Impact 360 for Healthy Agers

Официальное название

Impact 360 Study for Healthy Agers

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Cognition - NIH Toolbox Cognitive Battery [Срок оценки: 6 Months]
• Cognition- Montreal Cognitive Assessment [Срок оценки: 6 Months]
• Cognition- Parkinson's Disease Cognitive Rating Scale [Срок оценки: 6 Months]
• Inflammation and Biomarkers in Serum- High Sensitivity C-Reactive Protein [Срок оценки: 6 Months]
• Inflammation and Biomarkers in Serum - Interleukin-1β [Срок оценки: 6 Months]
• Inflammation and Biomarkers in Serum - Interleukin-6 [Срок оценки: 6 Months]
• Inflammation and Biomarkers in Serum - Tumour Necrosis Factor Alpha [Срок оценки: 6 Months]
• Inflammation and Biomarkers in Serum - Interleukin-8 [Срок оценки: 6 Months]
• Inflammation and Biomarkers in Serum - Interleukin-10 [Срок оценки: 6 Months]
• Inflammation and Biomarkers in Serum - Interleukin-18 [Срок оценки: 6 Months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• University of British Colombia — Vancouver

Идентификаторы

NCT: NCT06516146 · H21-01750

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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