NCT03723226

Brief Summary

Blood flow restricted (BFR) exercise has been shown to improve skeletal muscle adaptations to resistance exercise. BFR uses blood pressure cuffs (i.e., tourniquets) to reduce skeletal muscle blood flow during resistance exercise. One benefit of BFR is that skeletal muscle adaptations to resistance exercise training including muscle hypertrophy and increases in strength can be achieved at lower-loads (e.g., 25-30% 1RM), that are often comparable to more traditional resistance training loads (70-85% 1RM). However, the impact that low-load BFR resistance exercise has on muscle quality and bioenergetics is unknown. The present study will examine the impact of 6 weeks of low-load, single-leg resistance exercise training with or without personalized BFR on measures of muscle mass, strength, quality, and mitochondrial bioenergetics. The investigators will recruit and study up to 30, previously sedentary, healthy, college-aged adults (18-40 years). The investigators will measure muscle mass using Dual Energy X-Ray Absorptiometry and muscle strength and endurance using isokinetic testing. The investigators will normalize knee extensor strength to lower limb lean mass to quantify muscle quality. The investigators will also use near infrared spectroscopy (NIRS) to measure mitochondrial oxidative capacity in the vastus lateralis. Finally, the investigators will measure markers of systemic inflammation and markers of muscle damage using commercially available ELISA assays.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 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

September 21, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 28, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

4.4 years

First QC Date

September 21, 2018

Last Update Submit

August 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in Mitochondrial Oxidative Capacity

    Changes in mitochondrial oxidative capacity will be measured using near infrared spectroscopy (NIRS).

    Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training).

Secondary Outcomes (3)

  • Changes in Muscle Mass measured by Dual Energy X-ray Absorptiometry

    Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)

  • Changes in Muscle Strength measured using Isokinetic Dynamometry

    Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)

  • Changes in Muscle Endurance measured using Isokinetic Dynamometry

    Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)

Study Arms (2)

Low Load Resistance Exercise

ACTIVE COMPARATOR

Subjects allocated to Low Load Resistance Exercise will undergo 6 weeks of single-legged low load (25%) resistance exercise. Their contralateral leg will serve as within subject control.

Behavioral: Low Load Resistance Exercise

Low Load Resistance Exercise + BFR

EXPERIMENTAL

Subjects allocated to Low Load Resistance Exercise + BFR will undergo 6 weeks of single-legged low load (25%) resistance exercise plus blood flow restriction. Their contralateral leg will serve as within subject control.

Behavioral: Low Load Resistance Exercise + BFR

Interventions

Subjects allocated to Low Load Resistance Exercise will undergo 6 weeks of single-legged low load (25%) resistance exercise. Subjects will then perform 4 sets of 30, 15, 15 and 15 repetitions at 25% of their 1RM for the single-legged leg press and single-legged knee extensions. Their contralateral leg will serve as within subject control.

Low Load Resistance Exercise

Subjects allocated to Low Load Resistance Exercise + BFR will undergo 6 weeks of single-legged low load (25%) resistance exercise with blood flow restriction (60% occlusion pressure). Subjects will then perform 4 sets of 30, 15, 15 and 15 repetitions at 25% of their 1RM for the single-legged leg press and single-legged knee extensions. Their contralateral leg will serve as within subject control.

Low Load Resistance Exercise + BFR

Eligibility Criteria

Age18 Years - 40 Years
Sexall
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 inclusive
  • Body Mass Index (BMI) between 18.5-30 kg/m2 inclusive
  • No medical condition that would limit their participation in supervised exercise training based on the Physical Activity Readiness Questionnaire for Everyone (PARQ+)
  • No current prescription medications, with the exception of birth control
  • Willing to allow researchers to use data, biospecimens (e.g., blood) and images (e.g., Dual Energy x-Ray Absorptiometry) for research purposes after study participation is completed
  • Evidence or self-report being pregnant, lactating, or anticipating becoming pregnant in the next year
  • Participation in resistance or aerobic exercise training \> 2 days per week within the 3 months prior to screening
  • Self-report of history of type 1 or 2 diabetes mellitus
  • Self-report history of cardiovascular, peripheral vascular, cerebral vascular, pulmonary, or renal disease
  • Self-report or evidence of uncontrolled hypertension
  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lousiana State University

Baton Rouge, Louisiana, 70803, United States

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Brian Irving, PhD

    Louisiana State University - 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
Assistant Professor

Study Record Dates

First Submitted

September 21, 2018

First Posted

October 29, 2018

Study Start

January 28, 2019

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

August 16, 2023

Record last verified: 2023-08

Locations