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IMPACT 360 Study for Parkinson's Disease

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
University of British Colombia
RECRUITING
Vancouver
Contact Information
Primary
Jeffrey Kelly
jeff.kelly@ubc.ca
604-827-4230
Backup
Annie Kuan
annie.kuan@ubc.ca
604-827-0576
Time Frame
Start Date: 2024-10-28
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Exercise, Diet, Mindfulness
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
No_intervention: Waitlist Group
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.
Related Therapeutic Areas
Sponsors
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov