Impact 360 for Healthy Agers

Impact 360 Study 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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Aging
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Meditation; Behavioral: Diet

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annie Kuan; Phone Number: (604) 827-0576; Email: annie.kuan@ubc.ca
• Study Contact Backup: Name: Jeffrey Kelly, MSc; Phone Number: 6048274230; Email: jeffrey.kelly@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z3
      • Recruiting
      • University of British Colombia
      • Contact: Madeleine Powell; Phone Number: (604) 822-8691; Email: madeleine.powell@ubc.ca
      • Contact: Annie Kuan; Phone Number: (604) 827-0576; Email: annie.kuan@ubc.ca
      • Principal Investigator: Silke Appel-Cresswell, MD, FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise, Diet, Mindfulness; The intervention group will start the intervention immediately following their baseline assessment. They will undergo another assessment after the 6 month intervention period.	Behavioral: Exercise; 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; Behavioral: Meditation; 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.; Behavioral: Diet; The intervention will involve biweekly 1-hour nutrition and cooking classes with a dietician.
No Intervention: Waitlist Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition - NIH Toolbox Cognitive Battery	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.	6 Months
Cognition- Montreal Cognitive Assessment	Cognition will be measured using the Montreal Cognitive Assessment (MoCA). Testing is done pre- and post-intervention to compare scores.	6 Months
Cognition- Parkinson's Disease Cognitive Rating Scale	Cognition will be measured using the Parkinson's Disease Cognitive Rating Scale (PD-CRS). Testing is done pre- and post-intervention to compare scores.	6 Months
Inflammation and Biomarkers in Serum- High Sensitivity C-Reactive Protein	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.	6 Months
Inflammation and Biomarkers in Serum - Interleukin-1β	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 Months
Inflammation and Biomarkers in Serum - Interleukin-6	Systemic inflammation will be assessed by measuring concentrations of interleukin-6 (IL-6). Samples will be taken pre- and post-intervention to assess changes.	6 Months
Inflammation and Biomarkers in Serum - Tumour Necrosis Factor Alpha	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.	6 Months
Inflammation and Biomarkers in Serum - Interleukin-8	Systemic inflammation will be assessed by measuring concentrations of interleukin-8 (IL-8). Samples will be taken pre- and post-intervention to assess changes.	6 Months
Inflammation and Biomarkers in Serum - Interleukin-10	Systemic inflammation will be assessed by measuring concentrations of interleukin-10 (IL-10). Samples will be taken pre- and post-intervention to assess changes.	6 Months
Inflammation and Biomarkers in Serum - Interleukin-18	Systemic inflammation will be assessed by measuring concentrations of interleukin-18 (IL-18). Samples will be taken pre- and post-intervention to assess changes.	6 Months
Inflammation and Biomarkers in Serum - Calprotectin	Systemic inflammation will be assessed by measuring concentrations of calprotectin. Samples will be taken pre- and post-intervention to assess changes.	6 Months
Inflammation and Biomarkers in Serum - cortisol	Systemic inflammation will be assessed by measuring concentrations of cortisol. Samples will be taken pre- and post-intervention to assess changes.	6 Months
Microbiome Diversity	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.	6 Months
Sleep Efficiency	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.	6 Months
Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index will be used to collect subjective sleep quality data on a monthly basis.	6 Months
Total Grey Matter Volume	Total grey matter volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.	6 Months
Hippocampal Volume	Hippocampal volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.	6 Months
White matter hyperintensities volume	White matter hyperintensities volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.	6 Months
Myelin Water	Myelin water imaging will be collected using resting state functional MRI. Testing is done pre- and post-intervention to compares scores.	6 Months
Functional MRI	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.	6 Months
Maximal oxygen consumption (VO2 Max)	Predicted maximal oxygen consumption will be measured using a six-minute walk test. Testing is done pre- and post-intervention to compares scores.	6 Months
Heart Rate Recovery	Heart rate recovery will be measured using a three-minute step test. Testing is done pre- and post-intervention to compares scores.	6 Months
Berg Balance Assessment	A Berg Balance Assessment will be used to measure participants balance. Testing is done pre- and post-intervention to compares scores.	6 Months
Dynamic Gate Index	The Dynamic Gait Index will be used to measure participants gait. Testing is done pre- and post-intervention to compares scores.	6 Months
Timed Up and Go Test	The Dynamic Gait Index will be used to measure participants gait. Testing is done pre- and post-intervention to compares scores.	6 Months
30 Second Sit to Stand Test	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.	6 Months
Dual-Energy X-Ray Absorptiometry (DEXA)	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.	6-Months
Physical Activity Levels	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.	6 Months
Heart Rate	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.	6 Months
Fried Frailty Index	Physical frailty will be assessed using the fried frailty index. Testing is done pre- and post-intervention to compares scores.	6 Months
Blood Pressure	Blood pressure will be measured pre- and post-intervention to compares scores.	6 Months
Weight	Weight will be measured pre- and post-intervention to compares scores.	6 Months
Framingham Risk Score	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.	6 Months
NIH Toolbox- Emotional Battery	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.	6 Months
World Health Organization (WHO) Quality of Life Questionnaire	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.	6 Months
Freiburg Mindfulness Inventory	Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.	6 Months
Mindful Attention Awareness Scale	Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.	6 Months
Multidimensional Assessment of Interoceptive Awareness	Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.	6 Months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: The Jack and Darlene Poole Foundation
• Investigators: Principal Investigator: Silke Appel-Cresswell, MD, FRCPC, University of British Colombia

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): January 5, 2028

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Microbiome; Mindfulness; Well-Being
• Additional Relevant MeSH Terms: Behavior; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Relaxation Therapy; Exercise; Diet; Meditation
• Other Study ID Numbers: H21-01750

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No