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New treatment option for Healthy Aging
Official title Impact 360 for Healthy Agers
ClinicalTrials.gov ID: NCT06516146
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Participants who are able to complete questionnaires and follow directions for interventions
- Have access to a smartphone that can support the Fitbit app
You likely can't join if
- 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
See the full eligibility criteria
- 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)
- people who are pregnant or breastfeeding
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.