NCT04938947

Brief Summary

The primary purposes of the proposed study is 1) To examine the changes of muscle fiber cross-sectional areas in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction and 2) To examine changes in motor unit size (a non-invasive measure of muscle fiber size) in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 22, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

June 22, 2021

Last Update Submit

October 31, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Determine changes in muscle fiber cross-sectional area

    A primary purpose of the study is to examine the changes of muscle fiber cross-sectional areas in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction

    July 2021-May 2022

  • Determine changes in motor unit size

    Another primary purpose of the study is to examine changes in motor unit size (a non-invasive measure of muscle fiber size) in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction

    July 2021- May 2022

Study Arms (2)

High-Intensity Resistance Training Group

EXPERIMENTAL

Participants in this group will complete 3 resistance training sessions per week for 6 weeks (18 sessions total). During each resistance training session, participants will perform 3 sets of bilateral leg-extensions (performed with both legs) to volitional failure (likely 8-12 repetitions) using 80% of their 1-repetition maximum (the most weight they are able to perform 1 complete repetition with, but not 2).

Other: High-Intensity Resistance Training

Low-Intensity Resistance Training with Blood Flow Restriction Group

EXPERIMENTAL

Participants in this group will complete 3 resistance training sessions per week for 6 weeks (18 sessions total). During each training session, participants will perform 3 sets of bilateral leg-extensions (performed with both legs) to volitional failure using 30% of their 1-repetition maximum (the most weight they are able to perform 1 complete repetition with, but not 2). Participants in this group will perform all leg extensions with blood flow restriction cuffs applied to the proximal thigh of both legs. The pressure that the cuffs are inflated to will be calculated based on estimates of each subject's arterial occlusion pressure from their thigh circumference. Once the target pressure is reached, the cuffs will not be deflated until after the final set of the training session.

Device: Blood Flow Restriction CuffsOther: Low-Intensity Resistance Training

Interventions

This intervention consists of inflatable cuffs that are designed to partially occlude veinous blood return from the lower extremities during resistance training.

Also known as: Blood Flow Occlusion Cuffs
Low-Intensity Resistance Training with Blood Flow Restriction Group

This intervention consists of performing low-intensity bilateral (both legs at the same time) leg extensions using 30% of a participants 1 repetition maximum (the maximum weight an individual can complete 1 repetition with, but not 2) to volitional failure.

Low-Intensity Resistance Training with Blood Flow Restriction Group

This intervention consists of performing high-intensity bilateral (both legs at the same time) leg extensions using 80% of a participants 1 repetition maximum (the maximum weight an individual can complete 1 repetition with, but not 2) to volitional failure.

High-Intensity Resistance Training Group

Eligibility Criteria

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

You may not qualify if:

  • Participants must not have participated in resistance training more than 5 times in the 6 months preceding the study.
  • Participants must be healthy and free of any cardiovascular, metabolic or musculoskeletal conditions that may affect the results of the investigation.
  • Participants must not have a history of severe hip, knee and/or ankle injuries, or any other pathological conditions that impair their motor control.
  • Participants must not have any pre-existing cardiovascular conditions that involve blood flow/blood clotting.
  • Participants who are currently taking blood thinners or any medications regulating blood pressures or heart rate will not be eligible to participate in the study.
  • Female participants who are pregnant at the start of or who are planning to become pregnant during the resistance training intervention will not be eligible to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robinson Center

Lawrence, Kansas, 66045, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Teaching Assistant

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 25, 2021

Study Start

September 22, 2021

Primary Completion

February 15, 2022

Study Completion

February 15, 2022

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations