Physical Activity Daily is a research study to help people who have peripheral artery disease (PAD) increase how much they can walk. Walking programs and rehabilitation may help decrease pain related to PAD and improve walking ability. We want to learn how a home-based walking program with telephone support compares to an Internet-based walking program. This website will tell you about our research study. It will help you figure out whether you are interested in being in our study. Here you can find out:
Who can be in this research study?
What would I do in this research study?
Does this research study involve any drugs or tests?
Will I get paid to be in this research study?
How do I see if I am eligible to participate in this research study?
If I am eligible and my doctor confirms it’s ok for me to participate, what happens next?
Who can I contact if I have questions or to learn more about this research study?
We are looking for people who currently have PAD. We are only looking for people who are 40 years or older. We are recruiting both men and women but women cannot be pregnant. To be in this study, you also have to have a computer, and an Internet connection -- but since you are already reading our website, you probably have those. You will need to have a doctor or healthcare provider who can sign a medical clearance form to make sure it is alright for you to be in this study.
This research study is looking to learn how an at-home walking program with weekly telephone support compares to an at-home Internet-based walking program. To see the difference, we will divide participants into 4 groups. We do this randomly, with a process much like flipping a coin. The 4 groups are:
- supervised PAD rehabilitation
- Internet-based walking program
- combination of both supervised PAD rehabilitation and the Internet-based walking program
If the coin toss puts you into group 1, you will receive weekly phone calls from us to help you stay on track with your walking program. You will also receive information and new skills to practice that will help you continue with your walking program.
If the coin toss puts you into group 2, you will be in the Internet-based walking program. You will get a pedometer that will count the steps you take every day. You will wear it for 12 months clipped to your belt or other piece of clothing, or tucked into your pocket. You will upload your pedometer regularly over the Internet.
We will email you a walking goal each week for 12 months based on your previous weeks' steps. You will have access to a personalized website where you can see your walking progress. You will also have access to an online community where you can post and read messages from other participants.
If the coin toss puts you into group 3, you will receive the phone calls and lessons as described above for group 1 and at the same time do the Internet-based walking program as described for group 2.
If the coin toss puts into group 4, you will continue your daily activities and health care as usual without anything added from us. At 12 months you will get a pedometer and access to the Internet-based walking program.
Click here to read the informed consent document to learn the specific details of this study. If you're interested in participating, we'll ask you to sign this document before you start. We'll go over this document with you at your first visit.
This study does not involve any drugs. If you decide to be in this study, you will do a treadmill walking test 3 times over 12 months. You will also do a 6-minute walk test 3 times over 12 months to see how far you can walk in 6 minutes. You will do these tests at baseline, 4 months and 12 months. We will measure things like height, weight, and heart rate. We will also measure the blood pressure in your arms and legs or toes.
You will complete some surveys 3 times during the study.
You will get a pedometer to keep. Groups 1 and 4 will get the pedometer after visit 3. Groups 2 and 3 will get the pedometer after their baseline visit. You will get a $40 after you complete the 4 month visit and you will get $100 after you complete the 12 month visit.
Please contact us to let us know you are interested. We will then call you to ask you some questions to see if you are eligible.
If you are eligible, you can download from our website a copy of the medical clearance form we need your doctor to sign. Or we can send the form to you.
We will contact you to schedule your first visit where we will review the informed consent document. If you agree to participate, you will sign the document and then you will begin the study.