Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05771610 |
| Other study ID # |
SB and IHD |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 6, 2023 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
University of Bedfordshire |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Cardiovascular Disease (CVD) is the leading cause of mortality and morbidity globally.
Following a myocardial infarction (MI), an individual is at an increased risk of a secondary
event (20-50% higher risk post MI), compared to those with no prior CVD. Independent of
physical activity levels, high amounts of daily sitting is a risk factor for CVD, of which
sitting is typically used as an indicator for sedentary behaviour. Sedentary behaviour is
defined as a waking energy expenditure of less than 1.5 METs (metabolic task equivalent)
while in a seated, reclined or lying posture.
Currently, there is little knowledge regarding the prevalence of sedentary behaviour
ischaemic heart disease. The aim of this study is therefore to measure activity levels of an
individual following a diagnosis of ischaemic heart disease, alongside its association to
cardiac function and cardiovascular risk factors. Sitting patterns and physical activity will
be monitored 24 h/day during each condition using an activPAL activity monitor (PAL
Technologies, Glasco, Scotland). This will measure changes in posture and level of activity
by cadence.
Description:
An observational, cross-sectional study design will be used. Participants can have
preliminary measures taken either during a visit to the Sport and Exercise Sciences
Laboratories at the University of Bedfordshire or in their own home, depending on the
participant's preference. This consists of anthropometric measures (height, weight and waist
circumference). Participants will then rest for 5 minutes to achieve a steady state before
baseline blood pressure is taken. Baseline cardiac function measures will be measured using
an echocardiogram scan, as well as an electrocardiogram (ECG) to ensure there are no
electrical contraindications to the heart (including new ST depression / elevation or any
arrythmias) which would make the participant unsuitable to complete the study. Mood and
wellbeing measures will then be assessed using questionnaires.
Following this, participants will be asked to complete 7 full days of normal daily activity,
whilst wearing an activPAL monitor on their thigh to record sitting, standing and stepping.
The main data collection will take place at the participant's home, workplace or leisure
setting (i.e. under free-living conditions), with social distancing in place if required at
the time of data collection. Instructions will be given to help ensure that the 7-day
monitoring period reflects their usual habits. The monitoring period will also be carefully
decided, to ensure it does not conflict with any events that are out of the usual for the
participant, such as holidays or work-based events, which would alter their usual sedentary
patterns.
Data collection
Demographic data Patient demographic data will include age, gender, diagnosis and
intervention. This is routinely collected within Cardiac Rehabilitation as part of their
usual standard of care.
Height and weight Equipment to measure height, weight and waist circumference will include a
stadiometer (Leicester Height Scale, Marsden HM-250P, Leicester, UK) to measure height in cm,
a measurement tape for waist circumference and digital weighing scales (Tanita, BWB0800,
Allied Weighing, UK) to measure weight in kg.
Blood pressure and heart rate Blood pressure and heart rate will be measured in an upright,
seated position using an automated device (Omron M5-1 automated oscillatory device, Omron
Matsusaka Co. Ltd., Matsusaka, Japan). The left arm will be used to measure blood pressure
unless there is preference for the right arm due to any potential previous medical
conditions. Two measures will be taken, with 5 minutes apart.
Cardiac function In a laboratory or in the participants home, the participant will be asked
to undress from the waist up and lay on the medical couch in the left lateral decubitus
position. Here, a scanning gel will be applied to the echocardiogram probe. This forms part
of the echocardiogram system (Esoate, MyLab Omega, Italy). Parasternal and apical views will
be acquired. Once these images are collected and stored, the gel will be removed from the
probe and chest. All images will be stored anonymously, where participants will be given a
participant ID number. All image analysis will be completed using Echopac software (GE
Healthcare, Version 113, GE healthcare, Chicago, Illinois, United States). Measures taken
from the echocardiogram scan will be used to calculate left ventricular structure and
function.
Anxiety and Depression The Hospital Anxiety and Depression Scale will be used to assess
feelings of anxiety or depression.
Measurement of sitting, standing and light physical activity Following preliminary measures,
sitting, standing and stepping will be monitored 24 h/day over seven full days using an
activPAL activity monitor (PAL Technologies, Glasco, Scotland). This will measure changes in
posture and level of activity by cadence. The activity monitor will be attached to the skin
with a waterproof dressing on the anterior right thigh. standing. The Processing PAL
application will be used to process the data collected from the activPAL device. It uses a
vaildated algorithm to isolate waking and sleeping time and to generate the outcome data.
Participants will also be given a 7 day activity diary to record waking times, and other
relevant activities to cross-validate the Processing PAL measured sleep and wake times.
