Peripheral Arterial DiseaseBREAK UPNCT04572737
Personalised Activity Plan for BREAKing UP Sitting Time in Patients With Peripheral Arterial Disease and Intermittent Claudication (The BREAK UP Study)
A study testing Activity plan to break up sitting time in people with Peripheral Arterial Disease, run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Activity plan to break up sitting time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Mar 2021to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
J Perks
Leicester, LE3 9QP
J Perks, 01162583669, jp549@le.ac.uk
jp549@le.ac.uk
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Activity plan to break up sitting time
- Keywords
- intermittent claudication, exercise, physical activity, prolonged sitting, sedentary time
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity plan to break up sitting timeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants will take part in an 8-week home-based activity plan to break up sitting time by 60 minutes per day. Receives: Behavioral: Activity plan to break up sitting time |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate overall changes in sitting time
Measured using accelerometers (comparison of time spent sitting at baseline vs. follow-up assessed via acceleration)
Measured: 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)
Measured: 8 weeks
Secondary outcomes (11)
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 )
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 8 weeks
To investigate whether personalised activity breaks in sitting time improve quality of life
Measured using the Vascular Quality of Life (VascuQoL) questionnaire
Measured: 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
Measured: 8 weeks
To investigate whether personalised activity breaks in sitting time improve breathlessness
Measured using the modified medical research council (mMRC) dyspnoea scale
Measured: 8 weeks
To investigate whether personalised activity breaks in sitting time improve fatigue
Measured using Chalder's Fatigue Scale
Measured: 8 weeks
To investigate whether personalised activity breaks in sitting time improve anxiety and depression
Measured using the hospital anxiety and depression scale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start31 Mar 2021
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- before and after intervention study
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572737
- Sponsor's protocol ID
- 0795
- Acronym
- BREAK UP
- Status last verified
- Mar 2022
- First submitted
- 14 Sep 2020
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37774979
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Activity Plan for BREAKing UP Sitting Time in Patients With Peripheral Arterial Disease and Intermittent Claudication (The BREAK UP Study)
- ClinicalTrials.gov ID
- NCT04572737
- Acronym / sponsor ID
- BREAK UP / 0795
- Conditions
- Peripheral Arterial Disease
- Keywords
- intermittent claudication, exercise, physical activity, prolonged sitting, sedentary time
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- before and after intervention study
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Activity plan to break up sitting timeParticipants will take part in an 8-week home-based activity plan to break up sitting time by 60 minutes per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity plan to break up sitting timeThis 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. | Behavioural | Experimental |
Primary outcome
To investigate overall changes in sitting time
Time frame: 8 weeks
Measured using accelerometers (comparison of time spent sitting at baseline vs. follow-up assessed via acceleration)
The walking impairment questionnaire
Time frame: 8 weeks
Total score for 16 questions measuring walking distance, speed and stair climbing from 0 (worst/inability) to 4 (best/without limitations)
11 secondary outcomes
To investigate overall changes in time spent performing physical activity
Time frame: 8 weeks
To investigate overall changes in time spent in light physical activity
Time frame: 8 weeks
To investigate overall changes in time spent in moderate physical activity
Time frame: 8 weeks
To investigate overall changes in time spent in vigorous physical activity
Time frame: 8 weeks
To investigate overall changes in time spent in prolonged sitting
Time frame: 8 weeks
To investigate overall changes in time spent in sleep
Time frame: 8 weeks
To investigate whether personalised activity breaks in sitting time improve quality of life
Time frame: 8 weeks
To investigate whether personalised activity breaks in sitting time improve quality of life
Time frame: 8 weeks
To investigate whether personalised activity breaks in sitting time improve breathlessness
Time frame: 8 weeks
To investigate whether personalised activity breaks in sitting time improve fatigue
Time frame: 8 weeks
To investigate whether personalised activity breaks in sitting time improve anxiety and depression
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Derived from this study: PubMed 37774979Perks 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity plan to break up sitting time in people with Peripheral Arterial Disease, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate overall changes in sitting time (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04572737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022; AzTrials last refreshed its copy on 1 Nov 2026.