Cardiovascular DiseasesNCT05771610
SB and Cardiac Function and Structure in IHD
An observational study of Cardiovascular Diseases and Sedentary Behavior, run by University of Bedfordshire.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Sedentary Behavior
- What is being tested?
- Activity pattern in CVD
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 6 Mar 2023to 31 Dec 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: ischaemic heart disease, including a myocardial infarction within the past twelve months ((NSTEMI or STEMI) confirmed by blood markers or electrophysiological changes); or angina treated with PCI or CABG.
Who may be able to join
- · Patients diagnosed with ischemic heart disease within the past 12 months (within National Audit of Cardiac Rehabilitation (NACR) outcome data). This includes post myocardial infarction (ST wave elevated MI or Non-ST wave elevated MI), post coronary artery bypass graft, post percutaneous coronary intervention.
- Males and females
- Aged 18 years or above.
- Any ethnicity.
Who cannot join
- · Under 18 years of age.
- Unable to provide valid informed consent (lack of mental capacity).
- Not had a cardiac event diagnosed within the past 12 months.
- Unstable coronary disease.
- Disease or conditions with a prognosis of less than 6 months to end of life (palliative care).
About this study
Official title: Sedentary Time in Individuals With Ischaemic Heart Disease and Its Association With Cardiac Function, Structure and Cardiovascular Risk Factors
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.
Read the 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 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.
- Conditions
- Cardiovascular Diseases, Sedentary Behavior
- Being tested
- Activity pattern in CVD
- Medical subject headings
- Cardiovascular Diseases, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity pattern in CVDBehavioural
Only individuals who have had a cardiac event within the past twelve months upon recruitment will be included in this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily sitting time in IHD
Measured using activpal
Measured: 7 days
Secondary outcomes (20)
Posterior wall thickness
Measured in cm
Measured: 9 months
Intraventricular septum
Measured in cm
Measured: 9 months
Left ventricular internal diameter
Measured in cm
Measured: 9 months
Aortic root
Measured in cm
Measured: 9 months
End volume
Measured in cm
Measured: 9 months
E wave
measured in ms
Measured: 9 months
A wave
measured in ms
Measured: 9 months
Relative wall thickness
measured in cm
Measured: 9 months
Left ventricular mass
measured in cm
Measured: 9 months
E/A ratio
ratio between early and late diastolic filling
Measured: 9 months
Isovolumetric relaxation time
measured in ms
Measured: 9 months
Deceleration time
measured in ms
Measured: 9 months
Ejection fraction
presented as a percentage
Measured: 9 months
Stroke volume
measured in litres
Measured: 9 months
Systolic blood pressure
measured in mmHg
Measured: 9 months
Diastolic blood pressure
measured in mmHg
Measured: 9 months
Height
measured in cm
Measured: 9 months
Weight
measured in kg
Measured: 9 months
BMI
measured in kg/m2
Measured: 9 months
Hospital anxiety and depression score
Questions scored out of 3 to determine anxiety and depression level
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start6 Mar 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bedfordshire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbie C. Bell, University of Bedfordshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771610
- Sponsor's protocol ID
- SB and IHD
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedentary Time in Individuals With Ischaemic Heart Disease and Its Association With Cardiac Function, Structure and Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT05771610
- Acronym / sponsor ID
- SB and IHD
- Conditions
- Cardiovascular Diseases, Sedentary Behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- University of BedfordshireUniversity, hospital or other
- Study start
- 6 Mar 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Mar 2023 (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.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- ischaemic heart disease, including a myocardial infarction within the past twelve months ((NSTEMI or STEMI) confirmed by blood markers or electrophysiological changes); or angina treated with PCI or CABG.
Key inclusion criteria (4 listed)
- · Patients diagnosed with ischemic heart disease within the past 12 months (within National Audit of Cardiac Rehabilitation (NACR) outcome data). This includes post myocardial infarction (ST wave elevated MI or Non-ST wave elevated MI), post coronary artery bypass graft, post percutaneous coronary intervention.
Key exclusion criteria (5 listed)
- · Under 18 years of age.
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 pattern in CVDOnly individuals who have had a cardiac event within the past twelve months upon recruitment will be included in this study. | Behavioural | – |
Primary outcome
Daily sitting time in IHD
Time frame: 7 days
Measured using activpal
20 secondary outcomes
Posterior wall thickness
Time frame: 9 months
Intraventricular septum
Time frame: 9 months
Left ventricular internal diameter
Time frame: 9 months
Aortic root
Time frame: 9 months
End volume
Time frame: 9 months
E wave
Time frame: 9 months
A wave
Time frame: 9 months
Relative wall thickness
Time frame: 9 months
Left ventricular mass
Time frame: 9 months
E/A ratio
Time frame: 9 months
Isovolumetric relaxation time
Time frame: 9 months
Deceleration time
Time frame: 9 months
Ejection fraction
Time frame: 9 months
Stroke volume
Time frame: 9 months
Systolic blood pressure
Time frame: 9 months
Diastolic blood pressure
Time frame: 9 months
Height
Time frame: 9 months
Weight
Time frame: 9 months
BMI
Time frame: 9 months
Hospital anxiety and depression score
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Sedentary Behavior, run by University of Bedfordshire.
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 4 inclusion and 5 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 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily sitting time in IHD (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2023.