Clinical trial NCT06516146: Impact 360 for Healthy Agers
Official title: Impact 360 Study for Healthy Agers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Aging
Keywords: Exercise
Mindfulness
Microbiome
Well-Being
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: The Jack and Darlene Poole Foundation
First posted: 2024-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Adults 50-75 years of age without a diagnosis of a neurodegenerative condition, will be recruited and screened for eligibility. Sixty participants will be randomly assigned to the waitlist group or the intervention group and will be striated into cohorts blocks. Each cohort block will start the intervention at the same time and will participate in the intervention together. This will allow for social interaction, engagement with their peers, and hopefully encouraging better adherence.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Participants who are able to complete questionnaires and follow directions for interventions
* Have access to a smartphone that can support the Fitbit app

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cognition - NIH Toolbox Cognitive Battery
timeFrame: 6 Months
measure: Cognition- Montreal Cognitive Assessment
timeFrame: 6 Months
measure: Cognition- Parkinson's Disease Cognitive Rating Scale
timeFrame: 6 Months
measure: Inflammation and Biomarkers in Serum- High Sensitivity C-Reactive Protein
timeFrame: 6 Months
measure: Inflammation and Biomarkers in Serum - Interleukin-1β
timeFrame: 6 Months
measure: Inflammation and Biomarkers in Serum - Interleukin-6
timeFrame: 6 Months
measure: Inflammation and Biomarkers in Serum - Tumour Necrosis Factor Alpha
timeFrame: 6 Months
measure: Inflammation and Biomarkers in Serum - Interleukin-8
timeFrame: 6 Months
measure: Inflammation and Biomarkers in Serum - Interleukin-10
timeFrame: 6 Months
measure: Inflammation and Biomarkers in Serum - Interleukin-18
timeFrame: 6 Months
measure: Inflammation and Biomarkers in Serum - Calprotectin
timeFrame: 6 Months
measure: Inflammation and Biomarkers in Serum - cortisol
timeFrame: 6 Months
measure: Microbiome Diversity
timeFrame: 6 Months
measure: Sleep Efficiency
timeFrame: 6 Months
measure: Pittsburgh Sleep Quality Index
timeFrame: 6 Months
measure: Total Grey Matter Volume
timeFrame: 6 Months
measure: Hippocampal Volume
timeFrame: 6 Months
measure: White matter hyperintensities volume
timeFrame: 6 Months
measure: Myelin Water
timeFrame: 6 Months
measure: Functional MRI
timeFrame: 6 Months
measure: Maximal oxygen consumption (VO2 Max)
timeFrame: 6 Months
measure: Heart Rate Recovery
timeFrame: 6 Months
measure: Berg Balance Assessment
timeFrame: 6 Months
measure: Dynamic Gate Index
timeFrame: 6 Months
measure: Timed Up and Go Test
timeFrame: 6 Months
measure: 30 Second Sit to Stand Test
timeFrame: 6 Months
measure: Dual-Energy X-Ray Absorptiometry (DEXA)
timeFrame: 6-Months
measure: Physical Activity Levels
timeFrame: 6 Months
measure: Heart Rate
timeFrame: 6 Months
measure: Fried Frailty Index
timeFrame: 6 Months
measure: Blood Pressure
timeFrame: 6 Months
measure: Weight
timeFrame: 6 Months
measure: Framingham Risk Score
timeFrame: 6 Months
measure: NIH Toolbox- Emotional Battery
timeFrame: 6 Months
measure: World Health Organization (WHO) Quality of Life Questionnaire
timeFrame: 6 Months
measure: Freiburg Mindfulness Inventory
timeFrame: 6 Months
measure: Mindful Attention Awareness Scale
timeFrame: 6 Months
measure: Multidimensional Assessment of Interoceptive Awareness
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Colombia
state: British Columbia
Study officials:
affiliation: University of British Colombia
name: Silke Appel-Cresswell, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: