Parkinson's Disease (PD)Phase 2NCT07443293
IMPACT 360 for Parkinson's Disease
A Phase 2 study testing Exercise, Meditation and Diet in people with Parkinson's Disease (PD) and REM Sleep Behavior Disorder, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson's Disease (PD), REM Sleep Behavior Disorder
- What is being tested?
- Exercise, Meditation and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 28 Oct 2024to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 30Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Colombia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: IMPACT 360 Study for Parkinson's Disease
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.
Read the detailed description
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.
- Being tested
- Exercise, Meditation, Diet
- Keywords
- Exercise, Mindfulness, Nutrition, Microbiome, Well-Being
- Medical subject headings
- Parkinson Disease, REM Sleep Behavior Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
MeditationBehavioural
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.
DietBehavioural
The intervention will involve biweekly 1-hour nutrition and cooking classes with a dietician.
| Study group | Role | What they receive |
|---|---|---|
| Exercise, Diet, Mindfulness | Experimental | The intervention group will start the intervention immediately following their baseline assessment. They will undergo another assessment after the 6 month intervention period.
Interventions:
Behavioural: Exercise Behavioural: Meditation Behavioural: Diet Receives: Behavioral: Exercise; Behavioral: Meditation; Behavioral: Diet |
| Waitlist Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Months
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index will be used to collect subjective sleep quality data on a monthly basis.
Measured: 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.
Measured: 6 Months
Hippocampal Volume
Hippocampal volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Months
Blood Pressure
Blood pressure will be measured pre- and post-intervention to compares scores.
Measured: 6 Months
Weight
Weight will be measured pre- and post-intervention to compares scores.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Months
Freiburg Mindfulness Inventory
Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
Measured: 6 Months
Mindful Attention Awareness Scale
Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
Measured: 6 Months
Multidimensional Assessment of Interoceptive Awareness
Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
Measured: 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.
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start28 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Adults 40-85 years of age with a diagnosis of Parkinson's disease (PD) or REM-sleep behaviour disorder (RBD) will be recruited and screened for eligibility. Sixty participants will be randomly assigned to the waitlist group or the intervention group and will be striated into cohorts blocks. Each cohort block will start the intervention at the same time and will participate in the intervention together. This will allow for social interaction, engagement with their peers, and hopefully encourage better adherence.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silke Cresswell, University of British Columbia
- Investigators
- Silke Appel-Cresswell, MD, FRCPC, Principal investigator, University of British Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443293
- Sponsor's protocol ID
- H23-01709
- Status last verified
- Jun 2026
- First submitted
- 24 Feb 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT 360 Study for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07443293
- Acronym / sponsor ID
- H23-01709
- Keywords
- Exercise, Mindfulness, Nutrition, Microbiome, Well-Being
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adults 40-85 years of age with a diagnosis of Parkinson's disease (PD) or REM-sleep behaviour disorder (RBD) will be recruited and screened for eligibility. Sixty participants will be randomly assigned to the waitlist group or the intervention group and will be striated into cohorts blocks. Each cohort block will start the intervention at the same time and will participate in the intervention together. This will allow for social interaction, engagement with their peers, and hopefully encourage better adherence.
| Arm | Type | Receives |
|---|---|---|
| Exercise, Diet, Mindfulness | Experimental | Behavioral: Exercise, Behavioral: Meditation, Behavioral: DietThe intervention group will start the intervention immediately following their baseline assessment. They will undergo another assessment after the 6 month intervention period. Interventions: Behavioural: Exercise Behavioural: Meditation Behavioural: Diet |
| Waitlist Group | No intervention | –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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (30 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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. | Behavioural | Exercise, Diet, Mindfulness |
| MeditationThe 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. | Behavioural | Exercise, Diet, Mindfulness |
| DietThe intervention will involve biweekly 1-hour nutrition and cooking classes with a dietician. | Behavioural | Exercise, Diet, Mindfulness |
Primary outcome
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.
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.
Cognition- Parkinson's Disease Cognitive Rating Scale [Time Frame: 6 Months]
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Hippocampal Volume
Time frame: 6 Months
Hippocampal volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.
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.
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.
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.
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.
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.
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.
Dynamic Gait 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.
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.
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.
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.
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.
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.
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.
Blood Pressure
Time frame: 6 Months
Blood pressure will be measured pre- and post-intervention to compares scores.
Weight
Time frame: 6 Months
Weight will be measured pre- and post-intervention to compares scores.
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.
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.
World Health Organization (WHO) Quality of Life Questionnai
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.
Freiburg Mindfulness Inventory
Time frame: 6 Months
Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
Mindful Attention Awareness Scale
Time frame: 6 Months
Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.
Multidimensional Assessment of Interoceptive Awareness
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silke Appel-Cresswell, MD, FRCPC principal investigator
University of British Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise, Meditation and Diet in people with Parkinson's Disease (PD) and REM Sleep Behavior Disorder, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition - NIH Toolbox Cognitive Battery (time frame: 6 Months). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.