- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06529068
Cardiovascular Response to Isometric BFR Exercise
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78712-1415
- Cardiovascular Aging Research Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Apparently healthy young adults aged between 18 - 40 years old and signed the informed consent.
Exclusion Criteria:
- Abnormal clotting times
- Acid-base imbalance/acidosis
- Arterial calcification
- Atherosclerotic vessels
- Cardiopulmonary conditions
- Diabetes
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Isometric exercise without BFR cuff (control)
|
The participants will perform isometric handgrip exercises without blood flow restriction.
|
|
Experimental: Isometric exercise with narrow-elastic BFR band
|
The participants will perform isometric handgrip exercises with blood flow restriction using a narrow-elastic band.
|
|
Experimental: Isometric exercise with wide-rigid BFR cuff
|
The participants will perform isometric handgrip exercises with blood flow restriction using a wide-rigid cuff.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
20 minutes
|
|
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)
|
Before and 20 minutes after exercise
|
|
Heart rate
Time Frame: 20 minutes
|
Monitor heart rate continuously before, during, and after exercise
|
20 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Credeur 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.
- Early 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.
- 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.
- Domingos 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.
- Bond 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.
- Mannozzi 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.
- Song 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.
- Renzi 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.
- Schneider 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.
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00006378
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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