Impact 360 Study for Healthy Agers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mindful Attention Awareness Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are able to complete questionnaires and follow directions for interventions
- •Have access to a smartphone that can support the Fitbit app
排除标准
- •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
结局指标
主要结局
Mindful Attention Awareness Scale
时间窗: 6 Months
Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
Inflammation and Biomarkers in Serum- High Sensitivity C-Reactive Protein
时间窗: 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.
Cognition- Parkinson's Disease Cognitive Rating Scale
时间窗: 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
时间窗: 6 Months
The Pittsburgh Sleep Quality Index will be used to collect subjective sleep quality data on a monthly basis.
Total Grey Matter Volume
时间窗: 6 Months
Total grey matter volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.
Hippocampal Volume
时间窗: 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 - Interleukin-6
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 6 Months
Blood pressure will be measured pre- and post-intervention to compares scores.
Weight
时间窗: 6 Months
Weight will be measured pre- and post-intervention to compares scores.
Cognition- Montreal Cognitive Assessment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 6 Months
Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
White matter hyperintensities volume
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 6 Months
Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
30 Second Sit to Stand Test
时间窗: 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.
次要结局
未报告次要终点
研究者
Silke Cresswell
Principal Investigator
University of British Columbia