone that can support the Fitbit app
Disqualifiers
Any neurological disease/disorder diagnosis (Ex: Parkinson's Disease, Multiple Sclerosis, Traumatic Brain Injury, Brain lesion, Stroke, etc)
Any chronic medical condition which would affect ability to participate in exercise
Any contraindication for exercise based on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and medical clearance form
Participants who were told by a medical doctor that they need to be medically supervised for exercise
Trial design
Crossover
Treatments tested in this trial
Exercise
BehavioralThe intervention will involve online (via University of British Colombia (UBC) Zoom videoconferencing) 1-hour moderate to high intensity exercise classes 3 times a week for 6 months
Meditation
BehavioralThe intervention will involve 15 minute guided mediation following exercise classes as well as mindfulness classes. Mindfulness classes will consist of 1.5 hour Mindfulness Based Stress Reduction (MBSR) classes for the first 2 months, followed by 1 month of 1 hour bi-weekly discussions and practice, then MBSR 2.0 for months 4 and 5, and 1 hour bi-weekly discussions and practice for the remaining month of the intervention.
Diet
BehavioralThe intervention will involve biweekly 1-hour nutrition and cooking classes with a dietician.
Treatment groups
Trial outcomes
Primary outcomes
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.
Cognition- Montreal Cognitive Assessment
Cognition will be measured using the Montreal Cognitive Assessment (MoCA). Testing is done pre- and post-intervention to compare scores.
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.
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.
Sponsors and contacts
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University of British Columbia
Lead sponsor
The Jack and Darlene Poole Foundation
Collaborator