Actively Recruiting

Phase 2
Age: 40Years - 85Years
All Genders
ID07443293

IMPACT 360 Study for Parkinson's Disease: Combined Exercise, Mindfulness, and Nutrition Intervention

Led by University of British Columbia · Updated on 2026-03-02

60

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a combined program of exercise, mindfulness, and nutrition on key health indicators in people aged 40 to 85 with Parkinson's disease or REM Sleep Behavior Disorder. This study aims to understand how these lifestyle changes affect brain health, cognition, inflammation, sleep, fitness, cardiovascular health, social and mental well-being, and microbiome diversity using a comprehensive "360 degree approach." The trial follows a partial crossover design where all participants eventually receive the intervention. The intervention includes online exercise classes three times a week for six months, guided meditation following exercise, mindfulness-based stress reduction classes, and biweekly nutrition and cooking sessions with a dietician. Participants are randomized to start the intervention immediately or after a six-month waitlist period during which they continue usual care. Physical activity and sleep are monitored using wearable devices throughout the study. Participants will complete assessments at baseline, after six months, and at the end of the intervention. Evaluations include cognitive tests, blood tests for inflammation markers, brain imaging, sleep quality assessments, physical fitness tests, cardiovascular measures, and questionnaires on mental and social health. Optional glucose metabolism testing is also offered. The study monitors adherence via wearable technology and questionnaires, with total participation lasting up to 12 months depending on group assignment.

CONDITIONS

Brief Title

IMPACT 360 for Parkinson's Disease

Who Can Participate

Age: 40Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 40 to 85 years
  • Diagnosis of Parkinson's disease based on Movement Disorder Society criteria or REM Sleep Behavior Disorder confirmed by polysomnography
  • Hoehn & Yahr score between 1 and 2
  • Ability to complete questionnaires
  • Ability to follow study instructions
  • Access to necessary technology such as a smartphone and laptop or tablet for online participation
Not Eligible

You will not qualify if you...

  • Any chronic medical condition preventing exercise participation
  • Contraindications for exercise based on PAR-Q+ and medical clearance
  • Significant cognitive impairment, depression, or eating disorder
  • Montreal Cognitive Assessment score below 21 out of 30
  • Contraindications to MRI scanning such as implanted metal devices or recent surgery
  • Medical advice requiring supervised exercise
  • Currently performing 180 minutes or more of moderate to vigorous exercise weekly and either completed mindfulness course or high MIND diet score
  • Significant or unstable cardiovascular or respiratory disease
  • Severe or multiple head traumas
  • Pregnancy or breastfeeding
  • History of major drug or alcohol abuse
  • Current bacterial or viral infection
  • Gastrointestinal cancer or inflammatory bowel disease
  • Weight over 400 pounds
  • Certain implants or metal fragments incompatible with MRI
  • Recent surgery or tattoos within six weeks
  • Brain surgery or pacemaker devices
  • Eye injuries involving metal fragments
  • Ferromagnetic aneurysm clips or other MRI contraindications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) for eligibility assessment

Baseline Assessment

Duration - 1 to 2 weeks

Participants undergo comprehensive baseline assessments covering cognition, inflammation, microbiome diversity, sleep quality, neurological imaging markers, physical fitness, cardiovascular health, and mental well-being.

1 visit (in-person)

Treatment

Duration - 6 months

Participants in the intervention group participate in a combined exercise, mindfulness, and nutrition program delivered online. Exercise classes occur three times weekly for 1 hour each. Mindfulness sessions include guided meditation after exercise classes and structured mindfulness classes varying in frequency and duration over 6 months. Nutrition classes with a dietician occur biweekly for 1 hour each.

Weekly online sessions consisting of 3 exercise classes with guided meditation, biweekly nutrition classes, and scheduled mindfulness classes

Post-Treatment Assessment

Duration - 2 to 4 weeks

Participants complete follow-up assessments identical to baseline to evaluate changes in key health areas after the intervention period.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

University of British Colombia

Vancouver, British Columbia, Canada, V6T 1Z3

Actively Recruiting

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Research Team

J

Jeffrey Kelly

A

Annie Kuan

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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