Upper- and Lower-body Resistance Exercise With and Without Blood Flow Restriction on Hemodynamics and Vascular Function

July 20, 2017 updated by: J. Derek Kingsley, Kent State University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will come to the Cardiovascular Dynamics Laboratory at Kent State University for 4 separate visits. On the first visit, participants will undergo an orientation and decide if they want to sign the informed consent. If they decide to consent, they will be assigned randomly to either upper- or lower-body group, and fill out Physical Activity Readiness Questionnaire (PAR-Q) and Health Participant Questionnaire then be measured for height, weight, body composition (7-sites skin fold), arterial occlusion pressure (determine the pressure that occlude blood flow using a doppler device on brachial or femoral artery, and a 13-cm nylon cuff at the proximal end of right arm or right leg then inflate the cuff to 50 mmHg and increases by 1 mmHg per second until the doppler device cannot detect blood flow) and 1 RM which they will move maximum amount of weight 1 time through a full range of motion on the chess press and latissimus dorsi pulldown or knee extension and knee flexion. A certified strength and conditioning specialist will adjust the form, spot the lifts, and provide feedback if needed. The second visit consists of 1-repetition maximum verification that participants will be measured 1-repetition maximum on the chess press and latissimus dorsi pulldown or knee extension and knee flexion again to ensure their maximal strength. For the third and fourth visits, the participants will come to the Cardiovascular Dynamics Laboratory to have their responses to either acute upper- or lower-body resistance exercise with and without BFR quantified. Participants will arrive at the laboratory having avoided caffeine, alcohol, and strenuous exercise for 24 hours, and at least 3 hours without food before data collection. Participants will have their hemodynamics and vascular function measured before and after either acute upper- or lower-body resistance exercise with or without BFR. Hemodynamic measurements will include pulse wave analysis (PWA) using a SphygmoCor (AtCor Medical, Sydney, Australia) device. Heart rate and blood pressure will be monitored using 3 leads electrocardiograph (ECG) and on the middle finger of the right hand, respectively. A 5-minute ECG will be collected, and participants will be breathing with a metronome at the rate of 12 breaths/minute. PWA provides information about aortic and brachial systolic and diastolic BP, as well as measures of wave reflection that give insight into central arterial modulation such as augmentation pressure and the augmentation index. BP will be measured twice separated by 1 minute by an oscillometric device. After that the investigators will assess vascular function via pulse wave velocity. During PWA measurements, there will be cuffs on right arm and right leg, and a tonometer will be placed on the carotid artery on the neck. Peripheral arterial mechanics will be measured by strain gauge plethysmography (EC-6; DE Hokanson Inc., Bellevue, WA, USA) on the forearm close to the elbow in order to determine forearm blood flow and vasodilatory capacity (peak blood flow). There will be cuffs on the upper left arm and on the left wrist. The wrist Cuff will be inflated to 220 mmHg 1 minute prior to data collection and throughout. The Upper arm cuff will be inflated to 50 mmHg to occlude venous flow for measurement of arterial flow. Ninety seconds of measurement of flow will occur. Once this is completed, the cuff on the upper arm will be inflated to 220 mmHg for 5 minutes to occlude blood flow. After that, the pressure in the cuff will be released and measurements of blood flow will be taken for the next 3 minutes with the wrist cuff will be inflated to 220 mmHg 1 minute prior to data collection and throughout. The upper-(chess press and latissimus dorsi pulldown) and lower-body (knee extension and knee flexion) resistance exercise with BFR will consists of 4 sets of 30, 15, 15, and 15 repetitions at 30% 1 RM with 30 seconds rest between sets and 2 minutes rest between exercises. The upper- and lower-body resistance exercise without BFR will consists of 4 sets of 8 repetitions at 70% 1 RM with 60 seconds rest between sets and 2 minutes rest between exercises. Participants' arms or legs will be wrapped using elastic cuffs at the most proximal limbs. At 40% of arterial occlusion pressure will be used to induce BFR. Three minutes warm up and three minutes cool down on the cycle ergometer will be given before and after resistance exercise. Immediately after completion of the acute bouts of resistance exercise, the investigators will assess PWA and ECG at 10, 20, 30, 40, 50, and 60 minutes post exercise, and BF at 20 and 60 minutes post exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Kent, Ohio, United States, 44242
        • Recruiting
        • Cardiovascular Dynamics Laboratory
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 3 days per week of resistance training for 1 year
  • 18-30 years of age

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Resistance Exercise with Blood flow restriction
Subjects will perform 4 sets with 30, 15, 15, 15 repetitions at 30% 1RM.
Other: Resistance Exercise with Blood Flow Restriction
A cuff will be used to restrict blood flow to the extremities.
Other Names:
  • KATTSU
ACTIVE_COMPARATOR: High-intensity resistance exercise
Subjects will perform 4 sets of 8 repetitions at 70% 1RM.
Other: High-intensity Resistance Exercise
Participants will follow a conventional resistance exercise regime.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Autonomic Modulation over 1 hour
Time Frame: Rest, 10 min, 20 min, 30 min, 40 min, 50 min, 60 min post exercise
Heart rate variability
Rest, 10 min, 20 min, 30 min, 40 min, 50 min, 60 min post exercise

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Endothelial Function over 1 hour
Time Frame: Rest, 10 min, 20 min, 30 min, 40 min, 50 min, 60 min post exercise
Pulse wave velocity
Rest, 10 min, 20 min, 30 min, 40 min, 50 min, 60 min post exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kent State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: J. Derek Kingsley, PhD, Kent State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-285

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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