Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04572737 |
| Other study ID # |
0795 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 31, 2021 |
| Est. completion date |
October 2022 |
Study information
| Verified date |
March 2022 |
| Source |
University of Leicester |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
