Personalised Activity Plan for BREAKing UP Sitting Time in Patients With Peripheral Arterial Disease and Intermittent Claudication (The BREAK UP Study)

NCT04572737 | Unknown

• 1 other identifier: 0795
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

intermittent claudication; exercise; physical activity; prolonged sitting; sedentary time

Outcome Measures

Primary Outcomes (2)

• To investigate overall changes in sitting time

  Measured using accelerometers (comparison of time spent sitting at baseline vs. follow-up assessed via acceleration)

  8 weeks

• The walking impairment questionnaire

  Total score for 16 questions measuring walking distance, speed and stair climbing from 0 (worst/inability) to 4 (best/without limitations)

  8 weeks

Secondary Outcomes (11)

• To investigate overall changes in time spent performing physical activity

  8 weeks

• To investigate overall changes in time spent in light physical activity

  8 weeks

• To investigate overall changes in time spent in moderate physical activity

  8 weeks

• To investigate overall changes in time spent in vigorous physical activity

  8 weeks

• To investigate overall changes in time spent in prolonged sitting

  8 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

Participants will take part in an 8-week home-based activity plan to break up sitting time by 60 minutes per day.

Behavioral: Activity plan to break up sitting time

Interventions

Activity plan to break up sitting time BEHAVIORAL

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

J Perks

Leicester, LE3 9QP, United Kingdom

RECRUITING

Related Publications (1)

• Perks J, Mcbride P, Rayt H, Payne T, Edwardson C, Rowlands AV, Messeder SJ, Yates T, Sayers R. Efficacy of a personalised activity plan for BREAKing UP sitting time in patients with intermittent claudication (the BREAK UP study). Diabetes Res Clin Pract. 2023 Oct;204:110925. doi: 10.1016/j.diabres.2023.110925. Epub 2023 Sep 28.

  PMID: 37774979 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: before and after intervention study

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: October 1, 2020
• Study Start: March 31, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

GB (1)