High-Intensity Interval Training for Type 2 Diabetes

(FHT HIIT Trial)

Overseen By Michael Fernando, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Pregnant, Myocardial infarction, 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: 3

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment High-Intensity Interval Training for Type 2 Diabetes?

Research shows that high-intensity interval training (HIIT) can improve blood sugar control and heart fitness in people with type 2 diabetes. It is also a time-efficient way to manage risk factors for heart and metabolic diseases, making it a practical option for those who struggle to meet traditional exercise guidelines. ^{1 2 3 4 5}

Is high-intensity interval training (HIIT) generally safe for humans?

HIIT is generally well-tolerated and may offer health benefits, but caution is advised for people with heart and metabolic conditions. They should be stable, have some exercise experience, and be supervised during sessions. No acute injuries were reported in most studies, and adherence rates were high. ^{3 6 7 8 9}

How does high-intensity interval training differ from other treatments for type 2 diabetes?

High-intensity interval training (HIIT) is unique because it can improve blood sugar control and fitness in a shorter time compared to traditional continuous exercise, making it a practical option for those who find it hard to commit to longer workout sessions. ^{3 5 10 11 12}

What is the purpose of this trial?

With the rapid shift to virtual care, this pilot study aims to determine the feasibility of prescribing low-duration, interval-based training through virtual care. If successful, this study will inform a larger randomized control trial to determine if the prescription of low-duration interval-based training improves chronic disease through the measurement of hemoglobin A1C (HbA1C), and weight to a greater extent than the general guideline to aim for 150 minutes of PA weekly.

Eligibility Criteria

This trial is for adults over 18 with type 2 diabetes who can safely exercise and have their doctor's (Dr. Fernando) approval. They must be able to consent and should not be pregnant or have had a heart attack in the last three months.

Inclusion Criteria

Non-pregnant

Deemed capable and safe to exercise by their physician (Dr. Fernando)

I have not had a heart attack in the last three months.

Exclusion Criteria

I do not have type 2 diabetes.

Pregnant

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Data collection at baseline including weight, height, minutes of PA, HbA1C, and medication review

1 week

1 visit (virtual)

Intervention

Participants follow either a high-intensity interval training (HIIT) or population-based physical activity protocol

6 months

Self-directed with virtual support

Follow-up

Participants are monitored for changes in HbA1C, weight, and physical activity at 3-month and 6-month intervals

6 months

2 visits (virtual)

Treatment Details

Interventions

• High-Intensity Interval Training Physical Activity (PA) Advice

Trial Overview The study tests if virtual care can effectively prescribe short, intense workouts to manage type 2 diabetes better than the standard advice of getting at least 150 minutes of physical activity per week.

Participant Groups

Group I: High-Intensity Interval Training Physical Activity (PA) Advice Experimental Treatment 1 Intervention

This PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a High-Intensity-Interval-Training (HIIT) handout (developed based on research from Dr. Martin Gibala) detailing their PA recommendations. Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for a research assistant who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, the research assistant will respond to these over the phone.

Group II: Population-Based Physical Activity (PA) Advice Active Control 1 Intervention

This PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a CSEP handout (page 4\&5 from: http://csep.ca/CMFiles/Guidelines/CSEP_PAGuidelines_0-65plus_en.pdf) detailing their PA recommendations.Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for a research assistant who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, the research assistant will respond to these over the phone.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

East Elgin Family Health Team

Collaborator

Trials

2

Recruited

220+

Findings from Research

Both low volume high intensity interval exercise (HIIE) and extremely low volume sprint interval exercise (SIE) improved aerobic capacity in individuals with type 2 diabetes, with HIIE showing a greater improvement in VO2peak and body fat percentage.

Despite these improvements in exercise capacity, neither HIIE nor SIE led to significant changes in glycemic control (HbA1c), suggesting that longer or more intensive exercise interventions may be necessary to impact blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Time Efficient Exercise Improve Cardiometabolic Risk Factors in Type 2 Diabetes? A Pilot Study. Revdal, A., Hollekim-Strand, SM., Ingul, CB.[2022]

High-intensity training has been shown to significantly improve metabolic parameters in patients with pre-diabetes and type 2 diabetes, highlighting the importance of exercise therapy for glycemic control.

For patients unable to engage in traditional exercise due to complications, non-exercise activity thermogenesis (NEAT) can be beneficial, providing an alternative way to enhance metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Therapy for Patients With Type 2 Diabetes: A Narrative Review. Yanai, H., Adachi, H., Masui, Y., et al.[2020]

A 6-week high-intensity interval training (HIT) program, requiring less than 15 minutes per session, significantly improved key health markers in 189 sedentary adults with pre-existing risk factors for type 2 diabetes, including a 10% increase in fitness levels and a 16% reduction in insulin resistance.

The HIT protocol also effectively lowered mean arterial blood pressure by 3%, demonstrating that this time-efficient exercise regimen can be as effective as longer, traditional exercise programs in managing cardio-metabolic risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Practical and Time-Efficient High-Intensity Interval Training Program Modifies Cardio-Metabolic Risk Factors in Adults with Risk Factors for Type II Diabetes. Phillips, BE., Kelly, BM., Lilja, M., et al.[2019]

A 12-week study involving 15 participants with type 2 diabetes showed that high intensity interval exercise (HI-IE) is as feasible as moderate intensity continuous exercise (MI-CE), with both groups maintaining high adherence rates of over 97%.

Both HI-IE and MI-CE effectively reduced total body fat and trunk fat, but neither intervention significantly changed glycated hemoglobin A1c (HbA1c) levels, indicating limited impact on blood sugar control in participants who were already well-managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of high intensity interval training in type 2 diabetes. Terada, T., Friesen, A., Chahal, BS., et al.[2022]

High-intensity interval training (HIIT) significantly improved glycemic control and cardiorespiratory fitness in patients with type 2 diabetes, showing reductions in body fat, hemoglobin A1c, and increased VO2peak compared to moderate-intensity training (MICT) and no training.

In a systematic review of 13 trials with 345 participants, HIIT led to greater reductions in body weight and body mass index than MICT, indicating that HIIT may be a more effective exercise strategy for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of high-intensity interval training on glycemic control and cardiorespiratory fitness in patients with type 2 diabetes: a systematic review and meta-analysis. Liu, JX., Zhu, L., Li, PJ., et al.[2022]

A systematic review of 11 studies involving 156 clinically stable patients with cardiometabolic diseases found that high-intensity interval exercise (HIIE) can lead to adverse responses in about 8% of individuals, indicating a higher risk compared to moderate-intensity exercise.

It is recommended that patients with cardiometabolic diseases who wish to engage in HIIE should be clinically stable, have prior experience with moderate-intensity exercise, and exercise under supervision to ensure safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Doesn't Kill You Makes You Fitter: A Systematic Review of High-Intensity Interval Exercise for Patients with Cardiovascular and Metabolic Diseases. Levinger, I., Shaw, CS., Stepto, NK., et al.[2022]

High-intensity aerobic interval training (HAIT) significantly improved aerobic fitness, as shown by a 21% increase in VO2max and a reduction in HbA1c by 0.58% in individuals with type 2 diabetes over 12 weeks.

HAIT also led to a reduction in body weight and body mass index, demonstrating its effectiveness in addressing multiple risk factors associated with type 2 diabetes compared to moderate-intensity training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity aerobic interval training improves aerobic fitness and HbA1c among persons diagnosed with type 2 diabetes. Støa, EM., Meling, S., Nyhus, LK., et al.[2022]

High-intensity interval training (HIIT) has been shown to significantly improve various health outcomes, including cardiorespiratory fitness, muscle mass, and mental health indicators like anxiety and depression, across diverse populations, as evidenced by 33 systematic reviews involving both healthy individuals and those with health complications.

HIIT is considered safe, with no reported acute injuries and high adherence rates exceeding 80%, suggesting it is a feasible exercise option for many people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can high-intensity interval training improve physical and mental health outcomes? A meta-review of 33 systematic reviews across the lifespan. Martland, R., Mondelli, V., Gaughran, F., et al.[2023]

A scoping review of 69 studies on high-intensity interval training (HIIT) in older adults found that HIIT protocols are generally well-tolerated and can provide significant health benefits, particularly in improving cardiorespiratory fitness.

Most research has focused on healthy older adults, highlighting a need for larger studies and more investigation into HIIT's effects on older adults with various health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Older Adults: a Scoping Review. Marriott, CFS., Petrella, AFM., Marriott, ECS., et al.[2021]

A 12-week high-intensity interval training (HIIT) program significantly reduced heart rate at the onset and during specific intervals of exercise in patients with type 2 diabetes and hypertension, indicating improved cardiovascular efficiency.

Participants who adhered to the HIIT program experienced a notable decrease in heart rate during exercise intervals, suggesting enhanced cardiovascular recovery, while no significant changes were observed in body mass index or blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiovascular recovery during intermittent exercise in highly-adherent partic pants with hypertension and type 2 diabetes mellitus]. Cano-Montoya, J., Álvarez, C., Martínez, C., et al.[2017]

Sprint interval training (SIT) and combined aerobic + resistance training (COMB) significantly reduced HbA1c levels in participants with type 2 diabetes, with SIT showing a reduction of -1.82% and COMB -1.24% over 10 weeks, compared to no change in the control group.

Both SIT and COMB also led to significant improvements in insulin sensitivity, as indicated by reductions in HOMA-IR, with SIT showing a decrease of -4.89 and COMB -2.90, highlighting their efficacy as exercise interventions for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sprint interval training vs. combined aerobic + resistance training in overweight women with type 2 diabetes. Banitalebi, E., Mardaniyan Ghahfarrokhi, M., Faramarzi, M., et al.[2022]

High-intensity interval training (HIIT) and sprint interval training (SIT) can significantly improve glycemic control in individuals with metabolic syndrome (MetS) and type 2 diabetes (T2D), potentially more effectively than traditional aerobic exercise.

These interval training methods require less time commitment, addressing common barriers to regular exercise, making them a practical option for enhancing glucose metabolism in patients with MetS and T2D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of high-intensity interval training and sprint interval training on peripheral markers of glycemic control in metabolic syndrome and type 2 diabetes. Jiménez-Maldonado, A., García-Suárez, PC., Rentería, I., et al.[2022]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Can Time Efficient Exercise Improve Cardiometabolic Risk Factors in Type 2 Diabetes? A Pilot Study. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Exercise Therapy for Patients With Type 2 Diabetes: A Narrative Review. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Practical and Time-Efficient High-Intensity Interval Training Program Modifies Cardio-Metabolic Risk Factors in Adults with Risk Factors for Type II Diabetes. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of high intensity interval training in type 2 diabetes. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of high-intensity interval training on glycemic control and cardiorespiratory fitness in patients with type 2 diabetes: a systematic review and meta-analysis. [2022]

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

What Doesn't Kill You Makes You Fitter: A Systematic Review of High-Intensity Interval Exercise for Patients with Cardiovascular and Metabolic Diseases. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

High-intensity aerobic interval training improves aerobic fitness and HbA1c among persons diagnosed with type 2 diabetes. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Can high-intensity interval training improve physical and mental health outcomes? A meta-review of 33 systematic reviews across the lifespan. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Older Adults: a Scoping Review. [2021]

10. Chile pubmed.ncbi.nlm.nih.gov

[Cardiovascular recovery during intermittent exercise in highly-adherent partic pants with hypertension and type 2 diabetes mellitus]. [2017]

11. Italy pubmed.ncbi.nlm.nih.gov

Sprint interval training vs. combined aerobic + resistance training in overweight women with type 2 diabetes. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of high-intensity interval training and sprint interval training on peripheral markers of glycemic control in metabolic syndrome and type 2 diabetes. [2022]