Type 2 Diabetes
Conditions
Keywords
Blood flow restriction, aerobic exercise, cardiorespiratory fitness, glycemia, feasability, physical activity, diabetes, continuious glucose monitor
Brief summary
The goal of this trial is to learn if blood flow restriction training with treadmill walking is possible for individuals living with type 2 diabetes. It will also learn about how the blood flow restriction with treadmill walking could improve health. The main questions it aims to answer are: Is 6 weeks of treadmill walking with blood flow restriction reasonable for people with type 2 diabetes to perform? Does treadmill walking with blood flow restriction training help manage type 2 diabetes better than just treadmill walking? Researchers will compare treadmill walking with blood flow restriction to treadmill walking without blood flow restriction to see if blood flow restriction works to manage type 2 diabetes based on fitness and blood sugar levels. Participants will: Perform treadmill walking with or without blood flow restriction for 96 minutes a week for 6 weeks. Visit the lab before and after the exercise for tests and questionnaires.
Detailed description
Individuals with type 2 diabetes (T2D) display reduced cardiorespiratory fitness, which is a strong predictor of premature mortality and T2D-related complications. Aerobic training (AT) enhances cardiorespiratory fitness and is considered a cornerstone in the management and treatment of T2D. Emerging data suggest that AT combined with blood flow restriction (AT+BFR) training, could potentially enhance cardiorespiratory fitness faster than typical AT in healthy individuals. However, the feasibility of AT+BFR in individuals with T2D and its impact on cardiorespiratory fitness have yet to be determined. Therefore, the primary objective of this study is to test the feasibility of a 6-week AT+BFR training intervention in individuals with T2D. The secondary objective is to establish preliminary effect sizes for the efficacy of AT+BFR training in individuals with T2D compared to the standard care AT (AT- stdCare). Methods: This study is a single-blind (investigator & statistical analyst), multi-site, randomized controlled pilot trial of a novel AT+BFR training intervention for individuals living with T2D, which has been informed by patients with lived experience. Participants will be randomized 1:1 using variable permuted block sizes (stratified by sex and site) into 1) AT+BFR or 2) AT-stdCare groups with outcome measures assessed at baseline and 6 weeks. Population: In 3 sites across Canada, 60 (n=20 per site) individuals living with T2D (5.7% \< HbA1c \< 9.0%) aged 19-64 years, not meeting the physical activity guidelines (150 mins moderate-vigorous physical activity per week) will be recruited to participate in this 6-week pilot trial. Intervention: Participants will perform supervised AT+BFR 3 times weekly for 32 minutes per session. A blood pressure cuff will be set between 60-80% of limb arterial occlusion with AT for 96 minutes per week of treadmill walking performed at 40-50% of heart rate reserve (HRR). Participants in the AT-stdCare will perform 96 minutes per week of treadmill walking at 40-50% of HRR following the same schedule as AT+BFR, training 3 times per week for 32 minutes per session. Outcomes: The main outcome measures will pertain to the feasibility of a larger trial and include recruitment rates, enrollment and adherence to the intervention, and retention for follow-up testing. The secondary outcomes will be focused on establishing effect sizes to power a larger trial. Effect sizes for the change in cardiorespiratory fitness and continuous glucose monitoring (CGM) outcomes will be determined to help select and power a primary outcome for a more definitive trial of AT+BFR.
Interventions
BEHAVIORALAerobic Training with Blood Flow Restriction
Participants will undergo a 6-week aerobic training intervention with blood flow restriction applied to the lower limbs. Blood flow restriction will be applied using a blood pressure cuff set between 60-80% of limb arterial occlusion pressure. Training will consist of treadmill walking at 40-50% of heart rate reserve (HRR) for 32 minutes per session, 3 times per week for a total of 96 minutes per week.
BEHAVIORALStandard Aerobic Training
Participants will follow the same aerobic training protocol as the AT+BFR group but without blood flow restriction. Training will consist of treadmill walking at 40-50% of HRR for 32 minutes per session, 3 times per week for a total of 96 minutes per week.
Sponsors
University of New Brunswick
Diabetes Canada
University of Guelph
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
single-blind, multi-site, randomized controlled pilot trial
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes (5.7% \< HbA1c \< 9.0%) * Not regularly physically active (150 mins moderate-vigorous physical activity per week)
Exclusion criteria
* Musculoskeletal issues preventing exercise training * Unstable medications over the last 3 months * Absolute contraindications to BFR (i.e. peripheral vascular disease) * A self-reported diagnosis of low iron concentrations, anemia, or being treated for these conditions * A diagnosis of any red blood cell-altering condition (i.e., sickle cell anemia, poikilocytosis) * Currently living with any cardiovascular disease, which would impact the ability to participate in exercise safely * Currently prescribed any medication which would impact the ability to use a heart rate monitor to accurately track intensity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Recruitment | Every 4 weeks up to 2 years | Recruitment rate will be assessed as the number of individuals who inquire about the trial. |
| Rate of Enrollment | Every 4 weeks up to 2 years | Enrollment rate will be assessed as the number of eligible participants who consent to participate in the trial and are randomized to one of the two study arms out of the total number of eligible individuals recruited. |
| Adherence to the Intervention | From enrollment to the end of intervention at week 6 | Adherence to the intervention will be assessed as the number of sessions that the participant attended out of the total number of sessions. |
| Rate of Retention for Follow-Up Testing | Every 6 weeks up to 2 years | Retention rate will be assessed as the number of participants who complete follow-up testing measurements six weeks after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiorespiratory Fitness (VO2max) | 6 Weeks | Establishing effect size to power future trials (VO2max) |
| Glycemia (CGM/HbA1c) | 6 Weeks | Establishing effect size to power future trials (CGM/HbA1c) |
| Quality of Life (36-Item Short Form Health Survey (SF-36)) | 6 Weeks | Establishing effect size to power future trials (SF-36). Scores range from 0-100 for eight domains of health, with higher scores indicating better health-related quality of life and lower scores indicating poorer health-related quality of life. |
Countries
Canada
Contacts
CONTACTMartin Senechal, PhD
CONTACTJamie Burr, PhD
PRINCIPAL_INVESTIGATORMartin Senechal, PhD
Cardiometabolic Exercise & Lifestyle Laboratory, Fredericton, New Brunswick
Outcome results
None listed