None listed
Conditions
Brief summary
Exercise is seen as a vital component for the prevention and treatment of type 2 diabetes mellitus due to its ability to regulate blood sugar levels with little to no unwanted side effects. Physical exercise also has a number of other benefits which improve overall health and well-being. Furthermore, exercise training also lowers the risk of developing other diseases which could eventuate as a result of type 2 diabetes such as cardiovascular disease. While it is suggested that patients with type 2 diabetes exercise at a moderate intensity for at least 210 minutes per week, this is often unachievable as patients struggle to find the time to fit in 210 minutes of exercise into their busy schedules. Therefore, as an alternative, exercise that is of a high-intensity has been suggested as it requires less time to be completed but offers similar benefits. A further problem to time is the effectiveness of an exercise programme outside a supervised setting. While a training programme is effective in a supervised setting with a high rate of attendance, away from a supervised setting exercise levels are not maintained and improvements achieved quickly diminish. However, because motivation and time are often the barriers to exercise away from a supervised setting, reducing time required to exercise and increasing motivation may lead to better exercise adherence away from a supervised setting. The objective of the study is to investigate the effectiveness of short duration high-intensity interval aerobic + resistance training compared to training using the current recommendations of 210 minutes of exercise at a moderate intensity per week on blood glucose control in patients with type 2 diabetes mellitus. Furthermore, this study will also investigate the effectiveness of a novel technology-based program designed to help maintain exercise and fitness after the completion of a supervised 8-week training period. Hypotheses: Combined short-duration high-intensity interval aerobic and resistance training will be as effective as current recommendations in reducing glycated haemoglobin level (HbA1c). A novel technology-based program will improve adherence and help maintain exercise and fitness after the completion of a supervised 8-week training period.
Interventions
Patients meeting the criteria for inclusion into this study will initially be randomised to one of three groups; short duration combined high-intensity interval aerobic + resistance training (C-HIIT), current recommendations (CR), or Control Waitlist 1. Patients in the Control Waitlist group will be randomised to either C-HIIT or CR after 8 weeks.
Exercise Intervention – Phase One:
This study will involve two exercise intervention groups; 1) short duration combined high-intensity interval aer
Patients meeting the criteria for inclusion into this study will initially be randomised to one of three groups; short duration combined high-intensity interval aerobic + resistance training (C-HIIT), current recommendations (CR), or Control Waitlist 1. Patients in the Control Waitlist group will be randomised to either C-HIIT or CR after 8 weeks. Exercise Intervention – Phase One: This study will involve two exercise intervention groups; 1) short duration combined high-intensity interval aerobic + resistance training (C-HIIT) and 2) training using the current recommendations (CR). Phase 1 will involve 8 weeks of supervised training. The preferred mode for exercise will be treadmill walking/running, however, if patients are not able to perform treadmill walking/running, they will have the option of using another mode such as cycling or rowing. During phase 1, the short duration C-HIIT group will warm-up for 3 minutes at 60% of maximal heart rate (HRmax) before performing 4 minutes of high-intensity aerobic exercise followed by 1 minute rest and then 4 minutes of high-intensity interval resistance exercise before a warm-down for 3 minutes, also at 60% of HRmax. The 4 minutes of high-intensity aerobic exercise will consist of 1 x 4 minutes of aerobic exercise at 90% of HRmax. For the 4 minutes of high-intensity interval resistance exercise, patients will perform a mixture of upper and lower body resistance-type exercises at an intensity of 80% of their 1 repetition maximum (1RM) for 8 x 20 second bouts each separated by 10 seconds of recovery. The short duration C-HIIT group will train 3/week on non-consecutive days. The CR group will warm-up for 3 minutes at 60% of HRmax before performing 20 minutes of aerobic exercise at 55-69% of HRmax, then 15 minutes of upper and lower body resistance-type exercises at a moderate intensity, followed by 17 minutes and 30 seconds of aerobic exercise at 55-69% of HRmax before a warm-down for 3 minutes also at 60% of HRmax. The CR group will train 4/week. Exercise Intervention plus Activity Monitoring Device – Phase Two: Phase 2 will involve 10 months of home-based training and will follow phase 1. For phase 2, patients from C-HIIT and CR will be randomised to either SMART-FIT or non-SMART-FIT. The SMART-FIT patients will be allocated an activity monitoring device, the associated activity monitoring device smartphone app, a smartphone app (a computer will be used if the patient has no access to a smartphone) for a non-exercise fitness test, and a tape measure. SMART-FIT will allow patients to monitor their own physical activity levels and fitness and also allow an Accredited Exercise Physiologist to view the information and provide monthly feedback to the patient as the data will be uploaded to a community website that is associated with the activity monitoring device. This website will also provide patients with ongoing community support as the website allows patients to participate in an online social community. The goal of SMART-FIT is to help maintain and/or improve the physical fitness gains obtained during phase 1. The non-SMART-FIT group will not receive this support during phase 2 and instead will be given an exercise programme to adhere to, information regarding the role exercise plays in type 2 diabetes, and monthly check-up phone calls. Patients in both SMART-FIT and non-SMART-FIT will be given an exercise programme which continues what they had been doing based on their allocation during phase 1.
Sponsors
Trishan Gajanand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Male and female patients with type 2 diabetes mellitus aged 18-75 years will be included in this study. The diagnostic criteria for type 2 diabetes mellitus is confirmation of the disease from the patients’ medical doctor and either a fasting glucose level of 7.0 mmol/L or greater or a glycated haemoglobin level that is greater than 6.5%. Access to a smartphone or computer will be required.
Exclusion criteria
Unstable angina; Recent (4 weeks) myocardial infarction; Coronary Artery Disease; Uncompensated heart failure; New York Heart Association (NYHA) Functional Classification II-IV; Severe valvular illness; Pulmonary disease; Uncontrolled hypertension (systolic blood pressure > 200 mmHg and/or diastolic blood pressure >110 mmHg); Renal failure (Chronic Kidney Disease stages III-V); Orthopaedic/neurological limitations; Cardiomyopathy; Planned operations during the research period; Physical impairment limiting the ability to exercise; Drug or alcohol abuse; Planning to or participation in another study; Not willing to sign the consent from; Females pregnant or expecting to be pregnant during the study period; Any other reason which would limit their ability to participate in this study.
Outcome results
None listed