IMPACT 360 for Parkinson's Disease

NCT07443293 | Recruiting Phase 2

• 1 other identifier: H23-01709
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease (PD); REM Sleep Behavior Disorder

Keywords

Exercise; Mindfulness; Nutrition; Microbiome; Well-Being

Outcome Measures

Primary Outcomes (40)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  6 Months

• Pittsburgh Sleep Quality Index

  The Pittsburgh Sleep Quality Index will be used to collect subjective sleep quality data on a monthly basis.

  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.

  6 Months

• Hippocampal Volume

  Hippocampal volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  6 Months

• Blood Pressure

  Blood pressure will be measured pre- and post-intervention to compares scores.

  6 Months

• Weight

  Weight will be measured pre- and post-intervention to compares scores.

  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.

  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.

  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.

  6 Months

• Freiburg Mindfulness Inventory

  Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.

  6 Months

• Mindful Attention Awareness Scale

  Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.

  6 Months

• Multidimensional Assessment of Interoceptive Awareness

  Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.

  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.

  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.

  6 Months

Study Arms (2)

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

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.

Interventions

Exercise BEHAVIORAL

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.

Exercise, Diet, Mindfulness

Meditation BEHAVIORAL

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.

Exercise, Diet, Mindfulness

Diet BEHAVIORAL

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

Exercise, Diet, Mindfulness

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Colombia

Vancouver, British Columbia, V6T 1Z3, Canada

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; REM Sleep Behavior Disorder; Motor Activity

Interventions

Exercise; Meditation; Diet

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Silke Appel-Cresswell, MD, FRCPC

  University of British Colombia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Kelly

CONTACT

604-827-4230; jeff.kelly@ubc.ca

Annie Kuan

CONTACT

604-827-0576; annie.kuan@ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: October 28, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)