Comparing Vascular Responses to Aerobic Exercise With and Without Blood Flow Restriction in Young and Older Adults

NCT07079280 | Not Yet Recruiting DMC

• 1 other identifier: UNDER PRESSURE
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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 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:

1. 1.BFR combined with LIAE will elicit greater acute microvascular and macrovascular responses in older adults than in younger adults.
2. 2.These responses will be comparable to HIIE without BFR, suggesting BFR enhances LIAE's efficacy to high-intensity levels.
3. 3.Any transient vascular dysfunction (e.g., increased arterial stiffness) will normalize within 30 minutes post-exercise, supporting safety in aging populations.

Conditions

Ageing; Blood Flow Restriction (BFR) Training Effects

Keywords

Aerobic Exercise; Blood Flow Restriction; Microvascular Function; Flow mediated Slowing; Arterial Stiffness; Central Blood Pressure; Young Adults; Older Adults

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  At rest and re-evaluated 5- and 30-minutes into recovery following the exercise condition

Study Arms (3)

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

Interventions

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.

Aerobic Exercise with Blood Flow Restriction

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.

Aerobic Exercise Without Blood Flow Restriction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18-30 years and those over 60 years.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead

Study Sites (1)

Egas Moniz School of Health and Science

Almada, 2829-511, Portugal

Location

Related Publications (8)

• 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.

  PMID: 39242762 BACKGROUND

• Thomas 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.

  PMID: 29650336 BACKGROUND

• Staunton 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.

  PMID: 26142277 BACKGROUND

• Formiga 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.

  PMID: 32269850 BACKGROUND

• Chua 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.

  PMID: 36178530 BACKGROUND

• Bai 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.

  PMID: 35058805 BACKGROUND

• Barili 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.

  PMID: 30030775 BACKGROUND

• de 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.

  PMID: 38455431 BACKGROUND

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Xavier Melo, PhD

CONTACT

+351 212946700; xmelo@egasmoniz.edu.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcomes will be assessed by the same experts in every time point. Participants and evaluators will be blinded until arrival of the participant for the fist experimental condition.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group crossover randomized trial

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 23, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact xmelo@egasmoniz.edu.pt

Locations

PT (1)