Personalised Activity Plan for BREAKing UP Sitting Time in Patients With Peripheral Arterial Dise… (NCT04572737) | Clinical Trial Compass
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Personalised Activity Plan for BREAKing UP Sitting Time in Patients With Peripheral Arterial Disease and Intermittent Claudication (The BREAK UP Study)
United Kingdom35 participantsStarted 2021-03-31
Plain-language summary
Intermittent claudication is the most common manifestation of peripheral arterial disease, a common cardiovascular disease that causes blocked blood vessels (arteries) in the leg. Symptoms consist of persistent pain in one or both legs during exercise that is relieved with rest. Evidence suggests that high levels of uninterrupted sitting and sedentary behaviour are associated with cardiovascular disease risk, mortality and all-cause mortality. One of the main goals for treating people with intermittent claudication, is increased participation in physical activity. Supervised Exercise Programmes are recommended however these are not well tolerated and compliance is low. Alternative exercise, including short bouts of physical activity to break up sedentary time, has been suggested to help improve physical function.
This study will investigate whether alternative exercise, in the form of breaking up prolonged sitting time, will improve physical function in patients with intermittent claudication.
Patients will be screened during their routine clinic appointment at Glenfield Hospital. All other study activity will take place at the patients home.
Activity monitors will be worn for up to 8 days at baseline and follow-up, measuring step count and time, inactivity, activity time and intensity, and sleep duration. Participants will also be expected to wear activity monitors for the duration of the 8-week intervention to measure steps. Participants will be in the study for up to 18 weeks in total.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women
* Age ≥18 years
* ABPI \<0.9 or \>1.4 at rest OR \>20% decrease post exercise. When ABPI is \>0.9 but there is clinical suspicion of PAD, other non-invasive tests, which may include imaging, will be used to confirm diagnosis.
* History of intermittent claudication (exercise induced, aching/cramping, pain affecting the lower limbs or buttocks, which subsides with rest)
* Able and willing to give informed consent
* Able to speak, read, and write English
* Able to undertake light physical activity
Exclusion Criteria:
* Individuals with type 1, gestational, or monogenic diabetes mellitus
* On insulin therapy
* Hospital admission in preceding 3 months
* Current or planned pregnancy, or breast feeding
* Contra-indications to exercise
* Participation in CTIMP currently and/or in preceding 3 months
* Already participating in a structured SEP
* Serious illness with life-expectancy \< 1 year
* Previous major amputation
* Recent cardiovascular event (within the last 12 months)
* Comorbidity that the research team considered to be a contraindication to involvement in the study
* Unable to communicate in English
* Recent diagnosis or treatment for cancer (within 12 months)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.