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EXERFLOW STUDY:The effects of aerobic and resistance exercise training on vascular endothelial function in people with type 2 diabetes mellitus

In patients with type 2 diabetes mellitus who are sedentary, are aerobic exercise or resistance exercise, different to no exercise (stretching only) in causing change in endothelial function and insulin sensitivity?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000799257
Enrollment
38
Registered
2009-09-15
Start date
2009-09-21
Completion date
2010-10-11
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

People with type 2 diabetes have a higher risk of diseases affecting large blood vessels, such as heart attack, stroke, and blockage to blood flow in the leg, as well as diseases of small blood vessels affecting the eyes, kidneys and nerves. One of the early markers of blood vessel problems is poor function of the blood vessel lining, called the endothelium. Dysfunction of the endothelium predicts cardiovascular events. Exercise is important for management of type 2 diabetes. Currently, people with type 2 diabetes are encouraged to perform moderate intensity aerobic exercise, and if there are no contraindications, muscle-strengthening (resistance) exercise. In terms of the effect on endothelial function, the optimal exercise prescription is not known. This study will examine the effect of resistance training alone and aerobic training alone on endothelial function in people with type 2 diabetes who were previously insufficiently active. By doing this study, we will discover more about how the different types of exercise influence blood vessel function in people with type 2 diabetes.

Interventions

Aerobic exercise for 8 weeks OR resistance exercise for 8 weeks. Participants in the two intervention arms complete either 8 weeks of aerobic exercise or 8 weeks of resistance training. Aerobic exercise consists of 34 minutes of aerobic exercise using a stationary cycle at intensity of 40-70% of heart rate reserve will be completed, followed by 10 minutes of stretching as a cool down/recovery, for three sessions per week for 8 weeks. This intensity is equivalent to the aerobic training guideline

Aerobic exercise for 8 weeks OR resistance exercise for 8 weeks. Participants in the two intervention arms complete either 8 weeks of aerobic exercise or 8 weeks of resistance training. Aerobic exercise consists of 34 minutes of aerobic exercise using a stationary cycle at intensity of 40-70% of heart rate reserve will be completed, followed by 10 minutes of stretching as a cool down/recovery, for three sessions per week for 8 weeks. This intensity is equivalent to the aerobic training guidelines provided by diabetes associationsleading health agencies of with regards to a moderate intensity walk. Heart rate and rating of perceived exertion (RPE) will be monitored periodically throughout the exercise session by the supervising exercise physiologist and used to guide the participant to achieve the prescribed intensity. Resistance exercise will consist of an individualised resistance training program consisting of 6-8 exercises developed from a pool of exercises using pin-loaded weight machines and free-weights.Three sessions per week will be completed consisting of three sets of 8-10 repetitions at 70% one-repetition maximum (1RM) followed by 10 minutes of stretching as a cool down/recovery. The weight will be increased periodically for each muscle group as tolerated once the prescribed number of sets and 10 repetitions can be successfully achieved with appropriate technique in two consecutive sessions. One-repetition maximum testing will be repeated every four weeks to establish a new baseline and to guide the prescription of training intensity within the prescribed range. Exercise intensity will be monitored using heart rate and the RPE scale.

Sponsors

Baker IDI Heart and Diabetes Institute
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

People with established type 2 diabetes (duration > 6 months), treated with diet or oral antihyperglycaemic agents, as monotherapy, dual or triple therapy with metformin, sitagliptin, glitazone or acarbose; (no more than 3 oral agents; stable dose for = 8 weeks), with stable weight over the previous 3 months (< 5% change in body weight), stable glycaemic control for at least the past 8 weeks (no changes to diabetes medication), HbA1c greater or equal to 6.5% and less than or equal to 9.9%.

Exclusion criteria

Exceeding the national recommendations for exercise which are at least 30 mins of moderate-intensity aerobic activity on 5 days of the weeks for at least 3 months and/or at least 20 mins of vigorous-intensity aerobic activity on 3 days of the week for at least 3 mths (60 mins per week). Any strength trainig for 2 or more sessions per week in last 3 months is an exclusion. Body mass index <18.0 or >40.0, seated resting blood pressure > 160 mm Hg systolic of > 95 mm Hg diastolic, pregnancy, anticipated requirement for medications affecting glucose tolerance during trial, renal disease or kidney failure, current smoker, taking medication to lower heart rate (beta blockers), unable to commit to completing the entire protocol, language other than English, known physical activity contraindications, other illness/injury (acute or chronic) leading to physical or medical problems that may limit the ability to perfom the necessary exercise.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026