NCT06529068

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

December 2, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

July 18, 2024

Last Update Submit

June 11, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Systolic blood pressure and diastolic blood pressure

    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

    Brachial artery diameter will be measured by an ultrasound machine to calculate flow-mediated dilation (FMD)

    Before and 20 minutes after exercise

  • Heart rate

    Monitor heart rate continuously before, during, and after exercise

    20 minutes

Study Arms (3)

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

Interventions

The participants will perform isometric handgrip exercises without blood flow restriction.

Isometric exercise without BFR cuff (control)

The participants will perform isometric handgrip exercises with blood flow restriction using a narrow-elastic band.

Isometric exercise with narrow-elastic BFR band

The participants will perform isometric handgrip exercises with blood flow restriction using a wide-rigid cuff.

Isometric exercise with wide-rigid BFR cuff

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Apparently healthy young adults aged between 18 - 40 years old and signed the informed consent.

You may not qualify if:

  • 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
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Aging Research Laboratory

Austin, Texas, 78712-1415, United States

Location

Related Publications (9)

  • 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.

    PMID: 5412979BACKGROUND
  • 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.

    PMID: 30086274BACKGROUND
  • 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.

    PMID: 30208794BACKGROUND
  • 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.

    PMID: 37348015BACKGROUND
  • 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.

    PMID: 34823439BACKGROUND
  • 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.

    PMID: 19952840BACKGROUND
  • 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.

    PMID: 33344005BACKGROUND
  • 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.

    PMID: 20019641BACKGROUND
  • 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.

    PMID: 29864505BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2024

First Posted

July 31, 2024

Study Start

December 2, 2024

Primary Completion

May 30, 2025

Study Completion

May 30, 2025

Last Updated

June 12, 2025

Record last verified: 2025-06

Locations