RecruitingPhase 2NCT07443293

IMPACT 360 for Parkinson's Disease

IMPACT 360 Study for Parkinson's Disease


Sponsor

University of British Columbia

Enrollment

60 participants

Start Date

Oct 28, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study (IMPACT 360) is testing a comprehensive lifestyle intervention — combining exercise, mindfulness, and diet guidance — for people with early-stage Parkinson's disease or REM sleep behavior disorder (a sleep condition that can be an early sign of Parkinson's). The program is delivered using fitness trackers, video calls, and smartphone apps. **You may be eligible if...** - You are between 40 and 85 years old - You have been diagnosed with Parkinson's disease (early stage: Hoehn and Yahr 1 or 2) OR REM sleep behavior disorder confirmed by a sleep study - You are able to follow instructions and fill out questionnaires - You have access to a smartphone (for a Fitbit) and a laptop or tablet (for video calls) **You may NOT be eligible if...** - You have a chronic medical condition preventing exercise - You have significant cognitive impairment, severe depression, or an eating disorder - Your cognitive test score is below 21/30 on a standard memory test - You have MRI contraindications (metal implants, pacemaker, etc.) - You are already doing 3+ hours per week of moderate-vigorous exercise AND have completed mindfulness training or score high on the MIND diet questionnaire - You are pregnant, breastfeeding, or have a history of drug/alcohol abuse - You have an active bacterial/viral infection, GI cancer, or inflammatory bowel disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALExercise

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.

BEHAVIORALMeditation

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.

BEHAVIORALDiet

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


Locations(1)

University of British Colombia

Vancouver, British Columbia, Canada

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NCT07443293


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