- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06684912
Acute Effects of Aerobic Exercise on Flow Mediated Slowing and Flow Mediated Dilation in Adults with and Without Type 2 Diabetes (ARM WRESTLING)
Acute Effects of Moderate Intensity Continuous Exercise Versus High-Intensity Interval Exercise on Flow Mediated Slowing and Flow Mediated Dilation in Adults with and Without Type 2 Diabetes
The endothelium is a protective lining of cells inside blood vessels. It keeps blood vessels working smoothly by controlling how wide or narrow your blood vessels are and protecting them from damage. Normally, the endothelium keeps a healthy balance between signals that relax or tighten blood vessels. But with advancing age or certain diseases like diabetes, this balance is disrupted. This can make blood vessels weaker and lead to serious problems in the heart and other organs.
Researchers use a test called brachial flow-mediated dilation (FMD) to check how well blood vessels work. FMD shows how good blood vessels are at making a chemical called nitric oxide (NO), which helps them relax and widen. During the FMD test, researchers reduce blood flow for a short time with a blood pressure cuff, then release it to see how blood vessels respond. They use an ultrasound machine to measure this. While FMD is useful, it has some downsides-it's hard to do right, needs expensive tools, and experts don't always agree on how to analyze the results. A newer method called flow-mediated slowing (FMS) aims to fix these problems. FMS uses pulse wave velocity (PWV) to measure how stiff your blood vessels are. Stiffer vessels mean less nitric oxide and a higher chance of heart problems. After reducing blood flow with a blood pressure cuff and releasing it, healthy people show a drop in PWV (reduction in arterial stiffness), but people with heart failure or high blood pressure do not. Thus, FMS holds promise as it is an easier way to measure blood vessel health.
Exercise training helps keep blood vessels healthy with advancing age. Research has shown that regular aerobic exercise, (running or biking), and strength exercise (lifting weights), can improve how blood vessels work and make them less stiff. This is true even for healthy people. For people with type 2 diabetes, exercise training is even more important to preserve blood vessel health. The intensity of exercise may determine how much blood vessels improve. Research has shown that high-intensity interval training (HIIT)-where you switch between hard exercise and rest-works better than steady, moderate exercise for making blood vessels healthier and less stiff. It is thought that HIIT improves blood vessel health partly by improving how the body uses insulin. Still, not all studies show that training improves blood vessel health in people with type 2 diabetes.
A single session of exercise presents a challenge to blood vessels that allows researchers to understand how exercise over time improves blood vessel health. In addition, studying how blood vessels react to one workout (called the acute exercise model) is helpful because researchers can easily control things like the type of exercise, how hard it is, or how long it lasts. Acute exercise research also helps control other factors, such as nutrition, that may bias results. Thus, acute exercise research is a great method to learn how exercise works in the short term and how it might help in the long run.
Therefore, the present study aimed to determine how FMD and FMS respond after an acute bout of high-intensity interval exercise and moderate continuous exercise in older adults without type 2 diabetes, and also healthy young adults.
The key research questions were:
- Is the FMD and FMS response after an acute bout of exercise dependent on exercise intensity?
- Is the FMD and FMS response after an acute bout of exercise dependent on age and disease status?
All participants were asked to:
Complete two exercise sessions - one moderate- and one high-intensity interval bout on a treadmill. The order of the sessions was randomly assigned, similar to flipping a coin.
FMD and FMS were measured before and after each acute exercise bout in the laboratory.
The researchers compared FMD and FMS responses between exercise intensities (high vs. moderate) and populations (individuals with and without type diabetes).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lisbon, Portugal
- Faculdade de Motricidade Humana - University of Lisbon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Body mass index < 30 kg/m2
- Less than two risk factors for cardiovascular disease (for participants without type diabetes mellitus)
- No electrocardiographic or symptomatic abnormalities on the exercise stress
- Physically active (3-5 days of structured exercise; for participants without type diabetes)
- Glycosylated haemoglobin (HbA1c) levels (≥ 5.7% and bellow 8.0%) or fasting blood glucose ≥126 mg/dL and below 185 mg/dL) - for participants with type 2 diabetes
Exclusion Criteria:
- Cardiovascular disease (e.g., heart failure, ischemic heart disease)
- Orthostatic intolerance
- Thyroid dysfunction
- Mental disease
- Microvascular complications (e.g., neuropathies)
- Renal disease
- Musculoskeletal disease (e.g., sarcopenia, osteoporosis)
- Smoking
- Vasoactive medications (e.g. angiotensin-converting enzyme inhibitors, calcium channel blockers)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: CONTROL
A non-exercise condition.
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Experimental: High intensity interval exercise (HIIE)
The HIIE was comprised of 1 min exercise bouts at 90% of oxygen uptake (V̇O2) reserve interspersed by 1 min active recovery bouts at 60% V̇O2 reserve (1:1).
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The number of bouts of exercise-recovery for each participant was tailored to achieve the desired EE.
For example, a participant with a peak oxygen uptake (V̇O2) peak of 30 mL.kg-1.min-1,
weighing 80 kg, would need 6 bouts to match the target EE, assuming 1L of O2 uptake equals 5 kcal.
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Experimental: Moderate-intensity exercise (MICE)
MICE at 60% V̇O2 reserve with the duration adjusted to each participant so that each participant achieved the target energy expenditure.
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Energy expenditure of exercise conditions (HIIE and MICE) were matched for energy expenditure.
A participant with a V̇O2 peak of 30 mL.kg-1.min-1,
weighing 80 kg, would need 6 bouts to match the target EE, assuming 1L of O2 uptake equals 5 kcal.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Brachial endothelial function
Time Frame: Before and 10, and 60-minutes after acute aerobic exercise
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Brachial artery flow-mediated dilation - ultrasound
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Before and 10, and 60-minutes after acute aerobic exercise
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Brachial artery stiffness
Time Frame: Before and 5, and 60-minutes after acute aerobic exercise
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Brachial artery flow-mediated slowing - ultrasound
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Before and 5, and 60-minutes after acute aerobic exercise
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Central arterial stiffness
Time Frame: Before and 10, and 60-minutes after acute aerobic exercise
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Applanation tonometry - carotid-femoral pulse wave velocity
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Before and 10, and 60-minutes after acute aerobic exercise
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Upper limb arterial stiffness
Time Frame: Before and 10, and 60-minutes after acute aerobic exercise
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Applanation tonometry - carotid-radial pulse wave velocity
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Before and 10, and 60-minutes after acute aerobic exercise
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Lower limb arterial stiffness
Time Frame: Before and 10, and 60-minutes after acute aerobic exercise
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Applanation tonometry - carotid-dorsalis pedis pulse wave velocity
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Before and 10, and 60-minutes after acute aerobic exercise
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Xavier Melo, PhD, Egas Moniz School of Health & Science
Publications and helpful links
General Publications
- Thijssen DHJ, Bruno RM, van Mil ACCM, Holder SM, Faita F, Greyling A, Zock PL, Taddei S, Deanfield JE, Luscher T, Green DJ, Ghiadoni L. Expert consensus and evidence-based recommendations for the assessment of flow-mediated dilation in humans. Eur Heart J. 2019 Aug 7;40(30):2534-2547. doi: 10.1093/eurheartj/ehz350.
- Francois ME, Little JP. The impact of acute high-intensity interval exercise on biomarkers of cardiovascular health in type 2 diabetes. Eur J Appl Physiol. 2017 Aug;117(8):1607-1616. doi: 10.1007/s00421-017-3649-2. Epub 2017 May 31.
- Magalhaes JP, Melo X, Correia IR, Ribeiro RT, Raposo J, Dores H, Bicho M, Sardinha LB. Effects of combined training with different intensities on vascular health in patients with type 2 diabetes: a 1-year randomized controlled trial. Cardiovasc Diabetol. 2019 Mar 18;18(1):34. doi: 10.1186/s12933-019-0840-2.
- Colberg SR, Albright AL, Blissmer BJ, Braun B, Chasan-Taber L, Fernhall B, Regensteiner JG, Rubin RR, Sigal RJ; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: American College of Sports Medicine and the American Diabetes Association: joint position statement. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2010 Dec;42(12):2282-303. doi: 10.1249/MSS.0b013e3181eeb61c.
- Fiuza-Luces C, Santos-Lozano A, Joyner M, Carrera-Bastos P, Picazo O, Zugaza JL, Izquierdo M, Ruilope LM, Lucia A. Exercise benefits in cardiovascular disease: beyond attenuation of traditional risk factors. Nat Rev Cardiol. 2018 Dec;15(12):731-743. doi: 10.1038/s41569-018-0065-1.
- Ashor AW, Lara J, Siervo M, Celis-Morales C, Oggioni C, Jakovljevic DG, Mathers JC. Exercise modalities and endothelial function: a systematic review and dose-response meta-analysis of randomized controlled trials. Sports Med. 2015 Feb;45(2):279-96. doi: 10.1007/s40279-014-0272-9.
- Ellins EA, New KJ, Datta DB, Watkins S, Haralambos K, Rees A, Aled Rees D, Halcox JP. Validation of a new method for non-invasive assessment of vasomotor function. Eur J Prev Cardiol. 2016 Apr;23(6):577-83. doi: 10.1177/2047487315597210. Epub 2015 Jul 24.
- Naka KK, Tweddel AC, Doshi SN, Goodfellow J, Henderson AH. Flow-mediated changes in pulse wave velocity: a new clinical measure of endothelial function. Eur Heart J. 2006 Feb;27(3):302-9. doi: 10.1093/eurheartj/ehi619. Epub 2005 Nov 2.
- Cahill PA, Redmond EM. Vascular endothelium - Gatekeeper of vessel health. Atherosclerosis. 2016 May;248:97-109. doi: 10.1016/j.atherosclerosis.2016.03.007. Epub 2016 Mar 9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARM WRESTLING
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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