Impact 360 for Healthy Agers
- Conditions
- Healthy Aging
- Interventions
- Behavioral: ExerciseBehavioral: MeditationBehavioral: Diet
- Registration Number
- NCT06516146
- Lead Sponsor
- University of British Columbia
- Brief 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.
- Detailed Description
Current research suggests that exercise, meditation, and nutrition have neuroprotective effects although there is still a lack of pharmacological therapies to prevent or slow down disease progression. The benefits of these individual interventions have been shown, but emerging evidence suggests that combined interventions are more powerful than isolated ones. The crucial next step is to study the impact of a multimodal program on brain health and to comprehensively examine underlying mechanisms.
The comprehensive assessment ("360 degree approach") will focus on 8 key areas of health: cognition, inflammation, microbiome diversity, sleep quality, neurological imaging markers, physical fitness, cardiovascular health, and social and mental well-being. This comprehensive assessment in this healthy aging cohort will serve two purposes: 1) Help us to understand the mechanisms behind the benefits of this multimodal intervention and how the interactive effects influence one's overall health and 2) to serve as a normative dataset for replication of this study in clinical populations (e.g. Parkinson's disease, Alzheimer's disease, stroke)
The objective of this study is to explore the effects of this combined intervention on overall health. The investigators aim to discover the mechanisms of action behind the benefits of this multimodal intervention. The investigators will assess the impact of the intervention on overall health using the following 8 key indicators of overall health: cognition, inflammation and biomarkers, gut microbiome diversity, sleep quality, Magnetic Resonance Imaging (MRI) neurological markers, cardiorespiratory fitness and physical health, cardiovascular disease risk factors, and emotional well-being.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Participants who are able to complete questionnaires and follow directions for interventions
- Have access to a smartphone that can support the Fitbit app
- 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
- Montreal Cognitive Assessment (MoCA) scores <21/30
- Significant cognitive impairment, depression, or eating disorder
- Any contraindication to MRI scanning; such as implanted metal clips or wires (see list below)
- Participants currently doing 180 minutes or more of moderate-vigorous intensity exercise per week AND either of the following:
- Completion of an Mindfulness-Based Stress Reduction course OR; Score >8/15 in the Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) Diet Questionnaire
- Significant or unstable cardiovascular or respiratory disease
- Severe/multiple head trauma(s)
- Subjects who are pregnant or breastfeeding
- Subjects with a history or major episodes of drug or alcohol abuse
- Chronic/acute bacterial/viral infection
- GI cancer
- Inflammatory bowel disease
Exclusion for MRI scanning:
- Individuals weighing > 400 lbs (limit of MRI machine)
- Artificial heart valve
- Brain aneurysm clip
- Electrical stimulator for nerves or bones
- Ear or eye implant
- Implanted drug infusion pump
- Coil, catheter, or filter in any blood vessel
- Orthopedic hardware (artificial joint, plate, screws)
- Other metallic prostheses
- Shrapnel, bullets, or other metal fragments
- Surgery or tattoos (including tattooed eyeliner) in the last six weeks
- Brain surgery
- Have a cardiac pacemaker, wires or defibrillator
- Have had an injury where a piece of metal lodged in the eye or orbit
- Have a ferromagnetic aneurysm clip
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Exercise, Diet, Mindfulness Meditation The intervention group will start the intervention immediately following their baseline assessment. They will undergo another assessment after the 6 month intervention period. Exercise, Diet, Mindfulness Diet The intervention group will start the intervention immediately following their baseline assessment. They will undergo another assessment after the 6 month intervention period. Exercise, Diet, Mindfulness Exercise The intervention group will start the intervention immediately following their baseline assessment. They will undergo another assessment after the 6 month intervention period.
- Primary Outcome Measures
Name Time Method Mindful Attention Awareness Scale 6 Months Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
Cognition- Parkinson's Disease Cognitive Rating Scale 6 Months Cognition will be measured using the Parkinson's Disease Cognitive Rating Scale (PD-CRS). Testing is done pre- and post-intervention to compare scores.
Pittsburgh Sleep Quality Index 6 Months The Pittsburgh Sleep Quality Index will be used to collect subjective sleep quality data on a monthly basis.
Total Grey Matter Volume 6 Months Total grey matter volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.
Hippocampal Volume 6 Months Hippocampal volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.
Inflammation and Biomarkers in Serum- High Sensitivity C-Reactive Protein 6 Months 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.
Inflammation and Biomarkers in Serum - Interleukin-6 6 Months Systemic inflammation will be assessed by measuring concentrations of interleukin-6 (IL-6). Samples will be taken pre- and post-intervention to assess changes.
Inflammation and Biomarkers in Serum - Interleukin-8 6 Months Systemic inflammation will be assessed by measuring concentrations of interleukin-8 (IL-8). Samples will be taken pre- and post-intervention to assess changes.
Inflammation and Biomarkers in Serum - Interleukin-10 6 Months Systemic inflammation will be assessed by measuring concentrations of interleukin-10 (IL-10). Samples will be taken pre- and post-intervention to assess changes.
Inflammation and Biomarkers in Serum - Interleukin-18 6 Months Systemic inflammation will be assessed by measuring concentrations of interleukin-18 (IL-18). Samples will be taken pre- and post-intervention to assess changes.
Sleep Efficiency 6 Months 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.
Myelin Water 6 Months Myelin water imaging will be collected using resting state functional MRI. Testing is done pre- and post-intervention to compares scores.
Dynamic Gate Index 6 Months The Dynamic Gait Index will be used to measure participants gait. Testing is done pre- and post-intervention to compares scores.
Cognition - NIH Toolbox Cognitive Battery 6 Months 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.
Inflammation and Biomarkers in Serum - Tumour Necrosis Factor Alpha 6 Months 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.
Functional MRI 6 Months 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.
Berg Balance Assessment 6 Months A Berg Balance Assessment will be used to measure participants balance. Testing is done pre- and post-intervention to compares scores.
Physical Activity Levels 6 Months 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.
Heart Rate 6 Months 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.
Blood Pressure 6 Months Blood pressure will be measured pre- and post-intervention to compares scores.
Weight 6 Months Weight will be measured pre- and post-intervention to compares scores.
Cognition- Montreal Cognitive Assessment 6 Months Cognition will be measured using the Montreal Cognitive Assessment (MoCA). Testing is done pre- and post-intervention to compare scores.
Inflammation and Biomarkers in Serum - Interleukin-1β 6 Months Systemic inflammation will be assessed by measuring concentrations of interleukin-1β (IL-1β). Samples will be taken pre- and post-intervention to assess changes.
Inflammation and Biomarkers in Serum - Calprotectin 6 Months Systemic inflammation will be assessed by measuring concentrations of calprotectin. Samples will be taken pre- and post-intervention to assess changes.
Inflammation and Biomarkers in Serum - cortisol 6 Months Systemic inflammation will be assessed by measuring concentrations of cortisol. Samples will be taken pre- and post-intervention to assess changes.
Microbiome Diversity 6 Months 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.
Heart Rate Recovery 6 Months Heart rate recovery will be measured using a three-minute step test. Testing is done pre- and post-intervention to compares scores.
Timed Up and Go Test 6 Months The Dynamic Gait Index will be used to measure participants gait. Testing is done pre- and post-intervention to compares scores.
Fried Frailty Index 6 Months Physical frailty will be assessed using the fried frailty index. Testing is done pre- and post-intervention to compares scores.
Framingham Risk Score 6 Months 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.
Freiburg Mindfulness Inventory 6 Months Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
White matter hyperintensities volume 6 Months White matter hyperintensities volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.
Maximal oxygen consumption (VO2 Max) 6 Months Predicted maximal oxygen consumption will be measured using a six-minute walk test. Testing is done pre- and post-intervention to compares scores.
Dual-Energy X-Ray Absorptiometry (DEXA) 6-Months 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.
NIH Toolbox- Emotional Battery 6 Months 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.
World Health Organization (WHO) Quality of Life Questionnaire 6 Months 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.
Multidimensional Assessment of Interoceptive Awareness 6 Months Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
30 Second Sit to Stand Test 6 Months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of British Colombia
🇨🇦Vancouver, British Columbia, Canada