Effects of Breaking up Sitting Time on Cardiometabolic Risk Markers and Cardiac Function Post Myocardial Infarction

NCT05193175 | Unknown

• 1 other identifier: 265468
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular Disease (CVD) is one of the greatest causes of mortality and morbidity globally, particularly in middle to high income countries. In the UK alone, it was accountable for 124,641 deaths in 2017. Further to this, CVD contributes to a vast economic burden, costing the National Health Service (NHS) £19billion annually. This is mainly due to a significant number of hospital readmissions following a first cardiac event (198,000 per annum). Following a cardiac event, an individual is therefore recommended to reduce their risk factors, including lipid profile, smoking status and physical inactivity, to reduce their risk of a secondary event. In healthy individuals, regularly breaking up sitting time reduces cardiometabolic risk markers. The aim of this study is to therefore observe if this effect is replicated in the cardiac population and thus whether breaking up sitting time will reduce the risk of a secondary cardiac event. Potential participants will be required to meet an inclusion criteria to take part in the study: aged 50 years or above and had a myocardial infarction within the past three months at the time of recruitment to the study. Participants will be randomised to each condition: 1) uninterrupted sitting; 2) sitting with intermittent standing and 3) sitting with intermittent light physical activity (stepping to a metronome beat). A number of physiological markers will be measured before, during and after each condition and analysed to compare the effectiveness of each condition. All measurements will be taken at the University of Bedfordshire Sport and Exercise Science Laboratories.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (14)

• Posterior wall thickness

  Posterior wall thickness in cm

  4 months

• Interventricular septum

  Interventricular septum in cm

  4 months

• Left ventricular internal diameter

  Left ventricular internal diameter in cm

  4 months

• Aortic root

  Aortic root in cm

  4 months

• End volume

  End volume in cm

  4 months

• E wave

  E wave in ms

  4 months

• A wave

  A wave in ms

  4 months

• Relative wall thickness

  Relative wall thickness in cm

  4 months

• Left ventricular mass

  Left ventricular mass in g

  4 months

• E/A ratio

  E/A ratio

  4 months

• Deceleration time

  Deceleration time in ms

  4 months

• Isovolumetric relaxation time

  Isovolumetric relaxation time in ms

  4 months

• Ejection fraction

  Ejection fraction in %

  4 months

• Stroke volume

  Stroke volume in L

  4 months

Secondary Outcomes (9)

• Systolic Blood pressure

  4 months

• Diastolic Blood pressure

  4 months

• Postprandial triglycerides

  4 months

• Postprandial total cholesterol

  4 months

• Postprandial low density lipoprotein cholesterol

  4 months

Study Arms (3)

Prolonged sitting

EXPERIMENTAL

Uninterrupted sitting for 6 hours.

Behavioral: Prolonged sitting

Sitting interrupted with standing

EXPERIMENTAL

Sitting interrupted with 5 minutes of static standing every 30 minutes for 6 hours.

Behavioral: Prolonged sitting

Sitting interrupted with light stepping

EXPERIMENTAL

Sitting interrupted with 5 minutes of light intensity stepping every 30 minutes using a metronome at the intensity determined during preliminary testing. This replicates active recovery time currently performed in a phase III CR class.

Behavioral: Prolonged sitting

Interventions

Prolonged sitting BEHAVIORAL

Cross over design, where participants will take part in all three interventions listed above: 1) uninterrupted sitting, 2) sitting interrupted with standing and 3) sitting interrupted with light stepping

Also known as: Sitting interrupted with standing, Sitting interrupted with light stepping

Prolonged sitting; Sitting interrupted with light stepping; Sitting interrupted with standing

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients post myocardial infarction (ST wave elevated MI or Non-ST wave elevated MI) within the past three months (confirmed by elevated blood biomarkers or electrocardiographic changes), in which the procedure/ recovery uncomplicated and are therefore classified as low risk.
• Aged 40 years or above.
• Any ethnicity.
• Individuals with diet controlled type 2 diabetes mellitus

You may not qualify if:

• Previous MI
• Under 40 years of age.
• Unable to provide valid informed consent (lack of mental capacity).
• Not had a cardiac event diagnosed within the past three months.
• Existing comorbidities including cancer, chronic kidney disease and gastro-oesophageal diseases.
• Unstable coronary disease.
• Diagnosed diabetes and use of medication.
• Disease or conditions with a prognosis of less than 6 months to end of life (palliative care). Any known blood borne disease.
• Unable to stand and engage in light-intensity stepping.

Sponsors & Collaborators

• University of Bedfordshire: lead

Study Sites (1)

Cardiac Rehabilitation

Bedford, Bedfordshire, MK429DJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Standing Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joanna Richards, PhD

  University of Bedfordshire

  STUDY DIRECTOR

• Abbie C Bell, MSc

  Bedfordshire Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abbie C Bell, MSc

CONTACT

07984545911; abbie.bell@study.beds.ac.uk

Joanna Richards, PhD

CONTACT

01234400400; jo.richards@beds.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 14, 2022
• Study Start: November 29, 2021
• Primary Completion: April 30, 2023
• Study Completion: June 1, 2023
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)