Diabetes Mellitus, Type 2BURSTNCT03103854
Novel Strategies to Improve Cardiometabolic Status and Adherence to Exercise Regimens in Patients at High Risk for Cardiovascular Disease
A study testing BURST physical activity, Text Message Reminders and Moderate Intensity Continuous Training in people with Diabetes Mellitus, Type 2 and Myocardial Infarction, run by Cambridge Cardiac Care Centre at 1 site in Canada.
Trial summary
This is a 2x2 study examining the impacts of a novel exercise regimen and daily text message reminders in patients at high risk for cardiovascular disease. Patients participating in cardiac rehabilitation will be randomized to either moderate intensity continuous training (MICT) or a novel exercise regimen consisting… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- BURST physical activity, Text Message Reminders and Moderate Intensity Continuous Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2014to 31 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed type 2 diabetic patients (within the last 3 months)
- Participating in on-site the diabetes rehabilitation program at Cambridge Cardiac Rehab
- Deemed capable of high-intensity exercise
Who cannot join
- Known or suspected cardiovascular disease
- Diabetic end-organ damage
- Cerebrovascular disease
- Peripheral vascular disease
- Arthritis
- Joint disease
Show all 9Show fewer
- Taking anti-glycemic medications
- Taking lipid lowering medications
- Ischemia, hypoxia, arrhythmia or hemodynamic instability during a stress test
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Cambridge Cardiac Rehab
Cambridge, Ontario, N1R 6V6
A. Shekhar Pandey, BSc, MD, 5195906127, pandey@rogers.com
M. Michelle Pandey, B Pharm, (519) 624-3511, michellepandey@rogers.com
About this study
Official title: The Impact of Novel Strategies to Improve Cardiometabolic Status and Adherence to Exercise Regimens in Patients at High Risk for Cardiovascular Disease
This is a 2x2 study examining the impacts of a novel exercise regimen and daily text message reminders in patients at high risk for cardiovascular disease. Patients participating in cardiac rehabilitation will be randomized to either moderate intensity continuous training (MICT) or a novel exercise regimen consisting of three periods of high intensity exercise, called BURST exercise. Additionally, half of the patients in each exercise group will be randomized to receive daily text message reminders to improve adherence to the prescribed exercise regimen.
Read the detailed description
Numerous studies have demonstrated the important cardiometabolic impacts of high intensity exercise in patients at high risk for cardiovascular disease. It is also known that adherence to exercise regimens is poor within these populations. This study compares the impacts of the current standard of care, moderate intensity continuous training (MICT) to a novel exercise regimen called BURST exercise within a population of patients at high risk for cardiovascular disease. BURST exercise consists of three periods of high intensity physical activity spread throughout the day. Additionally, as mobile technologies continue to be used more to improve adherence to exercise regimens, this study also seeks to compare the impacts of text message reminders in patients prescribed each of the exercise regimens examined in this study. Thus, patients were also randomized to either receive daily text message reminders, or to receive no text message reminders.
Recruitment will be conducted at Cambridge Cardiac Rehab in Ontario, Canada. Potential study subjects are evaluated for inclusion and exclusion criteria, give written informed consent, and are randomized, in a 1:1 ratio, to either MICT or BURST exercise. Additionally, patients are then randomized in a 1:1 ratio to either receive text message reminders or not receive text message reminders.
Patients prescribed the MICT regimen will be asked to exercise for 30 minutes per day at moderate intensity, at least five days per week. Patients prescribed the BURST exercise regimen will be asked to exercise for 10 minutes per session, three times a day at high intensity, at least five days per week. Patients randomized to receive text message reminders will be sent four daily text message reminders reading: "Please remember to exercise for 30 minutes today."
Adherence to exercise regimens will be measured by daily logbooks. Patients are asked to log the times they exercised and for what duration. BRUCE protocol stress tests will be conducted for all patients at baseline (before beginning the study), after three months and after one year. Hemoglobin A1C blood tests, height and weight measurements and lipid profile blood tests will also be conducted at baseline (before the beginning of the study), after three months and after one year.
- Conditions
- Diabetes Mellitus, Type 2, Myocardial Infarction, Coronary Artery Disease, Atrial Fibrillation, Congestive Heart Failure
- Being tested
- BURST physical activity, Text Message Reminders, Moderate Intensity Continuous Training
- Keywords
- Exercise, Secondary Prevention, Diabetes, Rehabilitation
- Medical subject headings
- Diabetes Mellitus, Type 2, Myocardial Infarction, Coronary Artery Disease, Atrial Fibrillation, Heart Failure, Motor Activity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BURST physical activityBehavioural
Also called Exercise Snacks
BURST is a novel exercise regimen consisting of three daily periods of 10 minutes of high intensity physical activity spread throughout the day.
Text Message RemindersBehavioural
Patients were sent daily text message reminders to remind them to exercise.
Moderate Intensity Continuous TrainingBehavioural
Also called MICT
This is the current standard of care for cardiac rehabilitation patients. It consists of 1 daily period of 30 minutes of moderate intensity physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients in the "Control" arm of the study performed Moderate Intensity Continuous Training (MICT) and did not receive text message reminders. Receives: Behavioral: Moderate Intensity Continuous Training |
| BURST | Experimental | Patients in the "BURST" arm of the study performed BURST physical activity and did not receive text message reminders Receives: Behavioral: BURST physical activity |
| Text Message Reminders | Experimental | Patients in the "Text Message Reminders" arm of the study performed Moderate Intensity Continuous Training and received text message reminders. Receives: Behavioral: Text Message Reminders; Behavioral: Moderate Intensity Continuous Training |
| BURST and Text Message Reminders | Experimental | Patients in the "BURST and Text Message Reminders" arm of the study performed Burst physical activity and received text message reminders Receives: Behavioral: BURST physical activity; Behavioral: Text Message Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C at 12 months
Hemoglobin A1C blood test
Measured: 12 months
Secondary outcomes (12)
LDL at 3 months
Calculated Low Density Lipoprotein from blood tests
Measured: 3 months
LDL at 12 months
Calculated Low Density Lipoprotein from blood tests
Measured: 12 months
HDL at 3 months
Measured High Density Lipoprotein from blood tests
Measured: 3 months
HDL at 12 months
Measured High Density Lipoprotein from blood tests
Measured: 12 months
Triglycerides at 3 months
Measured Triglycerides from blood tests
Measured: 3 months
Triglycerides at 12 months
Measured Triglycerides from blood tests
Measured: 12 months
BMI at 3 months
Calculated Body Mass Index based on height and weight measurements
Measured: 3 months
BMI at 12 months
Calculated Body Mass Index based on height and weight measurements
Measured: 12 months
Exercise Capacity at 3 months
Timed number of minutes achieved on a Bruce Protocol treadmill stress test
Measured: 3 months
Exercise Capacity at 12 months
Timed number of minutes achieved on a Bruce Protocol treadmill stress test
Measured: 12 months
Monthly Duration of Exercise
Average number of minutes of exercise logged by patients in daily logbooks
Measured: Months 1-12
HbA1C at 3 months
Hemoglobin A1C blood test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start1 Jan 2014
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Factorial
- Model description
- This is a 2x2 of burst physical activity (BURST) vs moderate intensity continuous training (MICT) and text message reminders vs no text message reminders. Patients will be randomized to either BURST or MICT and then further randomized to either receive text message reminders or not receive text message reminders.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge Cardiac Care Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Avinash Pandey, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103854
- Sponsor's protocol ID
- CCCBE1418
- Acronym
- BURST
- Status last verified
- Jul 2018
- First submitted
- 28 Mar 2017
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaede P, Lund-Andersen H, Parving HH, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008 Feb 7;358(6):580-91. doi: 10.1056/NEJMoa0706245.
PubMed 18256393Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
PubMed 11832527Armstrong MJ, Sigal RJ, Arena R, Hauer TL, Austford LD, Aggarwal S, Stone JA, Martin BJ. Cardiac rehabilitation completion is associated with reduced mortality in patients with diabetes and coronary artery disease. Diabetologia. 2015 Apr;58(4):691-8. doi: 10.1007/s00125-015-3491-1. Epub 2015 Jan 26.
PubMed 25742772Francois ME, Little JP. Effectiveness and safety of high-intensity interval training in patients with type 2 diabetes. Diabetes Spectr. 2015 Jan;28(1):39-44. doi: 10.2337/diaspect.28.1.39.
PubMed 25717277Thakkar J, Kurup R, Laba TL, Santo K, Thiagalingam A, Rodgers A, Woodward M, Redfern J, Chow CK. Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease: A Meta-analysis. JAMA Intern Med. 2016 Mar;176(3):340-9. doi: 10.1001/jamainternmed.2015.7667.
PubMed 26831740
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Novel Strategies to Improve Cardiometabolic Status and Adherence to Exercise Regimens in Patients at High Risk for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT03103854
- Acronym / sponsor ID
- BURST / CCCBE1418
- Conditions
- Diabetes Mellitus, Type 2, Myocardial Infarction, Coronary Artery Disease, Atrial Fibrillation, Congestive Heart Failure
- Keywords
- Exercise, Secondary Prevention, Diabetes, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cambridge Cardiac Care CentreUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 6 Apr 2017 (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.
This is a 2x2 study examining the impacts of a novel exercise regimen and daily text message reminders in patients at high risk for cardiovascular disease. Patients participating in cardiac rehabilitation will be randomized to either moderate intensity continuous training (MICT) or a novel exercise regimen consisting of three periods of high intensity exercise, called BURST exercise. Additionally, half of the patients in each exercise group will be randomized to receive daily text message reminders to improve adherence to the prescribed exercise regimen.
Detailed description
Numerous studies have demonstrated the important cardiometabolic impacts of high intensity exercise in patients at high risk for cardiovascular disease. It is also known that adherence to exercise regimens is poor within these populations. This study compares the impacts of the current standard of care, moderate intensity continuous training (MICT) to a novel exercise regimen called BURST exercise within a population of patients at high risk for cardiovascular disease. BURST exercise consists of three periods of high intensity physical activity spread throughout the day. Additionally, as mobile technologies continue to be used more to improve adherence to exercise regimens, this study also seeks to compare the impacts of text message reminders in patients prescribed each of the exercise regimens examined in this study. Thus, patients were also randomized to either receive daily text message reminders, or to receive no text message reminders.
Recruitment will be conducted at Cambridge Cardiac Rehab in Ontario, Canada. Potential study subjects are evaluated for inclusion and exclusion criteria, give written informed consent, and are randomized, in a 1:1 ratio, to either MICT or BURST exercise. Additionally, patients are then randomized in a 1:1 ratio to either receive text message reminders or not receive text message reminders.
Patients prescribed the MICT regimen will be asked to exercise for 30 minutes per day at moderate intensity, at least five days per week. Patients prescribed the BURST exercise regimen will be asked to exercise for 10 minutes per session, three times a day at high intensity, at least five days per week. Patients randomized to receive text message reminders will be sent four daily text message reminders reading: "Please remember to exercise for 30 minutes today."
Adherence to exercise regimens will be measured by daily logbooks. Patients are asked to log the times they exercised and for what duration. BRUCE protocol stress tests will be conducted for all patients at baseline (before beginning the study), after three months and after one year. Hemoglobin A1C blood tests, height and weight measurements and lipid profile blood tests will also be conducted at baseline (before the beginning of the study), after three months and after one year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a 2x2 of burst physical activity (BURST) vs moderate intensity continuous training (MICT) and text message reminders vs no text message reminders. Patients will be randomized to either BURST or MICT and then further randomized to either receive text message reminders or not receive text message reminders.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Moderate Intensity Continuous TrainingPatients in the "Control" arm of the study performed Moderate Intensity Continuous Training (MICT) and did not receive text message reminders. |
| BURST | Experimental | Behavioral: BURST physical activityPatients in the "BURST" arm of the study performed BURST physical activity and did not receive text message reminders |
| Text Message Reminders | Experimental | Behavioral: Text Message Reminders, Behavioral: Moderate Intensity Continuous TrainingPatients in the "Text Message Reminders" arm of the study performed Moderate Intensity Continuous Training and received text message reminders. |
| BURST and Text Message Reminders | Experimental | Behavioral: BURST physical activity, Behavioral: Text Message RemindersPatients in the "BURST and Text Message Reminders" arm of the study performed Burst physical activity and received text message reminders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed type 2 diabetic patients (within the last 3 months)
- Participating in on-site the diabetes rehabilitation program at Cambridge Cardiac Rehab
- Deemed capable of high-intensity exercise
Key exclusion criteria (9 listed)
- Known or suspected cardiovascular disease
- Diabetic end-organ damage
- Cerebrovascular disease
- Peripheral vascular disease
- Arthritis
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 |
|---|---|---|
| BURST physical activityAlso: Exercise SnacksBURST is a novel exercise regimen consisting of three daily periods of 10 minutes of high intensity physical activity spread throughout the day. | Behavioural | BURST, BURST and Text Message Reminders |
| Text Message RemindersPatients were sent daily text message reminders to remind them to exercise. | Behavioural | BURST and Text Message Reminders, Text Message Reminders |
| Moderate Intensity Continuous TrainingAlso: MICTThis is the current standard of care for cardiac rehabilitation patients. It consists of 1 daily period of 30 minutes of moderate intensity physical activity. | Behavioural | Control, Text Message Reminders |
Primary outcome
HbA1C at 12 months
Time frame: 12 months
Hemoglobin A1C blood test
12 secondary outcomes
LDL at 3 months
Time frame: 3 months
LDL at 12 months
Time frame: 12 months
HDL at 3 months
Time frame: 3 months
HDL at 12 months
Time frame: 12 months
Triglycerides at 3 months
Time frame: 3 months
Triglycerides at 12 months
Time frame: 12 months
BMI at 3 months
Time frame: 3 months
BMI at 12 months
Time frame: 12 months
Exercise Capacity at 3 months
Time frame: 3 months
Exercise Capacity at 12 months
Time frame: 12 months
Monthly Duration of Exercise
Time frame: Months 1-12
HbA1C at 3 months
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Background: PubMed 18256393Gaede P, Lund-Andersen H, Parving HH, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008 Feb 7;358(6):580-91. doi: 10.1056/NEJMoa0706245.
- Background: PubMed 11832527Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Background: PubMed 25742772Armstrong MJ, Sigal RJ, Arena R, Hauer TL, Austford LD, Aggarwal S, Stone JA, Martin BJ. Cardiac rehabilitation completion is associated with reduced mortality in patients with diabetes and coronary artery disease. Diabetologia. 2015 Apr;58(4):691-8. doi: 10.1007/s00125-015-3491-1. Epub 2015 Jan 26.
- Background: PubMed 25717277Francois ME, Little JP. Effectiveness and safety of high-intensity interval training in patients with type 2 diabetes. Diabetes Spectr. 2015 Jan;28(1):39-44. doi: 10.2337/diaspect.28.1.39.
- Background: PubMed 26831740Thakkar J, Kurup R, Laba TL, Santo K, Thiagalingam A, Rodgers A, Woodward M, Redfern J, Chow CK. Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease: A Meta-analysis. JAMA Intern Med. 2016 Mar;176(3):340-9. doi: 10.1001/jamainternmed.2015.7667.
- 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.
Avinash Pandey principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BURST physical activity, Text Message Reminders and Moderate Intensity Continuous Training in people with Diabetes Mellitus, Type 2 and Myocardial Infarction, run by Cambridge Cardiac Care Centre at 1 site in Canada.
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 3 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 26 Jul 2018. 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 Canada. 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 Avinash Pandey (2267502167, apandey4@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03103854, which also lists 5 linked publications.
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 26 Jul 2018.