Movement Breaks for Type 2 Diabetes

Overseen By Jonathan P Little, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Insulin, Beta-blockers, Statins

Disqualifiers: Severe hypoglycemia, Smoking, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how short, low-intensity movement breaks affect blood sugar levels in people with type 2 diabetes who exercise infrequently. Participants will be divided into two groups: one will perform stretching and mobility exercises four times a day for two days, while the other will not engage in any structured exercise during that period. The trial seeks individuals with type 2 diabetes who exercise less than 150 minutes a week and can travel to McMaster University for certain tests. As an unphased trial, this study offers a unique opportunity to contribute to understanding how simple lifestyle changes can impact diabetes management.

Do I have to stop taking my current medications for the trial?

No, you can continue taking your current medications as long as the dosage has been stable for at least 6 months and you can maintain the same doses during the study.

What prior data suggests that these movement breaks are safe for individuals with type 2 diabetes?

Research shows that short movement breaks are safe for people with type 2 diabetes. Studies have found that interrupting long periods of sitting with brief, easy exercises can help control blood sugar levels. Participants usually respond well to these activities, which are recommended for those with type 2 diabetes.

No serious side effects are known from these short exercise sessions, often called "exercise snacks." Regular physical activity is often advised to help manage diabetes and improve overall health. While this trial does not test a new drug, current guidelines for diabetes care support the safety of movement breaks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about movement breaks for managing Type 2 Diabetes because these low-intensity exercises offer a unique, manageable approach to controlling blood sugar levels without the need for medications or intensive workouts. Unlike standard treatments that often involve daily medication or structured exercise programs, these brief, one-minute stretching and mobility exercises can be easily integrated into daily routines. This approach not only makes it more accessible for individuals who may struggle with traditional exercise routines but also promotes consistent movement, which can help improve insulin sensitivity and overall metabolic health.

What evidence suggests that movement breaks are effective for type 2 diabetes?

Research has shown that taking breaks from sitting to move around can help control blood sugar in people with type 2 diabetes. In this trial, participants in the Exercise (EX) arm will engage in low-intensity movement breaks, including stretching and mobility-based exercises lasting 1 minute each, performed four times per day on two consecutive days. Studies have found that being active after meals can lower blood sugar levels. Even simple activities like stretching can improve blood sugar and insulin levels. Regular movement throughout the day is also linked to better heart health and overall well-being. These findings suggest that adding short movement breaks during the day may help manage type 2 diabetes effectively. ^{1 2 3 6 7}

Who Is on the Research Team?

Jonathan Little, PhD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for inactive adults aged 30-75 with type 2 diabetes, a BMI of 18.5-40, stable medication doses for the past 6 months, and an HbA1c of ≤8.5%. Participants must not be doing more than 150 minutes of moderate exercise weekly and should have access to digital devices for intervention tracking.

Inclusion Criteria

Currently participating in less than 150 minutes of moderate-to-vigorous intensity aerobic exercise per week

Have a body mass index between 18.5 and 40 kg/m2

Have access to a computer, tablet, or smartphone for intervention delivery and tracking

Exclusion Criteria

I am currently taking beta-blockers.

I am on 3 or more medications for heart disease prevention.

I have a long-term muscle or bone condition that stops me from exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Exercise Condition (EX)

Participants perform four low-intensity movement breaks per day on two consecutive days while wearing a continuous glucose monitor

2 days

No in-person visits required

Control Condition (CON)

Participants refrain from any structured exercise during two consecutive days while wearing a continuous glucose monitor

2 days

No in-person visits required

Follow-up

Participants are monitored for safety and effectiveness after the trial conditions

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Movement breaks

Trial Overview The study tests if taking short breaks to move around can help control blood sugar levels in people with type 2 diabetes. It's a randomized crossover trial using continuous glucose monitoring to compare periods with and without movement breaks.

How Is the Trial Designed?

Group I: Exercise (EX): Low-intensity movement breaks condition Experimental Treatment 1 Intervention

Stretching and mobility-based exercises lasting 1-minute each performed 4 times per day on two consecutive days.

Group II: Control (CON) Non-exercise control condition Active Control 1 Intervention

No structured exercise on two consecutive days.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

Physical activity is crucial for preventing and managing type 2 diabetes and cardiovascular risks, but individuals with diabetes face higher risks of injury during exercise due to complications associated with the disease.

To ensure safe exercise for people with type 2 diabetes, it is important to tailor exercise programs to individual health conditions and complications, such as diabetic foot and retinopathy, while implementing preventative measures to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of exercise-related injuries and adverse events in patients with type 2 diabetes. Mendes, R., Sousa, N., Reis, VM., et al.[2013]

Physical activity is a crucial and effective therapy for improving outcomes in patients with type 2 diabetes mellitus (T2DM), yet it is often underutilized due to inadequate emphasis from healthcare professionals.

An effective exercise prescription for T2DM should be personalized, considering the type, frequency, intensity, duration, and progression of activities to ensure safety and optimize patient compliance and health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise prescription and the patient with type 2 diabetes: a clinical approach to optimizing patient outcomes. Waryasz, GR., McDermott, AY.[2010]

Interrupting prolonged sitting with short activity breaks led to a modest reduction in fasting glucose levels and daily glucose variation in 16 adults with obesity, suggesting potential benefits for glycemic control.

Despite these improvements, the intervention did not significantly affect glucose tolerance or the skeletal muscle lipid profile, indicating that more extensive activity may be necessary for greater health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three weeks of interrupting sitting lowers fasting glucose and glycemic variability, but not glucose tolerance, in free-living women and men with obesity. Smith, JAB., Savikj, M., Sethi, P., et al.[2021]

Regular physical exercise is crucial for both preventing and treating type 2 diabetes, leading to benefits such as improved insulin sensitivity, better glycemic control, and enhanced cardiovascular health.

Before starting an exercise program, individuals with type 2 diabetes should undergo a thorough medical evaluation to assess their cardiovascular health and any complications, ensuring a safe and effective exercise plan that gradually increases in intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and exercise in type 2 diabetes mellitus. Hamdy, O., Goodyear, LJ., Horton, ES.[2019]

The study identified a four-stage process that individuals with prediabetes go through when developing exercise habits, starting from awareness and culminating in spontaneous regular exercise, highlighting the challenges they face in maintaining a routine.

Participants experienced an 'action cycle of internal struggle,' indicating that both motivating and resisting factors influence their ability to continue or discontinue exercise, which can inform healthcare providers in creating supportive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise engagement in people with prediabetes--a qualitative study. Kuo, YL., Wu, SC., Hayter, M., et al.[2018]

The six-week physical activity intervention for patients with type 2 diabetes did not show significant differences between the intervention and control groups, but it did lead to a decrease in HbA1c levels and increases in self-reported physical activity and physical fitness over time.

The study suggests that while the overall intervention may not have had the expected impact, regular expert visits and monitoring could still be beneficial for managing diabetes and promoting physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short- and long-term effects of a need-supportive physical activity intervention among patients with type 2 diabetes mellitus: A randomized controlled pilot trial. Vanroy, J., Seghers, J., Bogaerts, A., et al.[2022]

Regular physical activity can significantly reduce the risk of developing type 2 diabetes (T2D) by 50% in individuals with high metabolic risk and improve glycemic control by lowering HbA1c levels by an average of 0.7%.

The benefits of physical activity extend beyond just one-time exercise sessions, as consistent training leads to long-term improvements in blood pressure, lipid profiles, and insulin resistance, with recommendations tailored to fit individual preferences and lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and type 2 diabetes. Recommandations of the SFD (Francophone Diabetes Society) diabetes and physical activity working group. Duclos, M., Oppert, JM., Verges, B., et al.[2013]

A systematic review of 5 randomized controlled trials involving 549 participants found that structured exercise interventions can lead to significant improvements in physical activity levels and body composition shortly after the intervention, but these benefits may not be sustained long-term.

Only one of the studies showed lasting improvements in physical activity levels up to 5 years post-intervention, highlighting the need for further research on how to maintain increased physical activity after structured exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Physical Activity Levels After the End of a Structured Exercise Intervention in Adults With Type 2 Diabetes and Prediabetes: A Systematic Review. Booth, JE., Benham, JL., Schinbein, LE., et al.[2021]

The Italian Diabetes and Exercise Study (IDES)-2 is a randomized controlled trial involving 300 patients with type 2 diabetes, aiming to test a behavior change strategy to increase physical activity and reduce sedentary time over a 3-year period.

The intervention group receives comprehensive exercise counseling, which is expected to improve daily physical activity levels and overall health outcomes, while the control group receives standard care, allowing for a robust comparison of efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Italian Diabetes and Exercise Study 2 (IDES-2): a long-term behavioral intervention for adoption and maintenance of a physically active lifestyle. Balducci, S., Sacchetti, M., Haxhi, J., et al.[2018]

In a study of 40 newly diagnosed type 2 diabetes patients, burst high-intensity exercise led to a greater reduction in body mass index and hemoglobin A1C levels compared to traditional moderate-intensity continuous exercise over 3 months.

Burst exercise also improved cholesterol profiles more effectively, resulting in a greater decrease in low-density lipoprotein (LDL) and a significant increase in high-density lipoprotein (HDL) cholesterol, along with enhanced exercise capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Burst Exercise on Cardiometabolic Status of Patients Newly Diagnosed With Type 2 Diabetes. Pandey, A., Suskin, N., Poirier, P.[2018]

Structured exercise programs significantly increased physical activity levels in individuals with type 2 diabetes, showing larger effect sizes compared to behavioral interventions, based on a review of 23 randomized controlled trials involving 9,640 participants.

Behavioral interventions also improved physical activity, particularly when they included more extensive and face-to-face counseling, although the overall effect was smaller than that of structured exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Structured Exercise or Lifestyle Behavior Interventions on Long-Term Physical Activity Level and Health Outcomes in Individuals With Type 2 Diabetes: A Systematic Review, Meta-Analysis, and Meta-Regression. Mosalman Haghighi, M., Mavros, Y., Fiatarone Singh, MA.[2019]

In a study of 140 sedentary individuals with type 2 diabetes, those assigned to an exercise program had a higher dropout rate compared to the control group, indicating challenges in maintaining participation in exercise interventions.

Key predictors of dropout included low exercise self-efficacy, poor fitness levels, and higher insulin resistance, suggesting that tailored support for individuals with these characteristics may enhance retention in exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of exercise intervention dropout in sedentary individuals with type 2 diabetes. Nam, S., Dobrosielski, DA., Stewart, KJ.[2023]

The Brain Breaks® videos significantly improved the perceived benefits (Pros) of exercise and reduced the perceived barriers (Cons) to exercise in individuals with type 2 diabetes mellitus (T2DM) over a four-month period, based on a study of 70 participants.

Participants in the intervention group reported higher Pros scores (p < 0.001) and lower Cons scores (p = 0.008) compared to the control group, indicating that the videos effectively encouraged a more positive attitude towards physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Brain Breaks Video Intervention of Decisional Balance among Malaysians with Type 2 Diabetes Mellitus: A Randomised Controlled Trial. Hidrus, A., Kueh, YC., Norsa'adah, B., et al.[2021]

A systematic review of 47 studies involving over 8000 individuals with prediabetes or diabetes found that while there are some risks associated with increased physical activity, such as musculoskeletal injuries and hypoglycemia, the overall prevalence of severe adverse events is low.

The review supports that increased physical activity is generally safe for individuals with prediabetes and diabetes, and it led to the development of a new risk assessment algorithm to help guide safe exercise practices for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: diabetes mellitus and related comorbidities. Riddell, MC., Burr, J.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8802999/

Exercise/Physical Activity in Individuals with Type 2 Diabetes Resistance exercise training in adults with T2D typically results in 10-15% improvements in strength, bone mineral density, blood pressure, lipid profiles, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2667036423000018

The importance of exercise for glycemic control in type 2 ... Movement throughout the day by breaking up sitting time benefits blood glucose and insulin. Physical activity after meals reduces blood glucose.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6908414/

Physical Activity/Exercise and Diabetes: A Position ... Exercise improves blood glucose control in type 2 diabetes, reduces cardiovascular risk factors, contributes to weight loss, and improves well-being (1,2).

4. journals.physiology.org journals.physiology.org/doi/10.1152/japplphysiol.00484.2024

Low-intensity activity breaks combined with alternate day ... This study demonstrates that combining light-intensity activity breaks throughout the day with structured high-intensity exercise every other day can mitigate ...

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-022-13123-x

Sitting less and moving more for improved metabolic and ... Results from the trial will inform whether a sit less and move more intervention is effective in adults with type 2 diabetes. The findings ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05574426

Efficacy of Movement Breaks in Real-World Settings ... The purpose of this study is to determine the efficacy of performing "exercise snacks" (short movement breaks throughout the day) on various measures of ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pdi.2361

Physical Activity & Exercise for Type 2 Diabetes: Where to Start? Those with T2D are encouraged to engage in a minimum of 150 minutes/week of moderate-intensity physical activity (or 75 minutes/week of vigorous ...