The BREAK UP study
Research type
Research Study
Full title
Efficacy of a personalised activity plan for BREAKing UP sitting time in patients with peripheral arterial disease and intermittent claudication (The BREAK UP study)
IRAS ID
280355
Contact name
T Yates
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
0 years, 11 months, 22 days
Research summary
Summary of Research
Intermittent claudication (IC) 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 IC, 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 with short bouts of physical activity, will improve physical function in patients with IC. A suite of multi-modal activities will be available which will inform a personalised activity plan for each participant.
Patients will be screened during their routine clinic appointment at Glenfield Hospital. All other study activity will take place remotely. Participants will be contacted a minimum of 11 times during your participation to discuss their progress and activity levels. We will collect information on their habitual physical activity, ability to complete physical tasks such as your walking ability, quality of life, breathlessness, anxiety and depression, and fatigue before and after the 8 week activity program. Participants will be expected to wear activity monitors for the duration of the 8-week intervention to measure steps, as well as two periods of 8 days to measure habitual physical activity levels.
Summary of Results
The aim of this study was to prove the concept of an 8-week personalised activity plan, using short periods of physical activity to break up sitting time in people with PAD and IC, to improve walking ability, and reduce time spent sitting. An 8 week personalised activity plan to break up sitting time significantly improves walking ability and reduces daily time spent sitting. There is also some evidence to support significant improvements in total time spent, and bouts of, prolonged sitting ≥60 minutes, total time spent standing, anxiety, depression, and activity according to the vascular quality of life questionnaire.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0251
Date of REC Opinion
16 Nov 2020
REC opinion
Further Information Favourable Opinion