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 40 to 85 with a current diagnosis Parkinson's disease 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.
Despite its rapidly rising prevalence and status as the second most common neurodegenerative disease worldwide, Parkinson's disease (PD) remains without pharmacological or neuroprotective therapies to prevent or slow down disease progression. While there is marked heterogeneity in its presentation, PD is diagnostically linked to motor impairments, including bradykinesia (slowness of movement), tremors, rigidity, dyskinesia (involuntary, erratic movement), and dystonia (involuntary muscle contraction causing slow, repetitive movement), as well as cognitive decline and neuroinflammation, negatively affecting activities of daily living. Additionally, PD may have a very long prodromal phase, which can last up to decades. During this period, individuals may develop non-motor symptoms, including REM-Sleep Behaviour Disorder (RBD), a nervous system disorder. Typically, during REM sleep, individuals experience a loss of muscle tone, which is absent from those with RBD. As such, RBD is generally characterized by a tendency to act out dreams. Due to the very high specificity for people with RBD to later develop PD26, the study of individuals with idiopathic RBD is particularly valuable, as pathology to the brain is limited at this time. Information about the early, premotor stages of PD can be gathered at a time when therapeutic interventions are most promising. Current research suggests that exercise, meditation, and nutrition have beneficial neuroprotective effects. Physical activity has been associated with improved learning and memory and cognitive function. Long-term exercise has also been shown to upregulate anti-inflammatory and neuroprotective factors. Research examining the effects of mindfulness interventions have found significant increases in grey matter and functional connectivity. Diets high in fruit and vegetable content and low in higher-inflammatory foods such as red meats and sweets, like the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet, have been shown to increase levels of plasma brain-derived neurotrophic factor. 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. Risk factors for many neurological conditions can be modified, indicating that some instances of neurological dysfunction can be prevented through lifestyle modifications. For example, potentially modifiable risk factors for dementia include: high blood pressure, Type 2 diabetes, obesity, lack of physical activity, hearing loss, and poor diet. Many of these can be improved through exercise and nutrition and there is evidence that this combined lifestyle intervention may also be beneficial for those already diagnosed with neurological conditions. A comprehensive examination evaluating health and wellness in people with Parkinson's disease (PwP) and people with RBD (PwRBD) will help us to understand the mechanisms behind the benefits of this combined intervention and how the interactive effects impact one's overall health. The aim of this study is to evaluate the effects of a multimodal intervention in PwP and PwRBD and to elucidate the mechanisms driving the associated changes. 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. Glucose metabolism will be evaluated as an optional 9th key area of health.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
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.
The intervention will involve biweekly 1-hour nutrition and cooking classes with a dietician.
University of British Colombia
Vancouver, British Columbia, Canada
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.
Time frame: 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.
Time frame: 6 Months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 Months
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index will be used to collect subjective sleep quality data on a monthly basis.
Time frame: 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.
Time frame: 6 Months
Hippocampal Volume
Hippocampal volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 Months
Dynamic Gait Index
The Dynamic Gait Index will be used to measure participants gait. Testing is done pre- and post-intervention to compares scores.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 Months
Blood Pressure
Blood pressure will be measured pre- and post-intervention to compares scores.
Time frame: 6 Months
Weight
Weight will be measured pre- and post-intervention to compares scores.
Time frame: 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.
Time frame: 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.
Time frame: 6 Months
World Health Organization (WHO) Quality of Life Questionnai
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.
Time frame: 6 Months
Freiburg Mindfulness Inventory
Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
Time frame: 6 Months
Mindful Attention Awareness Scale
Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
Time frame: 6 Months
Multidimensional Assessment of Interoceptive Awareness
Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
Time frame: 6 Months
Motor and Non-motor Complications and Experiences of Daily Living
Motor and non-motor complications and experiences of daily living will be measured using the MDS-UPDRS. Testing is done pre- and post-intervention to compare scores.
Time frame: 6 Months
Glucose Metabolism
Glucose metabolic patterns will be estimated by positron emission tomography (PET) using the radiotracer \[18F\]fluorodeoxyglucose. Testing is done pre- and post-intervention to compare patterns.
Time frame: 6 Months
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