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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)

NCT04572737 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-03-14

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease

Interventions

BEHAVIORAL

Activity plan to break up sitting time

This research study aims to prove efficacy of a home-based physical activity intervention targeted at reducing periods of prolonged sitting and improving physical function in patients with intermittent claudication.

Sponsors & Collaborators

  • University of Leicester

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04572737 on ClinicalTrials.gov