Blood PressureNCT06529068
Cardiovascular Response to Isometric BFR Exercise
A study testing Isometric handgrip exercise, Isometric handgrip exercise with a narrow-elastic band and Isometric handgrip exercise with a wide-rigid cuff in people with Blood Pressure, run by Hirofumi Tanaka at 1 site in United States.
Trial summary
The goal of this interventional study is to evaluate the acute impact of isometric blood flow restriction (BFR) exercise on blood pressure and other cardiovascular functions in healthy young adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Isometric handgrip exercise, Isometric handgrip exercise with a narrow-elastic band and Isometric handgrip exercise with a wide-rigid cuff
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently healthy young adults aged between 18 - 40 years old and signed the informed consent.
Who cannot join
- Abnormal clotting times
- Acid-base imbalance/acidosis
- Arterial calcification
- Atherosclerotic vessels
- Cardiopulmonary conditions
- Diabetes
Show all 33Show fewer
- Dialysis/central venous access
- General/local infection
- High intracranial pressure
- Hip, pelvis, or femur fracture
- History of venous thromboembolism
- Hypertension
- Immobility for greater than 48 hours in the past month
- Immobilizing cast
- Implanted medical device
- Lymphectomies
- Obesity
- Open fracture
- Open or unhealed soft tissue injuries
- Paralysis
- Peripheral vascular disease
- Pregnancy/postpartum
- Prior revascularization
- Renal compromise
- Severe crush injuries
- Sickle cell trait/anemia
- Skin grafts
- Stroke
- Temporary nerve damage
- Thrombophilia
- Tumor/cancer
- Varicose veins
- Vascular grafting
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Aging Research Laboratory
Austin, Texas, 78712-1415
About this study
Official title: Blood Pressure Responses to Isometric Blood Flow Restriction Exercise
The goal of this interventional study is to evaluate the acute impact of isometric blood flow restriction (BFR) exercise on blood pressure and other cardiovascular functions in healthy young adult volunteers. The main question it aims to answer is:
The investigators hypothesize that isometric BFR exercise with a wide-rigid cuff would lead to greater blood pressure and other cardiovascular responses and that these cardiovascular responses would be greater under isometric BFR exercise with narrow-elastic bands compared with the control condition (no cuff).
Participants will perform isometric exercises in 3 laboratory visits with different exercise conditions) no cuff control 2) BFR with wide-rigid cuff 3) BFR with narrow-elastic band.
- Conditions
- Blood Pressure
- Being tested
- Isometric handgrip exercise, Isometric handgrip exercise with a narrow-elastic band, Isometric handgrip exercise with a wide-rigid cuff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric handgrip exerciseBehavioural
The participants will perform isometric handgrip exercises without blood flow restriction.
Isometric handgrip exercise with a narrow-elastic bandBehavioural
The participants will perform isometric handgrip exercises with blood flow restriction using a narrow-elastic band.
Isometric handgrip exercise with a wide-rigid cuffBehavioural
The participants will perform isometric handgrip exercises with blood flow restriction using a wide-rigid cuff.
| Study group | Role | What they receive |
|---|---|---|
| Isometric exercise without BFR cuff (control) | Active comparator | Not described Receives: Behavioral: Isometric handgrip exercise |
| Isometric exercise with narrow-elastic BFR band | Experimental | Not described Receives: Behavioral: Isometric handgrip exercise with a narrow-elastic band |
| Isometric exercise with wide-rigid BFR cuff | Experimental | Not described Receives: Behavioral: Isometric handgrip exercise with a wide-rigid cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure and diastolic blood pressure
Beat-by-beat (both systolic and diastolic blood pressure) blood pressure before, during, and after exercise
Measured: 20 minutes
Brachial artery diameter evaluated by an ultrasound machine
Brachial artery diameter will be measured by an ultrasound machine to calculate flow-mediated dilation (FMD)
Measured: Before and 20 minutes after exercise
Heart rate
Monitor heart rate continuously before, during, and after exercise
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start2 Dec 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hirofumi Tanaka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hirofumi Tanaka, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529068
- Sponsor's protocol ID
- STUDY00006378
- Status last verified
- Jun 2025
- First submitted
- 18 Jul 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lind AR. Cardiovascular responses to static exercise. (Isometrics, anyone?). Circulation. 1970 Feb;41(2):173-6. doi: 10.1161/01.cir.41.2.173. No abstract available.
PubMed 5412979Domingos E, Polito MD. Blood pressure response between resistance exercise with and without blood flow restriction: A systematic review and meta-analysis. Life Sci. 2018 Sep 15;209:122-131. doi: 10.1016/j.lfs.2018.08.006. Epub 2018 Aug 4.
PubMed 30086274Bond CW, Hackney KJ, Brown SL, Noonan BC. Blood Flow Restriction Resistance Exercise as a Rehabilitation Modality Following Orthopaedic Surgery: A Review of Venous Thromboembolism Risk. J Orthop Sports Phys Ther. 2019 Jan;49(1):17-27. doi: 10.2519/jospt.2019.8375. Epub 2018 Sep 12.
PubMed 30208794Mannozzi J, Al-Hassan MH, Kaur J, Lessanework B, Alvarez A, Massoud L, Aoun K, Spranger M, O'Leary DS. Blood flow restriction training activates the muscle metaboreflex during low-intensity sustained exercise. J Appl Physiol (1985). 2023 Aug 1;135(2):260-270. doi: 10.1152/japplphysiol.00274.2023. Epub 2023 Jun 22.
PubMed 37348015Song JS, Yamada Y, Wong V, Bell ZW, Spitz RW, Abe T, Loenneke JP. Hypoalgesia following isometric handgrip exercise with and without blood flow restriction is not mediated by discomfort nor changes in systolic blood pressure. J Sports Sci. 2022 Mar;40(5):518-526. doi: 10.1080/02640414.2021.2003569. Epub 2021 Nov 25.
PubMed 34823439Renzi CP, Tanaka H, Sugawara J. Effects of leg blood flow restriction during walking on cardiovascular function. Med Sci Sports Exerc. 2010 Apr;42(4):726-32. doi: 10.1249/MSS.0b013e3181bdb454.
PubMed 19952840Early KS, Rockhill M, Bryan A, Tyo B, Buuck D, McGinty J. EFFECT OF BLOOD FLOW RESTRICTION TRAINING ON MUSCULAR PERFORMANCE, PAIN AND VASCULAR FUNCTION. Int J Sports Phys Ther. 2020 Dec;15(6):892-900. doi: 10.26603/ijspt20200892.
PubMed 33344005Credeur DP, Hollis BC, Welsch MA. Effects of handgrip training with venous restriction on brachial artery vasodilation. Med Sci Sports Exerc. 2010 Jul;42(7):1296-302. doi: 10.1249/MSS.0b013e3181ca7b06.
PubMed 20019641Schneider AC, Hughes WE, Ueda K, Bock JM, Casey DP. Reduced blood pressure responsiveness to skeletal muscle metaboreflex activation in older adults following inorganic nitrate supplementation. Nitric Oxide. 2018 Aug 1;78:81-88. doi: 10.1016/j.niox.2018.05.010. Epub 2018 Jun 1.
PubMed 29864505
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Responses to Isometric Blood Flow Restriction Exercise
- ClinicalTrials.gov ID
- NCT06529068
- Acronym / sponsor ID
- STUDY00006378
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hirofumi TanakaUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 31 Jul 2024 (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.
The goal of this interventional study is to evaluate the acute impact of isometric blood flow restriction (BFR) exercise on blood pressure and other cardiovascular functions in healthy young adult volunteers. The main question it aims to answer is:
The investigators hypothesize that isometric BFR exercise with a wide-rigid cuff would lead to greater blood pressure and other cardiovascular responses and that these cardiovascular responses would be greater under isometric BFR exercise with narrow-elastic bands compared with the control condition (no cuff).
Participants will perform isometric exercises in 3 laboratory visits with different exercise conditions) no cuff control 2) BFR with wide-rigid cuff 3) BFR with narrow-elastic band.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isometric exercise without BFR cuff (control) | Active comparator | Behavioral: Isometric handgrip exercise |
| Isometric exercise with narrow-elastic BFR band | Experimental | Behavioral: Isometric handgrip exercise with a narrow-elastic band |
| Isometric exercise with wide-rigid BFR cuff | Experimental | Behavioral: Isometric handgrip exercise with a wide-rigid cuff |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Apparently healthy young adults aged between 18 - 40 years old and signed the informed consent.
Key exclusion criteria (33 listed)
- Abnormal clotting times
- Acid-base imbalance/acidosis
- Arterial calcification
- Atherosclerotic vessels
- Cardiopulmonary conditions
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 |
|---|---|---|
| Isometric handgrip exerciseThe participants will perform isometric handgrip exercises without blood flow restriction. | Behavioural | Isometric exercise without BFR cuff (control) |
| Isometric handgrip exercise with a narrow-elastic bandThe participants will perform isometric handgrip exercises with blood flow restriction using a narrow-elastic band. | Behavioural | Isometric exercise with narrow-elastic BFR band |
| Isometric handgrip exercise with a wide-rigid cuffThe participants will perform isometric handgrip exercises with blood flow restriction using a wide-rigid cuff. | Behavioural | Isometric exercise with wide-rigid BFR cuff |
Primary outcome
Systolic blood pressure and diastolic blood pressure
Time frame: 20 minutes
Beat-by-beat (both systolic and diastolic blood pressure) blood pressure before, during, and after exercise
Brachial artery diameter evaluated by an ultrasound machine
Time frame: Before and 20 minutes after exercise
Brachial artery diameter will be measured by an ultrasound machine to calculate flow-mediated dilation (FMD)
Heart rate
Time frame: 20 minutes
Monitor heart rate continuously before, during, and after exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 5412979Lind AR. Cardiovascular responses to static exercise. (Isometrics, anyone?). Circulation. 1970 Feb;41(2):173-6. doi: 10.1161/01.cir.41.2.173. No abstract available.
- Background: PubMed 30086274Domingos E, Polito MD. Blood pressure response between resistance exercise with and without blood flow restriction: A systematic review and meta-analysis. Life Sci. 2018 Sep 15;209:122-131. doi: 10.1016/j.lfs.2018.08.006. Epub 2018 Aug 4.
- Background: PubMed 30208794Bond CW, Hackney KJ, Brown SL, Noonan BC. Blood Flow Restriction Resistance Exercise as a Rehabilitation Modality Following Orthopaedic Surgery: A Review of Venous Thromboembolism Risk. J Orthop Sports Phys Ther. 2019 Jan;49(1):17-27. doi: 10.2519/jospt.2019.8375. Epub 2018 Sep 12.
- Background: PubMed 37348015Mannozzi J, Al-Hassan MH, Kaur J, Lessanework B, Alvarez A, Massoud L, Aoun K, Spranger M, O'Leary DS. Blood flow restriction training activates the muscle metaboreflex during low-intensity sustained exercise. J Appl Physiol (1985). 2023 Aug 1;135(2):260-270. doi: 10.1152/japplphysiol.00274.2023. Epub 2023 Jun 22.
- Background: PubMed 34823439Song JS, Yamada Y, Wong V, Bell ZW, Spitz RW, Abe T, Loenneke JP. Hypoalgesia following isometric handgrip exercise with and without blood flow restriction is not mediated by discomfort nor changes in systolic blood pressure. J Sports Sci. 2022 Mar;40(5):518-526. doi: 10.1080/02640414.2021.2003569. Epub 2021 Nov 25.
- Background: PubMed 19952840Renzi CP, Tanaka H, Sugawara J. Effects of leg blood flow restriction during walking on cardiovascular function. Med Sci Sports Exerc. 2010 Apr;42(4):726-32. doi: 10.1249/MSS.0b013e3181bdb454.
- Background: PubMed 33344005Early KS, Rockhill M, Bryan A, Tyo B, Buuck D, McGinty J. EFFECT OF BLOOD FLOW RESTRICTION TRAINING ON MUSCULAR PERFORMANCE, PAIN AND VASCULAR FUNCTION. Int J Sports Phys Ther. 2020 Dec;15(6):892-900. doi: 10.26603/ijspt20200892.
- Background: PubMed 20019641Credeur DP, Hollis BC, Welsch MA. Effects of handgrip training with venous restriction on brachial artery vasodilation. Med Sci Sports Exerc. 2010 Jul;42(7):1296-302. doi: 10.1249/MSS.0b013e3181ca7b06.
- Background: PubMed 29864505Schneider AC, Hughes WE, Ueda K, Bock JM, Casey DP. Reduced blood pressure responsiveness to skeletal muscle metaboreflex activation in older adults following inorganic nitrate supplementation. Nitric Oxide. 2018 Aug 1;78:81-88. doi: 10.1016/j.niox.2018.05.010. Epub 2018 Jun 1.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric handgrip exercise, Isometric handgrip exercise with a narrow-elastic band and Isometric handgrip exercise with a wide-rigid cuff in people with Blood Pressure, run by Hirofumi Tanaka at 1 site in United States.
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 33 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: finished, as of the sponsor's last update on 10 Jun 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure and diastolic blood pressure (time frame: 20 minutes). The study lists 3 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 NCT06529068, which also lists 9 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 10 Jun 2026.