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

NCT ID: NCT05193175

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-29
• Study Completion Date: 2023-06-01

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.

Detailed Description

Study design A repeated measures, randomised cross over study design will be used. All data collection will take place at the Sport and Exercise Science Laboratories, University of Bedfordshire, Polhill Avenue, Bedford, UK. After a preliminary testing session, participants will complete three, 6-hour experimental conditions in a random order: 1) uninterrupted sitting; 2) sitting interrupted with standing breaks, and 3) sitting interrupted with light intensity stepping breaks. There will be a washout period of at least 72 hours between conditions, as previous research suggests that a single session of exercise can affect blood glucose levels for the following 48 hours (Mikines, et al., 1988). Participants will be randomised to order of condition using computer generated random numbers. This will assign them a trial order using block randomization with balanced block sizes. Participants will be blinded to the trial condition until they arrive on the day of their first and second experimental conditions.

Preliminary testing Patients will first attend a preliminary testing session where they will become accustomed to light intensity stepping on the spot to the beat of a metronome and use of the Borg RPE scale. This will ensure patients are familiar with an intensity that is equivalent to an RPE of 8-11 (very light to light) that will be used in the respective experimental condition. Participants will step to different metronome paces starting at a slow pace and building up gradually every 1-2 minutes until an RPE of 8-11 is found. This imitates the intensity recommended within the warm up of CR, as recommended by BACPR. Height (cm) and weight (kg) will also be measured using a stadiometer (Harpenden 98.602, Holtain Ltd., Crymych) and digital scales (Tanita BWB0800, Tanita Corp., Tokyo, Japan) respectively, to calculate body mass index (kg/m2).

Experimental Protocol Participants will be asked to refrain from any alcohol and caffeine for 24 hours prior to each visit, as well as avoid exercise for 72 hours and complete an overnight fast. This will be explained to them during the preliminary visit. To monitor this, they will be asked prior to participation per visit whether they have fasted/ when they last ate and drank.

Participants will be asked to perform an overnight fast for at least 10 hours before arrival and minimise active travel to the laboratory (e.g. use a car for travel). They will rest for 30 minutes to achieve a steady state before baseline blood pressure (two measures with 2 minutes rest between each and the average taken) and blood samples are taken. Baseline cardiac function measures (global strain, ejection fraction and systolic volume) will be measured using an echocardiogram scan, as well as an electrocardiogram (ECG) to ensure there are no electrical contraindications to the heart which would make the participant unsuitable to complete the study intervention including ST depression / elevation or any arrythmias. Baseline mood and wellbeing measures will then be assessed using questionnaires.

Following baseline measures, a standardised breakfast will be consumed (see meals section below) and participants will then commence the experimental condition. See Figure 1 for schematic of experimental conditions.

The three experimental conditions for this study are:

1. Uninterrupted sitting for 6 hours.

2. Sitting interrupted with 5 minutes of static standing every 30 minutes.

3. 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.

A lunch meal will be provided at 12:00 during each condition. During sitting periods, participants will be able to read books, magazines or newspapers and/or watch TV, DVDs or media streaming services. Participants will be transported to the toilets and food consumption areas using a wheelchair to ensure activity is minimised and standardised between conditions.

Standardised food and water intake Each meal will provide approximately 30% of estimated daily energy requirements. This will be calculated for each individual participant using a prediction equation based on individual's height, weight and gender. Breakfast will consist of bran flakes, whole milk, and a honey and granola bar and will consist of 54% carbohydrate, 34% fat and 12% protein. Lunch will consist of a chicken sandwich, salted crisps and jammie dodger biscuit (54% carbohydrate, 34% fat and 12% protein). The macronutrient composition of the meals are in general agreement with guidelines recommended for a balanced diet (Public Health England, 2016). Participants will be encouraged to consume their meal within 15 minutes. The time taken will be recorded in the first condition and this time will then be replicated in the latter two conditions. Water will be available for the participants ad libitum during their first experimental condition visit. This volume of intake will be recorded and the same amount provided in the following two conditions spread over the day.

Data collection Finger prick capillary whole blood samples will be collected at baseline, 30, 60, 120, 180, 210, 240, 300 and 360 minutes throughout the conditions to allow later analysis of glucose, triglycerides, HDL-C, and insulin. Blood samples will be taken after the hand is pre-warmed in warm water for approximately 5 minutes. Blood pressure and heart rate will be measured 5 minutes before each of the blood samples are taken. Cardiac function measures and mood and wellbeing will be measured at baseline and post-condition.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Prolonged sitting

Uninterrupted sitting for 6 hours.

Group Type: EXPERIMENTAL

Prolonged sitting

Intervention Type: 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

Sitting interrupted with standing

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

Group Type: EXPERIMENTAL

Prolonged sitting

Intervention Type: 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

Sitting interrupted with light stepping

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.

Group Type: EXPERIMENTAL

Prolonged sitting

Intervention Type: 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

Interventions

Prolonged sitting

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Sitting interrupted with standing; Sitting interrupted with light stepping

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bedfordshire

OTHER

Sponsor Role: lead

Responsible Party

Abbie C. Bell

PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joanna Richards, PhD

Role: STUDY_DIRECTOR

University of Bedfordshire

Abbie C Bell, MSc

Role: PRINCIPAL_INVESTIGATOR

Bedfordshire Hospitals NHS Foundation Trust

Locations

Cardiac Rehabilitation

Bedford, Bedfordshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Abbie C Bell, MSc

Role: CONTACT

abbie.bell@study.beds.ac.uk

07984545911

Joanna Richards, PhD

Role: CONTACT

jo.richards@beds.ac.uk

01234400400

Facility Contacts

Abbie Bell, MSc

Role: primary

abbie.bell@study.beds.ac.uk

07984545911

Joanna Richards, PhD

Role: backup

jo.richards@beds.ac.uk

01234 400400

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

265468

Identifier Type: -

Identifier Source: org_study_id