NCT05003778

Brief Summary

The purpose of this project is to compare a minimal equipment training program with and without blood flow restriction (BFR) training to periodized concurrent resistance and endurance training. The outcomes of interest are Army Combat Fitness Test (ACFT) performance along with laboratory measures of performance, which include body composition, power, strength, and maximal aerobic capacity (VO2max). Additionally, based on the role of mechanical tension in connective tissue adaptation and the importance for chronic musculoskeletal health, tendon architecture will be assessed as well. Lastly, specific blood-based biomarkers will be analyzed in conjunction with questionnaires to determine the systemic physiological and psychological responses to training. Participants will be randomized into one of three training groups and will follow their respective program for 6 weeks. The three groups are traditional concurrent resistance and endurance training, minimal equipment training, and minimal equipment training with blood flow restriction (BFR).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2022

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

July 21, 2021

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Army Combat Fitness Test

    6-event task to assess various aspects of human performance (muscular power, muscular strength, muscular endurance, anaerobic capacity, and aerobic capacity). Tests include 3-repetition maximum trap-bar deadlift, standing power throw with 10-lb ball, 2-min hand-release push-ups, sprint-drag-carry, 2-min leg tucks, and 2-mile run.

    Baseline and Week 6

Secondary Outcomes (9)

  • Change in muscular power

    Baseline and Week 6

  • Change in muscular strength

    Baseline and Week 6

  • Change in aerobic capacity

    Baseline and Week 6

  • Change in body mass

    Baseline and Week 6

  • Change in body composition

    Baseline and Week 6

  • +4 more secondary outcomes

Study Arms (3)

Traditional equipment resistance and endurance training

ACTIVE COMPARATOR

Participants in this group undergo 6 weeks of concurrent resistance and endurance training using traditional equipment (i.e., power racks, barbells, dumbbells, etc.)

Other: Traditional equipment resistance training

Minimal equipment resistance and endurance training

EXPERIMENTAL

Participants in this group undergo 6 weeks of concurrent resistance and endurance training using minimal equipment (i.e., sandbags, resistance bands, suspension trainers, weight vests, etc.)

Other: Minimal equipment resistance training

Minimal equipment resistance and endurance training with blood flow restriction

EXPERIMENTAL

Participants in this group undergo 6 weeks of concurrent resistance and endurance training using minimal equipment (i.e., sandbags, resistance bands, suspension trainers, weight vests, etc.) while wearing upper- and lower-body blood-flow restriction cuffs

Other: Minimal equipment resistance trainingOther: Blood flow restriction training

Interventions

Participants will undergo 6 weeks of traditional equipment resistance training

Traditional equipment resistance and endurance training

Participants will undergo 6 weeks of minimal equipment resistance training

Minimal equipment resistance and endurance trainingMinimal equipment resistance and endurance training with blood flow restriction

Participants will undergo 6 weeks of blood flow restriction training

Minimal equipment resistance and endurance training with blood flow restriction

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females between the ages of 18 and 35 (inclusive) and enrolled in an ROTC program.
  • Subject has provided written and dated informed consent to participate in the study.
  • Subject is in good health as determined by medical history and is cleared for exercise.
  • Subject will be asked about dietary supplementation use within the past 6 months.
  • If subject began taking a supplement within the past month, subject will be asked to discontinue supplement use followed by a 2-week washout prior to participation.
  • In all other cases, we will request that subjects maintain supplement use.

You may not qualify if:

  • Subjects with any musculoskeletal injuries that would prevent exercising.
  • Subjects with any metabolic disorder including known electrolyte abnormalities, diabetes, thyroid disease, adrenal disease or hypogonadism.
  • Subjects with any inborn error of metabolism.
  • Subjects with a history of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
  • Subjects with a personal history of heart disease, high blood pressure (systolic \>140 mm Hg \& diastolic \>90 mm Hg), psychiatric disorders, cancer, benign prostate hypertrophy, gastric ulcer, reflux disease, or any other medical condition deemed ineligible to participate in physical training by the ROTC athletic trainers or ROTC medical staff.
  • Subjects currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or anti-coagulant medications.
  • Subjects who are pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina Sport Science Lab

Columbia, South Carolina, 29201, United States

Location

Related Publications (1)

  • Cintineo HP, Chandler AJ, Mastrofini GF, Lints BS, McFadden BA, Arent SM. Effects of Minimal-Equipment Resistance Training and Blood Flow Restriction on Military-Relevant Performance Outcomes. J Strength Cond Res. 2024 Jan 1;38(1):55-65. doi: 10.1519/JSC.0000000000004596.

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair

Study Record Dates

First Submitted

July 21, 2021

First Posted

August 12, 2021

Study Start

November 20, 2020

Primary Completion

March 4, 2022

Study Completion

June 29, 2022

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations