Cardiovascular DiseasesMOVE-MINCT05193175
Effects of Breaking up Sitting Time on Cardiometabolic Risk Markers and Cardiac Function Post Myocardial Infarction
A study testing Prolonged sitting in people with Cardiovascular Diseases, run by University of Bedfordshire at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Prolonged sitting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Nov 2021to 1 Jun 2023
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cardiac Rehabilitation
Bedford, Bedfordshire, MK429DJ
Abbie Bell, MSc, 07984545911, abbie.bell@study.beds.ac.uk
Joanna Richards, PhD, 01234 400400, jo.richards@beds.ac.uk
About this study
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.
Read more
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.
Read the 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:
- Uninterrupted sitting for 6 hours.
- Sitting interrupted with 5 minutes of static standing every 30 minutes.
- 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
- Being tested
- Prolonged sitting
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged sittingBehavioural
Also called Sitting interrupted with standing, Sitting interrupted with light stepping
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
| Study group | Role | What they receive |
|---|---|---|
| Prolonged sitting | Experimental | Uninterrupted sitting for 6 hours. Receives: Behavioral: Prolonged sitting |
| Sitting interrupted with standing | Experimental | Sitting interrupted with 5 minutes of static standing every 30 minutes for 6 hours. Receives: 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. Receives: Behavioral: Prolonged sitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterior wall thickness
Posterior wall thickness in cm
Measured: 4 months
Interventricular septum
Interventricular septum in cm
Measured: 4 months
Left ventricular internal diameter
Left ventricular internal diameter in cm
Measured: 4 months
Aortic root
Aortic root in cm
Measured: 4 months
End volume
End volume in cm
Measured: 4 months
E wave
E wave in ms
Measured: 4 months
A wave
A wave in ms
Measured: 4 months
Relative wall thickness
Relative wall thickness in cm
Measured: 4 months
Left ventricular mass
Left ventricular mass in g
Measured: 4 months
E/A ratio
E/A ratio
Measured: 4 months
Deceleration time
Deceleration time in ms
Measured: 4 months
Isovolumetric relaxation time
Isovolumetric relaxation time in ms
Measured: 4 months
Ejection fraction
Ejection fraction in %
Measured: 4 months
Stroke volume
Stroke volume in L
Measured: 4 months
Secondary outcomes (9)
Systolic Blood pressure
Resting systolic blood pressure in mmHg
Measured: 4 months
Diastolic Blood pressure
Resting diastolic blood pressure in mmHg
Measured: 4 months
Postprandial triglycerides
Postprandial triglycerides in mmol/L
Measured: 4 months
Postprandial total cholesterol
Postprandial total cholesterol in mmol/L
Measured: 4 months
Postprandial low density lipoprotein cholesterol
Postprandial low density lipoprotein cholesterol in mmol/L
Measured: 4 months
Postprandial high density lipoprotein cholesterol
Postprandial high density lipoprotein cholesterol in mmol/L
Measured: 4 months
Postprandial insulin
Postprandial insulin in mU/L
Measured: 4 months
Postprandial glucose
Postprandial glucose in mmol/L
Measured: 4 months
Mood and wellbeing
Positive affect and negative affect scale. This is a 5 point score, that asks 10 questions about positive feelings and 10 questions about negative feelings. The higher the score for each scale, the more likely they are feeling positive or negative.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start29 Nov 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion1 Jun 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 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
- Investigators
- Joanna Richards, PhD, Study director, University of BedfordshireAbbie C Bell, MSc, Principal investigator, Bedfordshire Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193175
- Sponsor's protocol ID
- 265468
- Acronym
- MOVE-MI
- Status last verified
- Mar 2023
- First submitted
- 6 Dec 2021
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon registration to the study, participants will be given a unique participant ID number, which will henceforth be used in all data collection within the study. This will be determined using a number system. A confidential log will be kept by the research team to identify participants with their anonymous ID numbers, which will be encrypted on a secure computer. All other electronic documentation will also be encrypted. Only direct members of the research team will have access to the data, and will be listed on the study's delegation log. Where data is transmitted to sponsors, if necessary, it will only be identifiable by its participant ID number, thus not becoming patient identifiable at any time.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breaking up Sitting Time on Cardiometabolic Risk Markers and Cardiac Function Post Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05193175
- Acronym / sponsor ID
- MOVE-MI / 265468
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of BedfordshireUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 14 Jan 2022 (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 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:
- Uninterrupted sitting for 6 hours.
- Sitting interrupted with 5 minutes of static standing every 30 minutes.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prolonged sitting | Experimental | Behavioral: Prolonged sittingUninterrupted sitting for 6 hours. |
| Sitting interrupted with standing | Experimental | Behavioral: Prolonged sittingSitting interrupted with 5 minutes of static standing every 30 minutes for 6 hours. |
| Sitting interrupted with light stepping | Experimental | Behavioral: Prolonged sittingSitting 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Prolonged sittingAlso: Sitting interrupted with standing, Sitting interrupted with light steppingCross 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 | Behavioural | Prolonged sitting, Sitting interrupted with light stepping, Sitting interrupted with standing |
Primary outcome
Posterior wall thickness
Time frame: 4 months
Posterior wall thickness in cm
Interventricular septum
Time frame: 4 months
Interventricular septum in cm
Left ventricular internal diameter
Time frame: 4 months
Left ventricular internal diameter in cm
Aortic root
Time frame: 4 months
Aortic root in cm
End volume
Time frame: 4 months
End volume in cm
E wave
Time frame: 4 months
E wave in ms
A wave
Time frame: 4 months
A wave in ms
Relative wall thickness
Time frame: 4 months
Relative wall thickness in cm
Left ventricular mass
Time frame: 4 months
Left ventricular mass in g
E/A ratio
Time frame: 4 months
E/A ratio
Deceleration time
Time frame: 4 months
Deceleration time in ms
Isovolumetric relaxation time
Time frame: 4 months
Isovolumetric relaxation time in ms
Ejection fraction
Time frame: 4 months
Ejection fraction in %
Stroke volume
Time frame: 4 months
Stroke volume in L
9 secondary outcomes
Systolic Blood pressure
Time frame: 4 months
Diastolic Blood pressure
Time frame: 4 months
Postprandial triglycerides
Time frame: 4 months
Postprandial total cholesterol
Time frame: 4 months
Postprandial low density lipoprotein cholesterol
Time frame: 4 months
Postprandial high density lipoprotein cholesterol
Time frame: 4 months
Postprandial insulin
Time frame: 4 months
Postprandial glucose
Time frame: 4 months
Mood and wellbeing
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No. Upon registration to the study, participants will be given a unique participant ID number, which will henceforth be used in all data collection within the study. This will be determined using a number system. A confidential log will be kept by the research team to identify participants with their anonymous ID numbers, which will be encrypted on a secure computer. All other electronic documentation will also be encrypted. Only direct members of the research team will have access to the data, and will be listed on the study's delegation log. Where data is transmitted to sponsors, if necessary, it will only be identifiable by its participant ID number, thus not becoming patient identifiable at any time.
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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.
Joanna Richards, PhD study director
University of Bedfordshire
Abbie C Bell, MSc principal investigator
Bedfordshire Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged sitting in people with Cardiovascular Diseases, run by University of Bedfordshire at 1 site in United Kingdom.
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 9 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 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Abbie C Bell, MSc (07984545911, abbie.bell@study.beds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posterior wall thickness (time frame: 4 months). The study lists 14 primary outcomes in all. 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 3 Mar 2023.