Effects of Blood Flow Restriction During Eccentric Resistance Exercise

November 3, 2022 updated by: Brennan Thompson, Utah State University

Effects of Blood Flow Restriction During Multiple-joint Eccentric Resistance Training on Muscle Morphology and Function of the Lower Body

The purpose of this study is to compare the muscle strength and muscle soreness effects experienced following short term (acute) eccentric exercise with and without blood flow restriction (BFR) performed at low - moderate training intensities.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

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.
45

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 Contact Backup

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

14 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Exclusion Criteria:

  • lower body surgery or injury in the last 12 months
  • have any neuromuscular disease
  • height >76 inches tall
  • height <54 inches tall
  • eccentric strength greater than 725 pounds
  • pregnant or plan to be pregnant in the duration of the protocol
  • don't do resistance exercise at least once per week
  • perform intense cardio or strength training >4 days per week
  • Present with any other significant comorbid conditions that would impair the ability to participate in the exercise-based testing

Inclusion criteria:

  • 18 - 30 years old
  • strength train lower body 1-3 times per week

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Active Comparator: Eccentric exercise
Only multi-joint eccentric exercise
Device: Eccentric exercise / Eccentric exercise with blood flow restriction
Individuals will be randomized to receive eccentric exercise only, or eccentric exercise with blood flow restriction.
Experimental: Eccentric training with blood flow restriction
Multi-joint eccentric exercise with blood flow restriction
Device: Eccentric exercise / Eccentric exercise with blood flow restriction
Individuals will be randomized to receive eccentric exercise only, or eccentric exercise with blood flow restriction.

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
visual analog scale (soreness)
Time Frame: Baseline (pretest)
soreness
Baseline (pretest)
visual analog scale (soreness)
Time Frame: immediately post exercise
soreness
immediately post exercise
visual analog scale (soreness)
Time Frame: 24 hours post exercise
soreness
24 hours post exercise
visual analog scale (soreness)
Time Frame: 48 hours post exercise
soreness
48 hours post exercise
visual analog scale (soreness)
Time Frame: 72 hours post exercise
soreness
72 hours post exercise
force algometer (soreness)
Time Frame: Baseline (pretest)
soreness
Baseline (pretest)
force algometer (soreness)
Time Frame: immediately post exercise
soreness
immediately post exercise
force algometer (soreness)
Time Frame: 24 hours post exercise
soreness
24 hours post exercise
force algometer (soreness)
Time Frame: 48 hours post exercise
soreness
48 hours post exercise
force algometer (soreness)
Time Frame: 72 hours post exercise
soreness
72 hours 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
Eccentric muscle strength
Time Frame: Baseline (pretest)
muscle strength will be assessed on the Eccentron.
Baseline (pretest)
Eccentric muscle strength
Time Frame: immediately post exercise
muscle strength will be assessed on the Eccentron.
immediately post exercise
Eccentric muscle strength
Time Frame: 24 hours post exercise
muscle strength will be assessed on the Eccentron.
24 hours post exercise
Eccentric muscle strength
Time Frame: 48 hours post exercise
muscle strength will be assessed on the Eccentron.
48 hours post exercise
Eccentric muscle strength
Time Frame: 72 hours post exercise
muscle strength will be assessed on the Eccentron.
72 hours post exercise
Single-leg hop
Time Frame: Baseline (pretest)
3 single-leg hops per limb
Baseline (pretest)
Single-leg hop
Time Frame: immediately post exercise
3 single-leg hops per limb
immediately post exercise
Single-leg hop
Time Frame: 24 hours post exercise
3 single-leg hops per limb
24 hours post exercise
Single-leg hop
Time Frame: 48 hours post exercise
3 single-leg hops per limb
48 hours post exercise
Single-leg hop
Time Frame: 72 hours post exercise
3 single-leg hops per limb
72 hours 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.
Utah 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: Brennan Thompson, PhD, Utah State University

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 (Anticipated)

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 1, 2023

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.
December 1, 2023

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.
March 1, 2024

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).
October 13, 2022

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.
November 3, 2022

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.
November 7, 2022

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.
November 7, 2022

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.
November 3, 2022

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.
November 1, 2022

More Information

Terms related to this study

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.
  • 12042a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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