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NCT Number: NCT06516146

Impact 360 for Healthy Agers

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.

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Key information

Conditions

Healthy Aging Behavior Motor Activity

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

The intervention will involve online (via University of British Colombia (UBC) Zoom videoconferencing) 1-hour moderate to high intensity exercise classes 3 times a week for 6 months

Meditation

Behavioral

The intervention will involve 15 minute guided mediation following exercise classes as well as mindfulness classes.

Mindfulness classes will consist of 1.5 hour Mindfulness Based Stress Reduction (MBSR) classes for the first 2 months, followed by 1 month of 1 hour bi-weekly discussions and practice, then MBSR 2.0 for months 4 and 5, and 1 hour bi-weekly discussions and practice for the remaining month of the intervention.

Diet

Behavioral

The intervention will involve biweekly 1-hour nutrition and cooking classes with a dietician.

Primary outcomes

  1. Cognition - NIH Toolbox Cognitive Battery

    Time frame: 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.

  2. Cognition- Montreal Cognitive Assessment

    Time frame: 6 Months

    Cognition will be measured using the Montreal Cognitive Assessment (MoCA). Testing is done pre- and post-intervention to compare scores.

  3. Cognition- Parkinson's Disease Cognitive Rating Scale

    Time frame: 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.

  4. Inflammation and Biomarkers in Serum- High Sensitivity C-Reactive Protein

    Time frame: 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.

  5. Inflammation and Biomarkers in Serum - Interleukin-1β

    Time frame: 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.

  6. Inflammation and Biomarkers in Serum - Interleukin-6

    Time frame: 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.

  7. Inflammation and Biomarkers in Serum - Tumour Necrosis Factor Alpha

    Time frame: 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.

  8. Inflammation and Biomarkers in Serum - Interleukin-8

    Time frame: 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.

  9. Inflammation and Biomarkers in Serum - Interleukin-10

    Time frame: 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.

  10. Inflammation and Biomarkers in Serum - Interleukin-18

    Time frame: 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.

  11. Inflammation and Biomarkers in Serum - Calprotectin

    Time frame: 6 Months

    Systemic inflammation will be assessed by measuring concentrations of calprotectin. Samples will be taken pre- and post-intervention to assess changes.

  12. Inflammation and Biomarkers in Serum - cortisol

    Time frame: 6 Months

    Systemic inflammation will be assessed by measuring concentrations of cortisol. Samples will be taken pre- and post-intervention to assess changes.

  13. Microbiome Diversity

    Time frame: 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.

  14. Sleep Efficiency

    Time frame: 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.

  15. Pittsburgh Sleep Quality Index

    Time frame: 6 Months

    The Pittsburgh Sleep Quality Index will be used to collect subjective sleep quality data on a monthly basis.

  16. Total Grey Matter Volume

    Time frame: 6 Months

    Total grey matter volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.

  17. Hippocampal Volume

    Time frame: 6 Months

    Hippocampal volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.

  18. White matter hyperintensities volume

    Time frame: 6 Months

    White matter hyperintensities volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.

  19. Myelin Water

    Time frame: 6 Months

    Myelin water imaging will be collected using resting state functional MRI. Testing is done pre- and post-intervention to compares scores.

  20. Functional MRI

    Time frame: 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.

  21. Maximal oxygen consumption (VO2 Max)

    Time frame: 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.

  22. Heart Rate Recovery

    Time frame: 6 Months

    Heart rate recovery will be measured using a three-minute step test. Testing is done pre- and post-intervention to compares scores.

  23. Berg Balance Assessment

    Time frame: 6 Months

    A Berg Balance Assessment will be used to measure participants balance. Testing is done pre- and post-intervention to compares scores.

  24. Dynamic Gate Index

    Time frame: 6 Months

    The Dynamic Gait Index will be used to measure participants gait. Testing is done pre- and post-intervention to compares scores.

  25. Timed Up and Go Test

    Time frame: 6 Months

    The Dynamic Gait Index will be used to measure participants gait. Testing is done pre- and post-intervention to compares scores.

  26. 30 Second Sit to Stand Test

    Time frame: 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.

  27. Dual-Energy X-Ray Absorptiometry (DEXA)

    Time frame: 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.

  28. Physical Activity Levels

    Time frame: 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.

  29. Heart Rate

    Time frame: 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.

  30. Fried Frailty Index

    Time frame: 6 Months

    Physical frailty will be assessed using the fried frailty index. Testing is done pre- and post-intervention to compares scores.

  31. Blood Pressure

    Time frame: 6 Months

    Blood pressure will be measured pre- and post-intervention to compares scores.

  32. Weight

    Time frame: 6 Months

    Weight will be measured pre- and post-intervention to compares scores.

  33. Framingham Risk Score

    Time frame: 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.

  34. NIH Toolbox- Emotional Battery

    Time frame: 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.

  35. World Health Organization (WHO) Quality of Life Questionnaire

    Time frame: 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.

  36. Freiburg Mindfulness Inventory

    Time frame: 6 Months

    Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.

  37. Mindful Attention Awareness Scale

    Time frame: 6 Months

    Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.

  38. Multidimensional Assessment of Interoceptive Awareness

    Time frame: 6 Months

    Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.

Study contacts

Contact information is provided by the study sponsor or research team.

Annie Kuan

CONTACT

[email protected]

(604) 827-0576

Jeffrey Kelly, MSc

CONTACT

[email protected]

6048274230

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • The Jack and Darlene Poole Foundation

Registry information

Official study title

Impact 360 Study for Healthy Agers

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 23, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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