ClinicalTrials.gg
Not yet recruitingNCT05771610Updated Mar 16, 2023

SB and Cardiac Function and Structure in IHD

An observational study in Cardiovascular Diseases and Sedentary Behavior, sponsored by University of Bedfordshire. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-16.

Sponsored by University of Bedfordshire · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
67
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Cardiovascular Diseases
  • Sedentary Behavior
03

In context

Cardiovascular Diseases

5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.

This study's planned enrollment of 67 is below the median of 506 across 1,572 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of Bedfordshire is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • 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.

Exclusion criteria

Exclusion Criteria:

    • Under 18 years of age.

      • Unable to provide valid (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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
67 participants (estimated)
Patient registry
No

Interventions

  • BehavioralActivity pattern in CVD

    Only individuals who have had a cardiac event within the past twelve months upon recruitment will be included in this study.

06

What researchers measure

Primary outcomes

  1. Daily sitting time in IHD

    Measured using activpal

    Time frame: 7 days

Secondary outcomes

  1. Posterior wall thickness

    Measured in cm

    Time frame: 9 months

  2. Intraventricular septum

    Measured in cm

    Time frame: 9 months

  3. Left ventricular internal diameter

    Measured in cm

    Time frame: 9 months

  4. Aortic root

    Measured in cm

    Time frame: 9 months

  5. End volume

    Measured in cm

    Time frame: 9 months

  6. E wave

    measured in ms

    Time frame: 9 months

  7. A wave

    measured in ms

    Time frame: 9 months

  8. Relative wall thickness

    measured in cm

    Time frame: 9 months

  9. Left ventricular mass

    measured in cm

    Time frame: 9 months

  10. E/A ratio

    ratio between early and late diastolic filling

    Time frame: 9 months

  11. Isovolumetric relaxation time

    measured in ms

    Time frame: 9 months

  12. Deceleration time

    measured in ms

    Time frame: 9 months

  13. Ejection fraction

    presented as a percentage

    Time frame: 9 months

  14. Stroke volume

    measured in litres

    Time frame: 9 months

  15. Systolic blood pressure

    measured in mmHg

    Time frame: 9 months

  16. Diastolic blood pressure

    measured in mmHg

    Time frame: 9 months

  17. Height

    measured in cm

    Time frame: 9 months

  18. Weight

    measured in kg

    Time frame: 9 months

  19. BMI

    measured in kg/m2

    Time frame: 9 months

  20. Hospital anxiety and depression score

    Questions scored out of 3 to determine anxiety and depression level

    Time frame: 9 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05771610
Lead sponsor
University of Bedfordshire
Responsible party
Abbie C. Bell (Principal Investigator, University of Bedfordshire) — Principal investigator
First posted
Mar 16, 2023
Start date
Mar 6, 2023 (estimated)
Primary completion
Dec 1, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Mar 16, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion