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

Trial Summary

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 data supports the effectiveness of the treatment Movement breaks for Type 2 Diabetes?

Research shows that regular physical activity, including low-intensity exercises and movement breaks, can help manage type 2 diabetes by improving blood sugar control and reducing related health issues. Studies have demonstrated that incorporating physical activity into daily routines can lead to better long-term health outcomes for individuals with type 2 diabetes. ^{1 2 3 4 5}

Is it safe for people with type 2 diabetes to take movement breaks?

Movement breaks, or low-intensity exercise, are generally safe for people with type 2 diabetes if certain precautions are taken. While there is a low risk of mild to severe issues like muscle injuries or low blood sugar, these can be managed with proper guidance and personalized exercise plans. ^{6 7 8 9 10}

How do movement breaks differ from other treatments for type 2 diabetes?

Movement breaks involve short, low-intensity physical activities throughout the day, which can help lower fasting blood sugar levels and reduce daily blood sugar fluctuations. This approach is different from traditional exercise programs that often require longer, more intense sessions, making it a more accessible option for people who find it challenging to commit to regular exercise routines. ^{9 11 12 13 14}

What is the purpose of this trial?

To conduct a randomized crossover trial to determine the acute impact of low-intensity movement breaks on glycemic control in physically inactive individuals living with type 2 diabetes using continuous glucose monitoring.

Research Team

Jonathan Little, PhD

Principal Investigator

University of British Columbia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States 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. [2019]

3. United States 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. [2022]

4. England 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. [2018]

5. France pubmed.ncbi.nlm.nih.gov

Physical activity and type 2 diabetes. Recommandations of the SFD (Francophone Diabetes Society) diabetes and physical activity working group. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Prevention of exercise-related injuries and adverse events in patients with type 2 diabetes. [2013]

7. Canada pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Diet and exercise in type 2 diabetes mellitus. [2019]

9. Canada 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. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Exercise engagement in people with prediabetes--a qualitative study. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Predictors of exercise intervention dropout in sedentary individuals with type 2 diabetes. [2023]

12. Switzerland 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. [2021]

13. England pubmed.ncbi.nlm.nih.gov

The Impact of Burst Exercise on Cardiometabolic Status of Patients Newly Diagnosed With Type 2 Diabetes. [2018]

14. United States 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. [2021]