Impact 360 for Healthy Agers

University of British Columbia

Status: Enrolling

Conditions: Healthy Aging

Treatments: Behavioral: Exercise; Behavioral: Diet; Behavioral: Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT06516146

H21-01750

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Exercise, Diet, Mindfulness

Experimental group

Description:

The intervention group will start the intervention immediately following their baseline assessment. They will undergo another assessment after the 6 month intervention period.

Treatment:

Behavioral: Meditation

Behavioral: Diet

Behavioral: Exercise

Waitlist Group

No Intervention group

Description:

Participants randomized into the waitlist group will undergo a baseline assessment, and will then be encouraged to continue their daily activities as usual for 6 months. Physical activity and sleep will be monitored during this time using wearable devices. Links to questionnaires will be emailed monthly. After the 6-month waitlist period, participants will undergo a second assessment prior to starting the intervention. The multimodal intervention will be 6-months in length, using the same measures of adherence, and will be followed by a final assessment.