AgeingUNDER PRESSURENCT07079280
Comparing Vascular Responses to Aerobic Exercise With and Without Blood Flow Restriction in Young and Older Adults
A study testing Low Intensity Aerobic Exercise with Blood Flow Restriction (LIAE+BFR) and High Intensity Interval Exercise (HIIE) in people with Ageing and Blood Flow Restriction (BFR) Training Effects, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
Trial summary
Aging is a major risk factor for cardiovascular disease (CVD), contributing to progressive macrovascular and microvascular dysfunction. Macrovascular impairments, such as arterial stiffening and endothelial dysfunction, reduce nitric oxide (NO) bioavailability, leading to hypertension and impaired blood flow… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ageing, Blood Flow Restriction (BFR) Training Effects
- What is being tested?
- Low Intensity Aerobic Exercise with Blood Flow Restriction (LIAE+BFR) and High Intensity Interval Exercise (HIIE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePortugal
- Study dates
- 6 Oct 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18-30 years and those over 60 years.
Who cannot join
- Past or current history of coronary heart disease, stroke, oncological disease, or major cardiovascular events.
- Individuals who had undergone surgery within the last two months
- Body mass index (BMI) greater than 30 kg/m²
- Declared sleep apnea
- Active kidney or liver disease
- Active tobacco smokers
Show all 9Show fewer
- Sensory impairments
- Neurological or orthopedic functional impairments, musculoskeletal pathologies affecting exercise capacity
- Physically active for more than six months with a weekly activity level of 1,000 MET/min.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Egas Moniz School of Health and Science
Almada, 2829-511
Xavier Melo, PhD, +351212946700, xmelo@egasmoniz.edu.pt
About this study
Official title: Comparison of Acute Micro- and Macrovascular Responses to Aerobic Exercise With and Without Blood Flow Restriction in Young and Older Adults: A Randomized Crossover Trial.
Aging is a major risk factor for cardiovascular disease (CVD), contributing to progressive macrovascular and microvascular dysfunction. Macrovascular impairments, such as arterial stiffening and endothelial dysfunction, reduce nitric oxide (NO) bioavailability, leading to hypertension and impaired blood flow regulation. Microvascular dysfunction exacerbates cardiovascular decline by compromising capillary perfusion and tissue oxygenation, increasing susceptibility to ischemic events. Preserving vascular function is essential for maintaining cardiovascular health in aging populations.
Low-intensity aerobic exercise (LIAE) improves cardiovascular health and mobility, particularly in populations unable to perform high-intensity exercise. However, LIAE alone often fails to induce significant vascular adaptations, such as improved arterial compliance or endothelial function, highlighting the need for optimized interventions.
Read more
Blood Flow Restriction (BFR) enhances vascular adaptations during low-intensity exercise by inducing localized hypoxia, stimulating endothelial function and arterial remodeling. While BFR may transiently increase blood pressure and arterial stiffness, its vascular benefits resemble those of high-intensity exercise at lower workloads. However, research on BFR's acute vascular effects during aerobic exercise in older adults remains limited.
Current studies have focused on perceptual and hemodynamic responses to LIAE+BFR but lack direct assessments of macrovascular (e.g., flow-mediated slowing) and microvascular function. Older adults may exhibit distinct vascular responses, yet data are scarce. This study examines acute vascular responses to LIAE+BFR and high-intensity interval exercise (HIIE) in young and older adults.
Hypothesis:
- BFR combined with LIAE will elicit greater acute microvascular and macrovascular responses in older adults than in younger adults.
- These responses will be comparable to HIIE without BFR, suggesting BFR enhances LIAE's efficacy to high-intensity levels.
- Any transient vascular dysfunction (e.g., increased arterial stiffness) will normalize within 30 minutes post-exercise, supporting safety in aging populations.
Read the detailed description
In this parallel-group crossover randomized trial, young and older adult participants will be randomly assigned to two experimental conditions: LIAE+BFR and HIIE. These two conditions were specifically chosen because they are known to induce similar haemodynamic responses. Each participant will visit the laboratory on three separate occasions, with at least one week between visits allowing recovery and minimizing potential carryover effects.
On Visit 1, participants will be familiarized with the exercise and testing protocols, undergo body composition measurements, and have baseline macrovascular and microvascular function evaluated twice, 30 minutes apart, in a resting condition (control). On Visits 2 and 3, participants will perform the experimental conditions in a simple randomized order, with allocation concealed until arrival at the laboratory. The simple randomization scheme sequence will be generated by Dr. XM using a web-based randomization tool (http://www.randomizer.org/) and placed in sequentially numbered, opaque, sealed envelopes to ensure allocation concealment and minimize bias. Researchers conducting field assessments will remain blinded to group allocation until the day of the first visit.
Each session will begin with 15 minutes of supine rest on a cushioned examination table, followed by baseline assessments of brachial (bSBP) and central blood pressure (cSBP), heart rate (HR), microvascular function using finger photoplethysmography (Vicorder, 80 beats medical, Berlin, Germany)., macrovascular function using FMS, and central PWV (cPWV).
After baseline assessments, participants will engage in one of the randomized aerobic exercise conditions, lasting approximately 30 minutes. The workload will be equalized considering intensity and stimulus time (intensity x duration) and the protocol is directly inspired by a previous study. In the LIAE+BFR condition, participants will walk on a treadmill (Technogym Excite Run, Technogym SpA, Cesena, Italy) for 20 minutes, using a 5 cm × 75 cm pneumatic cuff (Occlusion Cuff Pro®, Occlusion Cuff LLC, 2024) inflated to 1.3 times the individual's ankle SBP (Suga et al., 2012) The intensity will be set between 30-39% of heart rate reserve (HRR), a widely used method for prescribing aerobic exercise intensity (Liguori et al., 2021). In the HIIE condition, participants will perform a 20-minute treadmill-based high-intensity interval training, alternating between 60-seconds high-intensity intervals at 60-89% HRR and 60-second active recovery intervals at 40-50% HRR. Treadmill speed will be adjusted dynamically to maintain target intensities, while the incline remains at 1%. HR, the Modified Borg Rate of Perceived Exertion (RPE) scale, and the Rating of perceived discomfort will be continuously monitored throughout both exercise sessions to ensure adherence to the prescribed intensity levels.
Immediately after exercise, participants will return to the examination table for a 30-minute recovery period, during which brachial blood pressure, heart rate, and micro- and macrovascular function will be reassessed at 5- and 30-minutes post-exercise and compared to resting values. These post-exercise time points aim to characterize the biphasic response of macro- and microvascular function.
All participants will report to the laboratory between 8:00 AM and 12:00 PM, with room temperature controlled between 20-22°C. Participants will be instructed to avoid caffeine and alcohol for 24 hours, fully void before the session, and refrain from vigorous physical activity for 24 hours before each session, including the familiarization session.
All evaluations will be conducted by four trained physiotherapy students per participant (4:1), each with over 30 hours of training in the evaluation and exercise protocols. Throughout all sessions, a certified professional in basic life support (BLS) and automated external defibrillator (AED) use will be present at the clinic.
- Being tested
- Low Intensity Aerobic Exercise with Blood Flow Restriction (LIAE+BFR), High Intensity Interval Exercise (HIIE)
- Keywords
- Aerobic Exercise, Blood Flow Restriction, Microvascular Function, Flow mediated Slowing, Arterial Stiffness, Central Blood Pressure, Young Adults, Older Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity Aerobic Exercise with Blood Flow Restriction (LIAE+BFR)Other
In the LIAE+BFR condition, participants will walk on a treadmill for 20 minutes at 30-40% of heart rate reserve (HRR), with a pneumatic cuff inflated to 1.3 times the individual's ankle systolic blood pressure, using a 5cm wide x 75cm long commercial cuff around each upper thigh.
Treadmill speed will be adjusted dynamically to maintain target intensities, while the incline remains at 1%. Heart Rate, the Modified Borg Rate of Perceived Exertion scale, and the Rating of perceived discomfort will be continuously monitored throughout both exercise sessions to ensure adherence to the prescribed intensity levels.
High Intensity Interval Exercise (HIIE)Other
In the HIIE condition, participants will perform a 20 minutes treadmill-based HIAE, alternating between 60-seconds high-intensity intervals at 60-89% HRR and 60-second active recovery intervals at 40-50% HRR.
Treadmill speed will be adjusted dynamically to maintain target intensities, while the incline remains at 1%. Heart Rate, the Modified Borg Rate of Perceived Exertion scale, and the Rating of perceived discomfort will be continuously monitored throughout both exercise sessions to ensure adherence to the prescribed intensity levels.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise with Blood Flow Restriction | Experimental | Not described Receives: Other: Low Intensity Aerobic Exercise with Blood Flow Restriction (LIAE+BFR) |
| Aerobic Exercise Without Blood Flow Restriction | Active comparator | Not described Receives: Other: High Intensity Interval Exercise (HIIE) |
| No Exercise or Blood Flow Restriction | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in macrovascular function
We will use the slowing of the pulse wave velocity (PWV) recorded between the upper arm and the wrist as an index of macrovascular function. PWV is inversely related to arterial distensibility; a widening of the brachial artery cross-section will cause a drop in post-occlusive PWV. Macrovascular function will be evaluated using EndoFMS (Vicorder, Berlin, Germany), and the response parameters are PWVmin and PWV% change from pre-occlusion values. The percentage change from initial PWV is called FMS. The default cuff placement is a 10 cm brachial cuff on the upper arm and a 7 cm wrist cuff on the selected limb. The test is performed with the patient lying horizontally, the right arm extended at a 60-degree angle, and the hand rotated palm up. After the patient relaxes, the test starts with a target occlusion pressure 30 mmHg above systolic pressure. Brachial PWV is measured between the wrist and upper arm over 10 minutes, with a 5-minute occlusion period.
Measured: At rest and re-evaluated 5- and 30-minutes into recovery following the experimental conditions
Change in central arterial stiffness
To measure arterial stiffness, we will assess carotid-femoral pulse wave velocity (cPWV) using a Vicorder module (Berlin, Germany). Participants will be in a reclined position, with a minimum of 10 minutes of rest. A 100 mm blood pressure cuff will encircle the upper thigh, and a 30 mm partial cuff will be applied around the neck at the level of the carotid arteries, above the thyroid prominence. The direct path length will be measured from the suprasternal angle to the middle of the femoral blood pressure cuff by the same operator. Both cuffs will be simultaneously inflated to 60 mm Hg to capture femoral and carotid waveforms. Continuous recordings will be obtained beat-to-beat for at least 3 minutes. Automated software will determine the wave\'s foot using an intersecting tangent algorithm. The time delay between the foot of the carotid and femoral waveforms will provide the average TT every 3.5 seconds.
Measured: At rest and re-evaluated 5- and 30-minutes into recovery following the exercise condition
Change in blood pressure
The brachial artery pulse waveform obtained oscillometrically, will be analyzed using the Pulse Wave Analysis (PWA) function of the Vicorder® device (Berlin, Germany), and the aortic waveform calculated using a transfer function. This enables calculation of arterial system parameters, including cSBP, augmentation pressure (AugPress), augmentation index (AugInd), central peripheral pressure (cPP), cardiac output, and total peripheral resistance. Initial waves will be omitted, and good-quality consecutive pulse waves will be analyzed.
Measured: At rest and re-evaluated after each set and 5- and 30-minutes into recovery following the exercise condition
Change in microvascular function
Microvascular function will be assessed using EndoCheckPAR (Vicorder, Berlin, Germany). Participants will be in a supine position with their arms comfortably positioned. Changes in the peripheral arterial dilation ratio (PAR) signal to reactive hyperemia (RH) will be measured at the fingertip with photoplethysmographs and an inflating device controlled by a computer algorithm. The RH procedure consists of a 30-second calibration, a 5-minute baseline recording, followed by 5 minutes of blood flow occlusion of the test arm using an upper arm blood pressure cuff inflated to 30 mmHg above the patient's systolic brachial pressure. After cuff deflation, the PAR tracing will be recorded for another 3 minutes. The software automatically normalizes this ratio to the concurrent signal from the contralateral, non-occluded forearm to correct for confounding variables. This ratio is then multiplied with a baseline correction factor to obtain Measured Peak, Max Reference Peak, and Max PAR.
Measured: At rest and re-evaluated 5- and 30-minutes into recovery following the exercise condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start6 Oct 2025 (estimated)
- Primary completion29 May 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AgeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Parallel group crossover randomized trial
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079280
- Sponsor's protocol ID
- UNDER PRESSURE
- Acronym
- UNDER PRESSURE
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained in this study may be provided to qualified researchers with academic interest in vascular responses to aerobic training with blood flow restriction. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Publications
Zhang Y, Chai S, Dai H, Chen X, Meng Z, Ying X. Vascular endothelial function and its response to moderate-intensity aerobic exercise in trained and untrained healthy young men. Sci Rep. 2024 Sep 3;14(1):20450. doi: 10.1038/s41598-024-71471-7.
PubMed 39242762Formiga MF, Fay R, Hutchinson S, Locandro N, Ceballos A, Lesh A, Buscheck J, Meanor J, Owens JG, Cahalin LP. EFFECT OF AEROBIC EXERCISE TRAINING WITH AND WITHOUT BLOOD FLOW RESTRICTION ON AEROBIC CAPACITY IN HEALTHY YOUNG ADULTS: A SYSTEMATIC REVIEW WITH META-ANALYSIS. Int J Sports Phys Ther. 2020 Apr;15(2):175-187.
PubMed 32269850Chua MT, Sim A, Burns SF. Acute and Chronic Effects of Blood Flow Restricted High-Intensity Interval Training: A Systematic Review. Sports Med Open. 2022 Sep 30;8(1):122. doi: 10.1186/s40798-022-00506-y.
PubMed 36178530Bai X, Soh KG, Omar Dev RD, Talib O, Xiao W, Soh KL, Ong SL, Zhao C, Galeru O, Casaru C. Aerobic Exercise Combination Intervention to Improve Physical Performance Among the Elderly: A Systematic Review. Front Physiol. 2022 Jan 4;12:798068. doi: 10.3389/fphys.2021.798068. eCollection 2021.
PubMed 35058805Thomas HJ, Scott BR, Peiffer JJ. Acute physiological responses to low-intensity blood flow restriction cycling. J Sci Med Sport. 2018 Sep;21(9):969-974. doi: 10.1016/j.jsams.2018.01.013. Epub 2018 Apr 9.
PubMed 29650336Staunton CA, May AK, Brandner CR, Warmington SA. Haemodynamics of aerobic and resistance blood flow restriction exercise in young and older adults. Eur J Appl Physiol. 2015 Nov;115(11):2293-302. doi: 10.1007/s00421-015-3213-x. Epub 2015 Jul 4.
PubMed 26142277Barili A, Corralo VDS, Cardoso AM, Manica A, Bonadiman BDSR, Bagatini MD, Da Silva-Grigoletto ME, de Oliveira GG, De Sa CA. Acute responses of hemodynamic and oxidative stress parameters to aerobic exercise with blood flow restriction in hypertensive elderly women. Mol Biol Rep. 2018 Oct;45(5):1099-1109. doi: 10.1007/s11033-018-4261-1. Epub 2018 Jul 20.
PubMed 30030775de Queiros VS, Rolnick N, Sabag A, Wilde P, Pecanha T, Aniceto RR, Rocha RFC, Delgado DZ, de Araujo Tinoco Cabral BG, Dantas PMS. Effect of High-Intensity Interval Exercise versus Continuous Low-Intensity Aerobic Exercise with Blood Flow Restriction on Psychophysiological Responses: A Randomized Crossover Study. J Sports Sci Med. 2024 Mar 1;23(1):114-125. doi: 10.52082/jssm.2024.114. eCollection 2024 Mar.
PubMed 38455431
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Acute Micro- and Macrovascular Responses to Aerobic Exercise With and Without Blood Flow Restriction in Young and Older Adults: A Randomized Crossover Trial.
- ClinicalTrials.gov ID
- NCT07079280
- Acronym / sponsor ID
- UNDER PRESSURE / UNDER PRESSURE
- Keywords
- Aerobic Exercise, Blood Flow Restriction, Microvascular Function, Flow mediated Slowing, Arterial Stiffness, Central Blood Pressure, Young Adults, Older Adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Study start
- 6 Oct 2025 (estimated)
- Primary completion
- 29 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aging is a major risk factor for cardiovascular disease (CVD), contributing to progressive macrovascular and microvascular dysfunction. Macrovascular impairments, such as arterial stiffening and endothelial dysfunction, reduce nitric oxide (NO) bioavailability, leading to hypertension and impaired blood flow regulation. Microvascular dysfunction exacerbates cardiovascular decline by compromising capillary perfusion and tissue oxygenation, increasing susceptibility to ischemic events. Preserving vascular function is essential for maintaining cardiovascular health in aging populations.
Low-intensity aerobic exercise (LIAE) improves cardiovascular health and mobility, particularly in populations unable to perform high-intensity exercise. However, LIAE alone often fails to induce significant vascular adaptations, such as improved arterial compliance or endothelial function, highlighting the need for optimized interventions.
Blood Flow Restriction (BFR) enhances vascular adaptations during low-intensity exercise by inducing localized hypoxia, stimulating endothelial function and arterial remodeling. While BFR may transiently increase blood pressure and arterial stiffness, its vascular benefits resemble those of high-intensity exercise at lower workloads. However, research on BFR's acute vascular effects during aerobic exercise in older adults remains limited.
Current studies have focused on perceptual and hemodynamic responses to LIAE+BFR but lack direct assessments of macrovascular (e.g., flow-mediated slowing) and microvascular function. Older adults may exhibit distinct vascular responses, yet data are scarce. This study examines acute vascular responses to LIAE+BFR and high-intensity interval exercise (HIIE) in young and older adults.
Hypothesis:
- BFR combined with LIAE will elicit greater acute microvascular and macrovascular responses in older adults than in younger adults.
- These responses will be comparable to HIIE without BFR, suggesting BFR enhances LIAE's efficacy to high-intensity levels.
- Any transient vascular dysfunction (e.g., increased arterial stiffness) will normalize within 30 minutes post-exercise, supporting safety in aging populations.
Detailed description
In this parallel-group crossover randomized trial, young and older adult participants will be randomly assigned to two experimental conditions: LIAE+BFR and HIIE. These two conditions were specifically chosen because they are known to induce similar haemodynamic responses. Each participant will visit the laboratory on three separate occasions, with at least one week between visits allowing recovery and minimizing potential carryover effects.
On Visit 1, participants will be familiarized with the exercise and testing protocols, undergo body composition measurements, and have baseline macrovascular and microvascular function evaluated twice, 30 minutes apart, in a resting condition (control). On Visits 2 and 3, participants will perform the experimental conditions in a simple randomized order, with allocation concealed until arrival at the laboratory. The simple randomization scheme sequence will be generated by Dr. XM using a web-based randomization tool (http://www.randomizer.org/) and placed in sequentially numbered, opaque, sealed envelopes to ensure allocation concealment and minimize bias. Researchers conducting field assessments will remain blinded to group allocation until the day of the first visit.
Each session will begin with 15 minutes of supine rest on a cushioned examination table, followed by baseline assessments of brachial (bSBP) and central blood pressure (cSBP), heart rate (HR), microvascular function using finger photoplethysmography (Vicorder, 80 beats medical, Berlin, Germany)., macrovascular function using FMS, and central PWV (cPWV).
After baseline assessments, participants will engage in one of the randomized aerobic exercise conditions, lasting approximately 30 minutes. The workload will be equalized considering intensity and stimulus time (intensity x duration) and the protocol is directly inspired by a previous study. In the LIAE+BFR condition, participants will walk on a treadmill (Technogym Excite Run, Technogym SpA, Cesena, Italy) for 20 minutes, using a 5 cm × 75 cm pneumatic cuff (Occlusion Cuff Pro®, Occlusion Cuff LLC, 2024) inflated to 1.3 times the individual's ankle SBP (Suga et al., 2012) The intensity will be set between 30-39% of heart rate reserve (HRR), a widely used method for prescribing aerobic exercise intensity (Liguori et al., 2021). In the HIIE condition, participants will perform a 20-minute treadmill-based high-intensity interval training, alternating between 60-seconds high-intensity intervals at 60-89% HRR and 60-second active recovery intervals at 40-50% HRR. Treadmill speed will be adjusted dynamically to maintain target intensities, while the incline remains at 1%. HR, the Modified Borg Rate of Perceived Exertion (RPE) scale, and the Rating of perceived discomfort will be continuously monitored throughout both exercise sessions to ensure adherence to the prescribed intensity levels.
Immediately after exercise, participants will return to the examination table for a 30-minute recovery period, during which brachial blood pressure, heart rate, and micro- and macrovascular function will be reassessed at 5- and 30-minutes post-exercise and compared to resting values. These post-exercise time points aim to characterize the biphasic response of macro- and microvascular function.
All participants will report to the laboratory between 8:00 AM and 12:00 PM, with room temperature controlled between 20-22°C. Participants will be instructed to avoid caffeine and alcohol for 24 hours, fully void before the session, and refrain from vigorous physical activity for 24 hours before each session, including the familiarization session.
All evaluations will be conducted by four trained physiotherapy students per participant (4:1), each with over 30 hours of training in the evaluation and exercise protocols. Throughout all sessions, a certified professional in basic life support (BLS) and automated external defibrillator (AED) use will be present at the clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel group crossover randomized trial
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise with Blood Flow Restriction | Experimental | Other: Low Intensity Aerobic Exercise with Blood Flow Restriction (LIAE+BFR) |
| Aerobic Exercise Without Blood Flow Restriction | Active comparator | Other: High Intensity Interval Exercise (HIIE) |
| No Exercise or Blood Flow Restriction | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged between 18-30 years and those over 60 years.
Key exclusion criteria (9 listed)
- Past or current history of coronary heart disease, stroke, oncological disease, or major cardiovascular events.
- Individuals who had undergone surgery within the last two months
- Body mass index (BMI) greater than 30 kg/m²
- Declared sleep apnea
- Active kidney or liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Intensity Aerobic Exercise with Blood Flow Restriction (LIAE+BFR)In the LIAE+BFR condition, participants will walk on a treadmill for 20 minutes at 30-40% of heart rate reserve (HRR), with a pneumatic cuff inflated to 1.3 times the individual's ankle systolic blood pressure, using a 5cm wide x 75cm long commercial cuff around each upper thigh. Treadmill speed will be adjusted dynamically to maintain target intensities, while the incline remains at 1%. Heart Rate, the Modified Borg Rate of Perceived Exertion scale, and the Rating of perceived discomfort will be continuously monitored throughout both exercise sessions to ensure adherence to the prescribed intensity levels. | Other | Aerobic Exercise with Blood Flow Restriction |
| High Intensity Interval Exercise (HIIE)In the HIIE condition, participants will perform a 20 minutes treadmill-based HIAE, alternating between 60-seconds high-intensity intervals at 60-89% HRR and 60-second active recovery intervals at 40-50% HRR. Treadmill speed will be adjusted dynamically to maintain target intensities, while the incline remains at 1%. Heart Rate, the Modified Borg Rate of Perceived Exertion scale, and the Rating of perceived discomfort will be continuously monitored throughout both exercise sessions to ensure adherence to the prescribed intensity levels. | Other | Aerobic Exercise Without Blood Flow Restriction |
Primary outcome
Change in macrovascular function
Time frame: At rest and re-evaluated 5- and 30-minutes into recovery following the experimental conditions
We will use the slowing of the pulse wave velocity (PWV) recorded between the upper arm and the wrist as an index of macrovascular function. PWV is inversely related to arterial distensibility; a widening of the brachial artery cross-section will cause a drop in post-occlusive PWV. Macrovascular function will be evaluated using EndoFMS (Vicorder, Berlin, Germany), and the response parameters are PWVmin and PWV% change from pre-occlusion values. The percentage change from initial PWV is called FMS. The default cuff placement is a 10 cm brachial cuff on the upper arm and a 7 cm wrist cuff on the selected limb. The test is performed with the patient lying horizontally, the right arm extended at a 60-degree angle, and the hand rotated palm up. After the patient relaxes, the test starts with a target occlusion pressure 30 mmHg above systolic pressure. Brachial PWV is measured between the wrist and upper arm over 10 minutes, with a 5-minute occlusion period.
Change in central arterial stiffness
Time frame: At rest and re-evaluated 5- and 30-minutes into recovery following the exercise condition
To measure arterial stiffness, we will assess carotid-femoral pulse wave velocity (cPWV) using a Vicorder module (Berlin, Germany). Participants will be in a reclined position, with a minimum of 10 minutes of rest. A 100 mm blood pressure cuff will encircle the upper thigh, and a 30 mm partial cuff will be applied around the neck at the level of the carotid arteries, above the thyroid prominence. The direct path length will be measured from the suprasternal angle to the middle of the femoral blood pressure cuff by the same operator. Both cuffs will be simultaneously inflated to 60 mm Hg to capture femoral and carotid waveforms. Continuous recordings will be obtained beat-to-beat for at least 3 minutes. Automated software will determine the wave\'s foot using an intersecting tangent algorithm. The time delay between the foot of the carotid and femoral waveforms will provide the average TT every 3.5 seconds.
Change in blood pressure
Time frame: At rest and re-evaluated after each set and 5- and 30-minutes into recovery following the exercise condition
The brachial artery pulse waveform obtained oscillometrically, will be analyzed using the Pulse Wave Analysis (PWA) function of the Vicorder® device (Berlin, Germany), and the aortic waveform calculated using a transfer function. This enables calculation of arterial system parameters, including cSBP, augmentation pressure (AugPress), augmentation index (AugInd), central peripheral pressure (cPP), cardiac output, and total peripheral resistance. Initial waves will be omitted, and good-quality consecutive pulse waves will be analyzed.
Change in microvascular function
Time frame: At rest and re-evaluated 5- and 30-minutes into recovery following the exercise condition
Microvascular function will be assessed using EndoCheckPAR (Vicorder, Berlin, Germany). Participants will be in a supine position with their arms comfortably positioned. Changes in the peripheral arterial dilation ratio (PAR) signal to reactive hyperemia (RH) will be measured at the fingertip with photoplethysmographs and an inflating device controlled by a computer algorithm. The RH procedure consists of a 30-second calibration, a 5-minute baseline recording, followed by 5 minutes of blood flow occlusion of the test arm using an upper arm blood pressure cuff inflated to 30 mmHg above the patient's systolic brachial pressure. After cuff deflation, the PAR tracing will be recorded for another 3 minutes. The software automatically normalizes this ratio to the concurrent signal from the contralateral, non-occluded forearm to correct for confounding variables. This ratio is then multiplied with a baseline correction factor to obtain Measured Peak, Max Reference Peak, and Max PAR.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Background: PubMed 39242762Zhang Y, Chai S, Dai H, Chen X, Meng Z, Ying X. Vascular endothelial function and its response to moderate-intensity aerobic exercise in trained and untrained healthy young men. Sci Rep. 2024 Sep 3;14(1):20450. doi: 10.1038/s41598-024-71471-7.
- Background: PubMed 32269850Formiga MF, Fay R, Hutchinson S, Locandro N, Ceballos A, Lesh A, Buscheck J, Meanor J, Owens JG, Cahalin LP. EFFECT OF AEROBIC EXERCISE TRAINING WITH AND WITHOUT BLOOD FLOW RESTRICTION ON AEROBIC CAPACITY IN HEALTHY YOUNG ADULTS: A SYSTEMATIC REVIEW WITH META-ANALYSIS. Int J Sports Phys Ther. 2020 Apr;15(2):175-187.
- Background: PubMed 36178530Chua MT, Sim A, Burns SF. Acute and Chronic Effects of Blood Flow Restricted High-Intensity Interval Training: A Systematic Review. Sports Med Open. 2022 Sep 30;8(1):122. doi: 10.1186/s40798-022-00506-y.
- Background: PubMed 35058805Bai X, Soh KG, Omar Dev RD, Talib O, Xiao W, Soh KL, Ong SL, Zhao C, Galeru O, Casaru C. Aerobic Exercise Combination Intervention to Improve Physical Performance Among the Elderly: A Systematic Review. Front Physiol. 2022 Jan 4;12:798068. doi: 10.3389/fphys.2021.798068. eCollection 2021.
- Results publication: PubMed 29650336Thomas HJ, Scott BR, Peiffer JJ. Acute physiological responses to low-intensity blood flow restriction cycling. J Sci Med Sport. 2018 Sep;21(9):969-974. doi: 10.1016/j.jsams.2018.01.013. Epub 2018 Apr 9.
- Results publication: PubMed 26142277Staunton CA, May AK, Brandner CR, Warmington SA. Haemodynamics of aerobic and resistance blood flow restriction exercise in young and older adults. Eur J Appl Physiol. 2015 Nov;115(11):2293-302. doi: 10.1007/s00421-015-3213-x. Epub 2015 Jul 4.
- Results publication: PubMed 30030775Barili A, Corralo VDS, Cardoso AM, Manica A, Bonadiman BDSR, Bagatini MD, Da Silva-Grigoletto ME, de Oliveira GG, De Sa CA. Acute responses of hemodynamic and oxidative stress parameters to aerobic exercise with blood flow restriction in hypertensive elderly women. Mol Biol Rep. 2018 Oct;45(5):1099-1109. doi: 10.1007/s11033-018-4261-1. Epub 2018 Jul 20.
- Results publication: PubMed 38455431de Queiros VS, Rolnick N, Sabag A, Wilde P, Pecanha T, Aniceto RR, Rocha RFC, Delgado DZ, de Araujo Tinoco Cabral BG, Dantas PMS. Effect of High-Intensity Interval Exercise versus Continuous Low-Intensity Aerobic Exercise with Blood Flow Restriction on Psychophysiological Responses: A Randomized Crossover Study. J Sports Sci Med. 2024 Mar 1;23(1):114-125. doi: 10.52082/jssm.2024.114. eCollection 2024 Mar.
- Individual participant dataSharing planned: Yes. Data obtained in this study may be provided to qualified researchers with academic interest in vascular responses to aerobic training with blood flow restriction. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity Aerobic Exercise with Blood Flow Restriction (LIAE+BFR) and High Intensity Interval Exercise (HIIE) in people with Ageing and Blood Flow Restriction (BFR) Training Effects, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier Melo, PhD (+351 212946700, xmelo@egasmoniz.edu.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in macrovascular function (time frame: At rest and re-evaluated 5- and 30-minutes into recovery following the experimental conditions). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07079280, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.