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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Behavioral: Activity plan to break up sitting time

Detailed Description

Due to COVID-19 restrictions, the BREAK UP study is being conducted as an 8-week home-based before and after intervention study with the aim to improve physical function measured via the WIQ; and to reduce sitting time by up to 60 minutes per day, seven days a week.

Participants will be required to make contact with members of the research team twice to complete assessments remotely, once to complete a coaching consultation, and once per week during the 8-week activity plan to discuss their performance. Organisation of these, and any contact associated with recruitment may require more frequent contact with the research team via telephone or email.

Contact 1 (Recruitment/ eligibility):

Expression of interest to participate will be sought by the treating clinician at Glenfield hospital (listed on the delegation log), who will offer the patient a Participant Information Sheet, contact details form to complete and a consent form. The patient may then be approached by a member of the research team to take their consent, having read the information sheet, or if the participant is happy to be, a member of the research team will contact them within two weeks via telephone and/or email the participant to discuss the study in more detail and determine if they wish to participate or not. After which, they will be asked to complete the consent form and post this back to the research team. Once the signed and dated consent forms have been received, the researcher can organise for the baseline data to be collected.

Contact 2 (Baseline assessments):

Within 2 weeks participants will be required to complete baseline assessments which includes information on their date of birth/age, sex, ethnicity, smoking status, alcohol consumption, medical history (co-morbidities) and a number of questionnaires to assess their quality of life, breathlessness, anxiety and depression, fatigue and physical function. These will be completed over the telephone with the researcher or the researcher will post the questionnaires to the participants which will need to be completed and returned by post. These assessments will take approximately 1 hour.

Participants will also be posted two activity monitors (monitor 1 and 2) one of which will be wrist worn and the other thigh worn, as well as information on how to fit these. Participants will wear these for a period of up to 8 days to collect habitual physical activity data. A daily sleep-wake log will be used to collect data on participants sleep and wake-time, which will be posted, along with instructions on how to complete these, and returned via post along with the activity monitors.

Contact 3 (Coaching consultation):

Within 2 weeks participants will receive a telephone or video call which will be termed a "coaching consult", during which fourteen 2-minute activities to break sitting time will be discussed with a member of the research team. Video tutorials and/or instruction cards of these activities will be sent via post prior to the coaching consult. These activities and data from the habitual physical activity measure will be used to inform personalised activity plans whereby participants will be encouraged, using Bandura's social cognitive theory, to use these activities to reduce sitting time by up to 60 minutes per day for 8-weeks. This contact will take approximately 15 minutes. The 8-week activity plan will be prescribed, to complete at home and will begin within 2 weeks of this contact.

Participants will wear a wrist-worn activity monitor for the duration of the home-based 8-week intervention (monitor 3). They will be instructed on how to use these during the coaching consultation and how to complete daily diaries for monitor wear and activity completion for the 8-week period.

During the 8-week intervention participants will be contacted once a week via telephone or video to discuss their performance on the activity plan and completion of the daily diary. This will take approximately 15 minutes a week. A member of the research team will organise this over email or telephone.

A second 8-day habitual physical activity measurement period will take place during week 8 of the intervention. Activity monitors 1 and 2 will be posted to participants in good time along with instructions on how to fit these. During this second habitual physical activity measurement period participants will continue to wear wrist-worn activity monitor 3 as well.

Contact 4 (Follow-up):

Participants will then be contacted for their final assessments within one week of the end of the 8-week intervention. The follow-up assessments will include the same assessments as at baseline, except for one questionnaire, and will be completed via telephone with a member of the research team, or a researcher will be post these out to the participant for completion. The assessments will take approximately 1 hour.

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom, LE3 9QP
    • Recruiting
    • J Perks
    • Contact: J Perks; Phone Number: 01162583669; Email: jp549@le.ac.uk
    • Contact: Email: jp549@le.ac.uk
    • Principal Investigator: Rob Sayers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate overall changes in time spent performing physical activity	Measured using accelerometers (comparison of time spent performing physical activity at baseline vs. follow up assessed via mean acceleration mg/day )	8 weeks
To investigate overall changes in time spent in light physical activity	Measured using accelerometers (comparison of time spent in light physical activity at baseline vs. follow up assessed via acceleration mins/day)	8 weeks
To investigate overall changes in time spent in moderate physical activity	Measured using accelerometers (comparison of time spent in moderate physical activity at baseline vs. follow up assessed via acceleration mins/day)	8 weeks
To investigate overall changes in time spent in vigorous physical activity	Measured using accelerometers (comparison of time spent in vigorous physical activity at baseline vs. follow up assessed via acceleration mins/day)	8 weeks
To investigate overall changes in time spent in prolonged sitting	Measured using accelerometers (comparison of time spent sitting at baseline vs. follow-up assessed via acceleration)	8 weeks
To investigate overall changes in time spent in sleep	Measured using accelerometers (comparison of time spent sleeping at baseline vs. follow-up assessed via acceleration)	8 weeks
To investigate whether personalised activity breaks in sitting time improve quality of life	Measured using the Vascular Quality of Life (VascuQoL) questionnaire	8 weeks
To investigate whether personalised activity breaks in sitting time improve quality of life	Measured using the Euro Quality of Life (EQ-5D-5L) questionnaire	8 weeks
To investigate whether personalised activity breaks in sitting time improve breathlessness	Measured using the modified medical research council (mMRC) dyspnoea scale	8 weeks
To investigate whether personalised activity breaks in sitting time improve fatigue	Measured using Chalder's Fatigue Scale	8 weeks
To investigate whether personalised activity breaks in sitting time improve anxiety and depression	Measured using the hospital anxiety and depression scale	8 weeks

Collaborators and Investigators

• Sponsor: University of Leicester

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; exercise; intermittent claudication; sedentary time; prolonged sitting
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: 0795

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Once we have analysed the results, we will present our findings at scientific meetings and publish in medical research journals. All these results will be anonymous, and it would not be possible to identify participants.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No