Diet, Exercise, and Meditation for Parkinson's Disease

Overseen By Jeffrey Kelly

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of British Columbia

Disqualifiers: Cognitive impairment, Depression, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Silke Appel-Cresswell, MD, FRCPC

Principal Investigator

University of British Colombia

Are You a Good Fit for This Trial?

Inclusion Criteria

Access to necessary technologies (e.g., working smartphone for Fitbit, laptop or tablet for Zoom) as required by the intervention

I am between 40 and 85 years old.

Ability to fill out questionnaires

Exclusion Criteria

Any chronic medical condition affecting ability to participate in exercise

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Group Treatment

Participants in the intervention group receive a 6-month multimodal intervention including exercise, mindfulness, and nutrition

6 months

Monthly assessments and continuous monitoring via wearable devices

Waitlist Group Observation

Participants in the waitlist group continue daily activities as usual for 6 months with monitoring

6 months

Monthly questionnaires and continuous monitoring via wearable devices

Waitlist Group Treatment

Participants in the waitlist group receive the 6-month multimodal intervention after the initial observation period

6 months

Monthly assessments and continuous monitoring via wearable devices

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IMPACT 360

How Is the Trial Designed?

Group I: Exercise, Diet, Mindfulness Experimental Treatment 3 Interventions

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

Group II: Waitlist Group Active Control 1 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 Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+