Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:57 AM
Study NCT ID:
NCT07443293
Status:
RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMPACT 360 for Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020187', 'term': 'REM Sleep Behavior Disorder'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020923', 'term': 'REM Sleep Parasomnias'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D019122', 'term': 'Meditation'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': "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."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-24', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognition - NIH Toolbox Cognitive Battery', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'Cognition- Montreal Cognitive Assessment', 'timeFrame': '6 Months', 'description': 'Cognition will be measured using the Montreal Cognitive Assessment (MoCA). Testing is done pre- and post-intervention to compare scores.'}, {'measure': "Cognition- Parkinson's Disease Cognitive Rating Scale [Time Frame: 6 Months]", 'timeFrame': '6 Months', 'description': "Cognition will be measured using the Parkinson's Disease Cognitive Rating Scale (PD-CRS). Testing is done pre- and post-intervention to compare scores."}, {'measure': 'Inflammation and Biomarkers in Serum- High Sensitivity C-Reactive Protein', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'Inflammation and Biomarkers in Serum - Interleukin-1β', 'timeFrame': '6 Months', 'description': 'Systemic inflammation will be assessed by measuring concentrations of interleukin-1β (IL-1β). Samples will be taken pre- and post-intervention to assess changes.'}, {'measure': 'Inflammation and Biomarkers in Serum - Interleukin-6', 'timeFrame': '6 Months', 'description': 'Systemic inflammation will be assessed by measuring concentrations of interleukin-6 (IL-6). Samples will be taken pre- and post-intervention to assess changes.'}, {'measure': 'Inflammation and Biomarkers in Serum - Tumour Necrosis Factor Alpha', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'Inflammation and Biomarkers in Serum - Interleukin-8', 'timeFrame': '6 Months', 'description': 'Systemic inflammation will be assessed by measuring concentrations of interleukin-8 (IL-8). Samples will be taken pre- and post-intervention to assess changes.'}, {'measure': 'Inflammation and Biomarkers in Serum - Interleukin-10', 'timeFrame': '6 Months', 'description': 'Systemic inflammation will be assessed by measuring concentrations of interleukin-10 (IL-10). Samples will be taken pre- and post-intervention to assess changes.'}, {'measure': 'Inflammation and Biomarkers in Serum - Interleukin-18', 'timeFrame': '6 Months', 'description': 'Systemic inflammation will be assessed by measuring concentrations of interleukin-18 (IL-18). Samples will be taken pre- and post-intervention to assess changes.'}, {'measure': 'Inflammation and Biomarkers in Serum - Calprotectin', 'timeFrame': '6 Months', 'description': 'Systemic inflammation will be assessed by measuring concentrations of calprotectin. Samples will be taken pre- and post-intervention to assess changes.'}, {'measure': 'Inflammation and Biomarkers in Serum - cortisol', 'timeFrame': '6 Months', 'description': 'Systemic inflammation will be assessed by measuring concentrations of cortisol. Samples will be taken pre- and post-intervention to assess changes.'}, {'measure': 'Microbiome Diversity', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'Sleep Efficiency', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '6 Months', 'description': 'The Pittsburgh Sleep Quality Index will be used to collect subjective sleep quality data on a monthly basis.'}, {'measure': 'Total Grey Matter Volume', 'timeFrame': '6 Months', 'description': 'Total grey matter volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.'}, {'measure': 'Hippocampal Volume', 'timeFrame': '6 Months', 'description': 'Hippocampal volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.'}, {'measure': 'White matter hyperintensities volume', 'timeFrame': '6 Months', 'description': 'White matter hyperintensities volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.'}, {'measure': 'Myelin Water', 'timeFrame': '6 Months', 'description': 'Myelin water imaging will be collected using resting state functional MRI. Testing is done pre- and post-intervention to compares scores.'}, {'measure': 'Functional MRI', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'Maximal oxygen consumption (VO2 Max)', 'timeFrame': '6 Months', 'description': 'Predicted maximal oxygen consumption will be measured using a six-minute walk test. Testing is done pre- and post-intervention to compares scores.'}, {'measure': 'Heart Rate Recovery', 'timeFrame': '6 Months', 'description': 'Heart rate recovery will be measured using a three-minute step test. Testing is done pre- and post-intervention to compares scores.'}, {'measure': 'Berg Balance Assessment', 'timeFrame': '6 Months', 'description': 'A Berg Balance Assessment will be used to measure participants balance. Testing is done pre- and post-intervention to compares scores.'}, {'measure': 'Dynamic Gait Index', 'timeFrame': '6 Months', 'description': 'The Dynamic Gait Index will be used to measure participants gait. Testing is done pre- and post-intervention to compares scores.'}, {'measure': 'Timed Up and Go Test', 'timeFrame': '6 Months', 'description': 'The Dynamic Gait Index will be used to measure participants gait. Testing is done pre- and post-intervention to compares scores.'}, {'measure': '30 Second Sit to Stand Test', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'Dual-Energy X-Ray Absorptiometry (DEXA)', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'Physical Activity Levels', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'Heart Rate', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'Fried Frailty Index', 'timeFrame': '6 Months', 'description': 'Physical frailty will be assessed using the fried frailty index. Testing is done pre- and post-intervention to compares scores.'}, {'measure': 'Blood Pressure', 'timeFrame': '6 Months', 'description': 'Blood pressure will be measured pre- and post-intervention to compares scores.'}, {'measure': 'Weight', 'timeFrame': '6 Months', 'description': 'Weight will be measured pre- and post-intervention to compares scores.'}, {'measure': 'Framingham Risk Score', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'NIH Toolbox- Emotional Battery', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'World Health Organization (WHO) Quality of Life Questionnai', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'Freiburg Mindfulness Inventory', 'timeFrame': '6 Months', 'description': 'Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.'}, {'measure': 'Mindful Attention Awareness Scale', 'timeFrame': '6 Months', 'description': 'Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.'}, {'measure': 'Multidimensional Assessment of Interoceptive Awareness', 'timeFrame': '6 Months', 'description': 'Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.'}, {'measure': 'Motor and Non-motor Complications and Experiences of Daily Living', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'Glucose Metabolism', 'timeFrame': '6 Months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Mindfulness', 'Nutrition', 'Microbiome', 'Well-Being'], 'conditions': ["Parkinson's Disease (PD)", 'REM Sleep Behavior Disorder']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nRisk 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40-85 years\n* A diagnosis of either PD, based on the Movement Disorder Society (MDS) criteria, OR, RBD, through a polysomnography\n* Hoehn \\& Yahr score of 1 to 2\n* Able to fill out questionnaires\n* Able to follow instructions and directions as required by the intervention.\n* Have access to the necessary technologies (i.e., a working smartphone for Fitbit, a laptop or tablet for Zoom) as required by the intervention.\n\nExclusion Criteria:\n\n* Any chronic medical condition which would affect ability to participate in exercise\n* Any contraindication for exercise based on the Physical Activity Readiness for Everyone Questionnaire (PAR-Q+) and medical clearance form\n* Significant cognitive impairment, depression, or eating disorder\n* Score \\<21/30 on the Montreal Cognitive Assessment (MoCA)\n* Any contraindication to MRI scanning; such as implanted metal clips or wires (see list below)\n* Participants who were told by a medical doctor that they need to be medically supervised for exercise\n* Participants currently doing 180 minutes or more of moderate-vigorous intensity exercise per week AND either of the following:\n\nCompletion of a Mindfulness-Based Stress Reduction course OR; Score \\>8/15 in the MIND Diet Questionnaire\n\n* Significant or unstable cardiovascular or respiratory disease\n* Severe/multiple head trauma(s)\n* Subjects who are pregnant or breastfeeding\n* Subjects with a history or major episodes of drug or alcohol abuse\n* Chronic/acute bacterial/viral infection\n* GI cancer\n* Inflammatory bowel disease\n\nExclusion for MRI scanning:\n\n* Individuals weighing \\> 400 lbs (limit of MRI machine)\n* Artificial heart valve\n* Brain aneurysm clip\n* Electrical stimulator for nerves or bones\n* Ear or eye implant\n* Implanted drug infusion pump\n* Coil, catheter, or filter in any blood vessel\n* Orthopedic hardware (artificial joint, plate, screws)\n* Other metallic prostheses\n* Shrapnel, bullets, or other metal fragments\n* Surgery or tattoos (including tattooed eyeliner) in the last six weeks\n* Brain surgery\n* Have a cardiac pacemaker, wires or defibrillator\n* Have had an injury where a piece of metal lodged in the eye or orbit\n* Have a ferromagnetic aneurysm clip'}, 'identificationModule': {'nctId': 'NCT07443293', 'briefTitle': "IMPACT 360 for Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': "IMPACT 360 Study for Parkinson's Disease", 'orgStudyIdInfo': {'id': 'H23-01709'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise, Diet, Mindfulness', 'description': 'The intervention group will start the intervention immediately following their baseline assessment. They will undergo another assessment after the 6 month intervention period.\n\nInterventions:\n\nBehavioural: Exercise Behavioural: Meditation Behavioural: Diet', 'interventionNames': ['Behavioral: Exercise', 'Behavioral: Meditation', 'Behavioral: Diet']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Group', 'description': '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.'}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Exercise, Diet, Mindfulness']}, {'name': 'Meditation', 'type': 'BEHAVIORAL', 'description': 'The intervention will involve 15 minute guided mediation following exercise classes as well as mindfulness classes.\n\nMindfulness 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.', 'armGroupLabels': ['Exercise, Diet, Mindfulness']}, {'name': 'Diet', 'type': 'BEHAVIORAL', 'description': 'The intervention will involve biweekly 1-hour nutrition and cooking classes with a dietician.', 'armGroupLabels': ['Exercise, Diet, Mindfulness']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6T 1Z3', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jeffrey Kelly', 'role': 'CONTACT', 'email': 'jeff.kelly@ubc.ca', 'phone': '604-827-4230'}, {'name': 'Annie Kuan', 'role': 'CONTACT', 'email': 'annie.kuan@ubc.ca', 'phone': '604-827-0576'}, {'name': 'Silke Appel-Cresswell', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of British Colombia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Jeffrey Kelly', 'role': 'CONTACT', 'email': 'jeff.kelly@ubc.ca', 'phone': '604-827-4230'}, {'name': 'Annie Kuan', 'role': 'CONTACT', 'email': 'annie.kuan@ubc.ca', 'phone': '604-827-0576'}], 'overallOfficials': [{'name': 'Silke Appel-Cresswell, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Colombia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Silke Cresswell', 'investigatorAffiliation': 'University of British Columbia'}}}}