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.
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.
Diet: The intervention will involve biweekly 1-hour nutrition and cooking classes with a dietician.
Study summary
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.
Eligibility
Sex
ALL
Min age
40 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* Age 40-85 years
* A diagnosis of either PD, based on the Movement Disorder Society (MDS) criteria, OR, RBD, through a polysomnography
* Hoehn \& Yahr score of 1 to 2
* Able to fill out questionnaires
* Able to follow instructions and directions as required by the intervention.
* Have access to the necessary technologies (i.e., a working smartphone for Fitbit, a laptop or tablet for Zoom) as required by the intervention.
Exclusion Criteria:
* Any chronic medical condition which would affect ability to participate in exercise
* Any contraindication for exercise based on the Physical Activity Readiness for Everyone Questionnaire (PAR-Q+) and medical clearance form
* Significant cognitive impairment, depression, or eating disorder
* Score \<21/30 on the Montreal Cognitive Assessment (MoCA)
* Any contraindication to MRI scanning; such as implanted metal clips or wires (see list below)
* Participants who were told by a medical doctor that they need to be medically supervised for exercise
* Participants currently doing 180 minutes or more of moderate-vigorous intensity exercise per week AND either of the following:
Completion of a Mindfulness-Based Stress Reduction course OR; Score \>8/15 in the 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
Primary outcome measure(s)
Cognition - NIH Toolbox Cognitive Battery — 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.
Cognition- Montreal Cognitive Assessment — 6 Months Cognition will be measured using the Montreal Cognitive Assessment (MoCA). Testing is done pre- and post-intervention to compare scores.
Cognition- Parkinson's Disease Cognitive Rating Scale [Time Frame: 6 Months] — 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.
Inflammation and Biomarkers in Serum- High Sensitivity C-Reactive Protein — 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.
Inflammation and Biomarkers in Serum - Interleukin-1β — 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.
Inflammation and Biomarkers in Serum - Interleukin-6 — 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.
Inflammation and Biomarkers in Serum - Tumour Necrosis Factor Alpha — 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.
Inflammation and Biomarkers in Serum - Interleukin-8 — 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.
Inflammation and Biomarkers in Serum - Interleukin-10 — 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.
Inflammation and Biomarkers in Serum - Interleukin-18 — 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.
Inflammation and Biomarkers in Serum - Calprotectin — 6 Months Systemic inflammation will be assessed by measuring concentrations of calprotectin. Samples will be taken pre- and post-intervention to assess changes.
Inflammation and Biomarkers in Serum - cortisol — 6 Months Systemic inflammation will be assessed by measuring concentrations of cortisol. Samples will be taken pre- and post-intervention to assess changes.
Microbiome Diversity — 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.
Sleep Efficiency — 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.
Pittsburgh Sleep Quality Index — 6 Months The Pittsburgh Sleep Quality Index will be used to collect subjective sleep quality data on a monthly basis.
Total Grey Matter Volume — 6 Months Total grey matter volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.
Hippocampal Volume — 6 Months Hippocampal volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.
White matter hyperintensities volume — 6 Months White matter hyperintensities volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.
Myelin Water — 6 Months Myelin water imaging will be collected using resting state functional MRI. Testing is done pre- and post-intervention to compares scores.
Functional MRI — 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.
Maximal oxygen consumption (VO2 Max) — 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.
Heart Rate Recovery — 6 Months Heart rate recovery will be measured using a three-minute step test. Testing is done pre- and post-intervention to compares scores.
Berg Balance Assessment — 6 Months A Berg Balance Assessment will be used to measure participants balance. Testing is done pre- and post-intervention to compares scores.
Dynamic Gait Index — 6 Months The Dynamic Gait Index will be used to measure participants gait. Testing is done pre- and post-intervention to compares scores.
Timed Up and Go Test — 6 Months The Dynamic Gait Index will be used to measure participants gait. Testing is done pre- and post-intervention to compares scores.
30 Second Sit to Stand Test — 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.
Dual-Energy X-Ray Absorptiometry (DEXA) — 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.
Physical Activity Levels — 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.
Heart Rate — 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.
Fried Frailty Index — 6 Months Physical frailty will be assessed using the fried frailty index. Testing is done pre- and post-intervention to compares scores.
Blood Pressure — 6 Months Blood pressure will be measured pre- and post-intervention to compares scores.
Weight — 6 Months Weight will be measured pre- and post-intervention to compares scores.
Framingham Risk Score — 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.
NIH Toolbox- Emotional Battery — 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.
World Health Organization (WHO) Quality of Life Questionnai — 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.
Freiburg Mindfulness Inventory — 6 Months Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
Mindful Attention Awareness Scale — 6 Months Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
Multidimensional Assessment of Interoceptive Awareness — 6 Months Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
Motor and Non-motor Complications and Experiences of Daily Living — 6 Months 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.
Glucose Metabolism — 6 Months 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.
Trial sites (1)
Facility
City
Region
Status
University of British Colombia
Vancouver
British Columbia
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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