NCT03225898

Brief Summary

The American College of Sports Medicine (ACSM) recommends that resistance exercise performed at greater than 70% one repetition maximum (1 RM) is necessary to induce strength gains and muscular hypertrophy (ACSM, 2009). However, previous work has shown resistance exercise at high intensity increases the rate of injury. Blood flow restriction (BFR) exercise is a method that is used to compress the blood vessels to the exercising muscle in order to reduce blood flow to the limb with the use of low-intensity resistance. Researchers have suggested that resistance exercise at intensities as low as 20-30% 1-repetition maximum with BFR increases in muscle mass, muscular endurance, and gains in strength. However, the acute heart and blood vessel changes in response to BFR are not clear. Work by our laboratory (Tai et al., 2016) has demonstrated that immediately following acute resistance exercise at moderate intensity (75% 1 RM) without BFR, there are no changes in aortic and brachial systolic and diastolic blood pressure (BP), but there are increases in the pressure of the reflective wave (augmentation pressure). This suggests that the arterial wall is stiff, and may in turn result in thickening of the arterial wall. However, the data are limited and these responses may not be universally accepted. In addition, these studies used primarily lower-body resistance exercises (squat, leg extension, and leg flexion), and did not assess changes in heart and blood vessel function. Previous researchers have demonstrated that upper-body exercise induces higher BP and heart rate (HR) than lower-body exercise. However, the effects of upper- and lower-body resistance exercise with BFR on heart and blood vessel function are still unclear. Therefore, understanding the effects of upper- and lower-body resistance exercise with BFR on heart and blood vessel function using weight machines, specifically the chess press, latissimus dorsi pulldown, knee extension, and knee flexion may significant impact how the resistance training program is prescribed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 14, 2017

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2018

Completed
Last Updated

July 24, 2017

Status Verified

July 1, 2017

Enrollment Period

12 months

First QC Date

July 10, 2017

Last Update Submit

July 20, 2017

Conditions

Keywords

blood flow restrictionresistance exercise

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Autonomic Modulation over 1 hour

    Heart rate variability

    Rest, 10 min, 20 min, 30 min, 40 min, 50 min, 60 min post exercise

Secondary Outcomes (1)

  • Change from Baseline Endothelial Function over 1 hour

    Rest, 10 min, 20 min, 30 min, 40 min, 50 min, 60 min post exercise

Study Arms (2)

Resistance Exercise with Blood flow restriction

EXPERIMENTAL

Subjects will perform 4 sets with 30, 15, 15, 15 repetitions at 30% 1RM.

Other: Resistance Exercise with Blood Flow Restriction

High-intensity resistance exercise

ACTIVE COMPARATOR

Subjects will perform 4 sets of 8 repetitions at 70% 1RM.

Other: High-intensity Resistance Exercise

Interventions

A cuff will be used to restrict blood flow to the extremities.

Also known as: KATTSU
Resistance Exercise with Blood flow restriction

Participants will follow a conventional resistance exercise regime.

High-intensity resistance exercise

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • days per week of resistance training for 1 year
  • years of age

You may not qualify if:

  • include a recent smoking history (\< 6 months)
  • obesity (defined as a body mass index ≥ 30 kg/m2)
  • skeletal and orthopedic injuries
  • cancer
  • known cardiovascular disease
  • open wounds
  • history of blood clots
  • metabolic disease
  • uncontrolled hypertension (resting brachial BP ≥ 140/90 mmHg)
  • pregnancy, planning to get pregnant
  • taking any medications or supplements known to affect blood pressure, heart rate, or vascular function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Dynamics Laboratory

Kent, Ohio, 44242, United States

RECRUITING

Related Publications (4)

  • Madarame H, Neya M, Ochi E, Nakazato K, Sato Y, Ishii N. Cross-transfer effects of resistance training with blood flow restriction. Med Sci Sports Exerc. 2008 Feb;40(2):258-63. doi: 10.1249/mss.0b013e31815c6d7e.

    PMID: 18202577BACKGROUND
  • Takarada Y, Sato Y, Ishii N. Effects of resistance exercise combined with vascular occlusion on muscle function in athletes. Eur J Appl Physiol. 2002 Feb;86(4):308-14. doi: 10.1007/s00421-001-0561-5.

    PMID: 11990743BACKGROUND
  • Rossow LM, Fahs CA, Sherk VD, Seo DI, Bemben DA, Bemben MG. The effect of acute blood-flow-restricted resistance exercise on postexercise blood pressure. Clin Physiol Funct Imaging. 2011 Nov;31(6):429-34. doi: 10.1111/j.1475-097X.2011.01038.x. Epub 2011 Jul 7.

    PMID: 21981453BACKGROUND
  • Figueroa A, Vicil F. Post-exercise aortic hemodynamic responses to low-intensity resistance exercise with and without vascular occlusion. Scand J Med Sci Sports. 2011 Jun;21(3):431-6. doi: 10.1111/j.1600-0838.2009.01061.x. Epub 2010 Jan 31.

    PMID: 20136757BACKGROUND

MeSH Terms

Conditions

Primary Dysautonomias

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System Diseases

Study Officials

  • J. Derek Kingsley, PhD

    Kent State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

J. Derek Kingsley, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 10, 2017

First Posted

July 21, 2017

Study Start

June 14, 2017

Primary Completion

June 13, 2018

Study Completion

June 13, 2018

Last Updated

July 24, 2017

Record last verified: 2017-07

Locations