RecruitingPHASE2INTERVENTIONAL

IMPACT 360 for Parkinson's Disease

The IMPACT 360 study wants to see how a combination of exercise, mindfulness (like meditation), and good nutrition can help people with Parkinson's disease. Researchers will look at eight important health measures and try to understand how these lifestyle changes affect them. Sixty participants, aged 40 to 85, who have Parkinson's will take part. Everyone in the study will eventually receive the lifestyle program. Some will start right away after an initial check-up, while others will be in a 'waitlist' group, continuing their usual care for six months before starting the program. This helps researchers compare the effects accurately.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of British Columbia

Enrolment target

Start

28 Oct 2024

Estimated completion

31 Dec 2027

Parkinson's Disease (PD)REM Sleep Behavior Disorder

What is this study about?

Parkinson's disease is a condition that affects the brain and can cause problems with movement, like shaking, stiffness, and slow actions. It can also affect memory and thinking. While there's no cure yet, this study is exploring something called IMPACT 360, which combines exercise, mindfulness (a type of meditation), and healthy eating. The hope is that these lifestyle changes could help improve symptoms, protect the brain, and generally boost the health of people living with Parkinson's.

Researchers are particularly interested because current medicines don't fully stop or reverse the progression of Parkinson's. There's good reason to believe that being physically active, practicing mindfulness, and eating well can have positive effects on the brain and overall health. Some research suggests these things can improve memory, thinking, and even help reduce inflammation in the body. This study wants to confirm and understand these benefits better.

They're also looking at people who have a condition called REM Sleep Behavior Disorder (RBD), where people act out their dreams. This is important because many people with RBD later develop Parkinson's. Studying them early could give clues on how to help prevent or slow down Parkinson's before it causes severe problems. This study will carefully track how the combined approach of exercise, mindfulness, and nutrition affects various health markers in participants.

Key takeaways

It tests if exercise, mindfulness, and diet help Parkinson's.
Ages 40-85 with Parkinson's or specific sleep disorder (RBD) needed.
It's a 6-month program with a possible 6-month waitlist.
No new medications are involved, only lifestyle changes.
You'll need a smartphone and computer for participation.
There's a chance to improve health and contribute to understanding Parkinson's.

Who may be eligible?

To be considered for this study, you generally need to be between 40 and 85 years old. You should have a diagnosis of Parkinson's disease (confirmed by specific medical guidelines) or have been diagnosed with REM Sleep Behavior Disorder (RBD) through a sleep study. Your Parkinson's should be in the earlier stages, specifically a Hoehn & Yahr score of 1 or 2, which means you have mild symptoms that don't greatly affect your daily life.

You'll also need to be able to complete questionnaires and follow instructions for the program. Importantly, you'll need access to certain technology, like a smartphone for a fitness tracker and a computer or tablet for online sessions, as the program will involve these tools.

There are some reasons why you might not be able to participate. For example, if you have a medical condition that would make exercise unsafe, or if you have significant problems with your memory, mood, or eating. If you already exercise intensely for a long time each week, or regularly practice mindfulness, or strictly follow a very healthy diet like the MIND diet, you might not be eligible. Also, if you are pregnant or breastfeeding, have a history of serious drug or alcohol abuse, or have certain other significant health issues, you wouldn't be able to join. Finally, if you have any implanted metal in your body that would make an MRI scan unsafe, you also won't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 40 and 85 years old?
Do you have a confirmed diagnosis of Parkinson's or REM Sleep Behavior Disorder (RBD)?
Are you generally able to exercise and follow instructions?
Do you have a smartphone and access to a computer/tablet for online activities?
Do you have any metal implants that might make an MRI scan unsafe?
Do you have any serious health conditions that would make exercise dangerous?

Answer every question to see your result.

What does participation involve?

If you join the IMPACT 360 study, you'll first have an initial assessment. Then, you'll be placed into one of two groups. One group will start the 6-month program straight away. This program involves regular exercise, mindfulness activities, and guidance on healthy eating. You'll likely use a smartphone for activity tracking and a computer/tablet for online sessions.

The other group will be a 'waitlist' group. They will continue with their usual care for six months, meaning they won't start the special program during that time. After those six months, they will have another assessment, and then they will also receive the 6-month exercise, mindfulness, and nutrition program.

Throughout the study, regardless of your group, you'll have various assessments to see how your health is changing. These will likely include filling out questionnaires and could involve physical checks or even MRI scans for some participants. The total duration of your active involvement will be around 6 months if you start the program immediately, or around 12 months if you're in the waitlist group first.

Potential risks and benefits

Taking part in this study could offer several potential benefits, such as learning new ways to exercise, practice mindfulness, and eat healthy, which might improve your Parkinson's symptoms or overall well-being. However, there's no guarantee that you will personally benefit. As with any exercise program, there's a small risk of muscle soreness or minor injury, and MRI scans involve specific safety considerations. The study team will take precautions to ensure your safety. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of British Colombia
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is REM Sleep Behavior Disorder (RBD)?

RBD is a sleep condition where people physically act out their dreams, sometimes moving around quite a lot during sleep.

Why is this study looking at RBD?

Many people with RBD later develop Parkinson's disease, so researchers hope to learn how to help them earlier, before Parkinson's symptoms become more severe.

Will I have to take new medicine in this study?

No, this study focuses on lifestyle changes like exercise, mindfulness, and diet, not new medications.

What does a 'waitlist group' mean?

If you're in the waitlist group, you'll continue your usual care for six months before starting the special exercise and diet program, helping researchers compare results.

How long will I be involved in the study?

Your involvement in the main program lasts about 6 months, but if you're in the waitlist group first, it could be around 12 months in total.

How to find out more

Jeffrey Kelly

jeff.kelly@ubc.ca 604-827-4230 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.