NCT05586451

Brief Summary

Blood flow restricted (BFR) resistance exercise has been shown to improve skeletal muscle adaptations to low load resistance exercise. One of many adaptations with resistance training is neural adaptations that occur within the first few weeks of resistance training. It has been hypothesized that these neural adaptations are blunted when using blood flow restricted exercise. Therefore, the investigators propose to examine the muscle activation created by resistance exercise with different intensities with blood flow restriction and without blood flow restriction in sedentary compared to resistance-trained individuals. The investigators will recruit and completely study up to 30, previously untrained and resistance-trained, healthy, college-aged (18-40 years) males. Participants will come in the laboratory for 5 total visits. These visits will consist of a screening/familiarization visit, a strength testing visit, and 3 acute exercise visits. The acute exercise visits will consist of 2 blood flow restricted resistance sessions at different intensities and a traditional high load resistance exercise session. The 3 acute exercise visits will be randomized. The investigators will measure muscle mass (appendicular lean mass) using Dual Energy X-Ray Absorptiometry, muscle strength and endurance using isotonic and isokinetic testing, and muscle activation using surface electromyography. The investigators will also use near infrared spectroscopy (NIRS) to measure the muscle tissue (oxygen) saturation index (TSI) in the vastus lateralis during exercise. Finally, the investigators will also draw blood before and after each exercise session to measure hormones, metabolites, and markers of inflammation using commercially available assays (e.g., ELISAs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

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

Study Start

First participant enrolled

July 5, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 19, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

August 1, 2022

Last Update Submit

September 10, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Muscle Activation Measured During Traditional High Load Resistance Exercise (HLRE)

    Muscle (vastus lateralis) activation will be measured using surface EMG, during the knee extension exercises conducted during the acute HLRE bout.

    Measurement will occur during the acute bout HLRE, which will occur during the HLRE study visit.

  • Low Load Resistance Exercise with Blood Flow Restriction (LLBFR)

    Muscle (vastus lateralis) activation will be measured using surface EMG, during the knee extension exercises conducted during the acute LLBFR bout.

    Measurement will occur during the acute bout LLBFR, which will occur during the LLBFR study visit.

  • Moderate Load Resistance Exercise with Blood Flow Restriction (MLBFR)

    Muscle activation (vastus lateralis) will be measured using surface EMG, during the knee extension exercises conducted during the acute MLBFR bout.

    Measurement will occur during the acute bout MLBFR, which will occur during the MLBFR study visit.

Secondary Outcomes (3)

  • Change in Maximal Voluntary Contraction following HLRE

    Measurements will be conducted before and immediately following the completion of the HLRE bout.

  • Change in Maximal Voluntary Contraction following LLBFR

    Measurements will be conducted before and immediately following the completion of the LLBFR bout.

  • Change in Maximal Voluntary Contraction following MLBFR

    Measurements will be conducted before and immediately following the completion of the MLBFR bout.

Study Arms (2)

Resistance Trained

OTHER

Resistance-trained individuals are considered those who report performing structured moderate to intense resistance exercise for at least three days per week for at least 2 years prior to study start.

Behavioral: Traditional High Load Resistance Exercise (HLRE)Behavioral: Low Load Resistance Exercise with Blood Flow Restriction (LLBFR)Behavioral: Moderate Load Resistance Exercise with Blood Flow Restriction (MLBFR)

Untrained

OTHER

Untrained individuals are considered those that report less than two days per week of structured (\> 30 minutes) moderate to vigorous-intensity aerobic exercise and less than two days per week of structured resistance training for the 3 months prior to study start.

Behavioral: Traditional High Load Resistance Exercise (HLRE)Behavioral: Low Load Resistance Exercise with Blood Flow Restriction (LLBFR)Behavioral: Moderate Load Resistance Exercise with Blood Flow Restriction (MLBFR)

Interventions

Participants will then perform 75% of tested 1RM for 3 sets of 12 repetitions at a pace of 1 repetition every 2 seconds on the dominant leg with one-minute rest between sets. After completing the HLRE protocol, participants will perform 2 post-exercise maximal voluntary contractions.

Resistance TrainedUntrained

Participants will then perform 25% of tested 1RM for sets of 30, 15, 15, and 15 repetitions on the dominant leg at a pace of 1 repetition every 2 seconds with one-minute rest between sets. Participants will be fitted with an occlusion cuff on the proximal portion of the thigh. The limb occlusion pressure will be set at 60% blood flow occlusion and remain occluded throughout the exercise (Delfi Medical Innovations Personal Tourniquet System).

Resistance TrainedUntrained

Participants will then perform 50% of tested 1RM for sets of 15, 8, 7, and 7 repetitions on the dominant leg at a pace of 1 repetition every 2 seconds with one-minute rest between sets. Participants will be fitted with an occlusion cuff on the proximal portion of the thigh. The limb occlusion pressure will be set at 60% blood flow occlusion and remain occluded throughout the exercise (Delfi Medical Innovations Personal Tourniquet System).

Resistance TrainedUntrained

Eligibility Criteria

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

You may qualify if:

  • Capable and willing to give written informed consent

You may not qualify if:

  • years of age
  • A waist circumference \< 40 inches.
  • No medical condition that would limit their participation in supervised exercise sessions based on the Physical Activity Readiness Questionnaire for Everyone (PARQ+)
  • No current prescription medications
  • Willing to allow researchers to use data and images (e.g., Dual Energy X-Ray Absorptiometry) for research purposes after study participation is completed
  • Either untrained or resistance-trained by the following definitions: Untrained individuals are considered those that report less than two days per week of structured (\> 30 minutes) moderate to vigorous-intensity aerobic exercise and less than two days per week of structured resistance training for the 3 months prior to study start. Resistance-trained individuals are considered those who report performing structured moderate to intense resistance exercise for at least three days per week for at least 2 years prior to study start.
  • Self-report history of diabetes mellitus
  • Self-report history of cardiovascular, peripheral vascular, cerebral vascular, pulmonary, or renal disease
  • Self-report or evidence of uncontrolled hypertension \> 150/85 (or measured)
  • Self-report history of blood clotting disorders
  • Self-report history of deep vein thrombosis or pulmonary embolism
  • Self-report history of sickle cell trait
  • Self-report history of varicose veins
  • Self-report history of a myopathy leading to muscle loss, weakness, severe cramps or myalgia
  • Self-report history of orthopedic limitations that would preclude them from participation in a dynamic exercise program
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lousiana State University

Baton Rouge, Louisiana, 70803, United States

Location

Study Officials

  • Brian A Irving

    School of Kinesiology

    PRINCIPAL INVESTIGATOR

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
Associate Professor

Study Record Dates

First Submitted

August 1, 2022

First Posted

October 19, 2022

Study Start

July 5, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations