Clinical Trial 63527

Miami, FL 33186


Summary:

The Mindful Steps Research Study is a fully remote study that requires no in-person presence. The research study is a 15-month program that is free of charge and may involve attending online mind-body exercise classes for 12 months and wearing a Fitbit that is designed to encourage walking and physical activity. The online mind-body exercise classes will be online, live group-classes that occur at a set schedule: once a week for 6 weeks, twice a month for 34 weeks, and once a month for 12 weeks, totaling to 25 classes. We are currently recruiting for the group that begins classes around January.

If you agree to participate in the study, you will be randomly assigned to one of two groups. One group participates in the online mind-body exercise classes, has access to a website that has motivational and educational content on becoming more physically active, and wears a Fitbit with daily step goals. The other group does not. You do not get to pick which group you will be in.

Regardless of your group assignment, you will have five remote testing visits: one at the beginning of the research study, one at 3 months, one at 6 months, one at 12 months, and one at 15 months. The testing consists of some questionnaires-where you will answer various questions about your physical activity and current condition. The questionnaires will each take about 45 minutes. You may also be chosen for qualitative interviews at the 6 month and 12 month timepoints, which would take an additional 30 minutes for each interview.

You will be paid $50 for completing the 3 month, 6 month, and 12 month, and 15 month testing visits, for a total of $200 for participating. There should be no out-of-pocket costs for you for attending the online classes or using the Fitbit. You will also receive a Fitbit device which is yours to keep after you complete the study.


Qualified Participants Must:

• Have a clinical diagnosis of COPD and/or clinical diagnosis of HF syndrome (including either HFrEF or HFpEF)
• Be Age >40
• Be able to obtain medical clearance from provider to participate in an exercise program
• Have an active email account
• Have access to a computer device (desktop, laptop, tablet, or smartphone that supports the Fitbit app Apple iOS 14 or higher, Android 8 or higher)
• Willingness to complete study procedures and engage in randomization
• Be English speaking


Qualified Participants May Receive:

Up to $200, a Fitbit Inspire 3 device, and study swag. 


If you or someone you care for is interested in participating and lives within 50 miles of the location shown, please complete the form below and click 'Submit'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.