Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05771610
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-16
First Post:
2023-03-02
Brief Title:
SB and Cardiac Function and Structure in IHD
Sponsor:
University of Bedfordshire
Organization:
University of Bedfordshire
Study Overview
Official Title:
Sedentary Time in Individuals With Ischaemic Heart Disease and Its Association With Cardiac Function Structure and Cardiovascular Risk Factors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 15 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 hday during each condition using an activPAL activity monitor PAL Technologies Glasco Scotland This will measure changes in posture and level of activity by cadence
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 hday during each condition using an activPAL activity monitor PAL Technologies Glasco Scotland This will measure changes in posture and level of activity by cadence
Detailed 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 participants 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 participants home workplace or leisure setting ie 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 hday 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
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 participants home workplace or leisure setting ie 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 hday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None