Minimal Equipment Training Approach to Improve Warfighter Performance

November 27, 2023 updated by: Shawn M. Arent, University of South Carolina

The Effects of a Minimal Equipment Training Approach Compared to Concurrent Training to Improve Warfighter Health and Performance

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Detailed Description

The efficacy of minimal equipment training programs with an emphasis on resistance training has seldom been assessed and compared to traditional strength training. Common training strategies include traditional high-to-moderate load resistance training and low-to-moderate load field training using minimal equipment. The benefit of traditional CT is likely due to the higher loads relative to 1-repetition maximum (1RM) utilized and overall amount of mechanical stress incurred. It is difficult to mimic this loading with minimal equipment training, which is often performed at low loads relative to 1RM. However, one strategy to improve the effectiveness of minimal equipment training may be the addition of blood flow restriction (BFR) training. Due to the relatively low loads (20-70% 1RM) of minimal equipment training, BFR training not only provides athletes with a novel training modality to elicit hypertrophic and strength adaptation but also to augment recovery as a supplemental low-damage, high-volume training method. The research design will allow for the direct comparison of minimal equipment training with and without additional BFR training to periodized CT with regard to changes in outcomes, in particular, ACFT performance.

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 (Actual)

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.
54

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 Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • University of South Carolina Sport Science Lab

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: Traditional equipment resistance and endurance training
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
Participants will undergo 6 weeks of traditional equipment resistance training
Experimental: Minimal equipment resistance and endurance training
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
Participants will undergo 6 weeks of minimal equipment resistance training
Experimental: Minimal equipment resistance and endurance training with blood flow restriction
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 training
Participants will undergo 6 weeks of minimal equipment resistance training
Other: Blood flow restriction training
Participants will undergo 6 weeks of blood flow restriction training

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
Change in Army Combat Fitness Test
Time Frame: Baseline and Week 6
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 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
Change in muscular power
Time Frame: Baseline and Week 6
Assessed via countermovement vertical jump height.
Baseline and Week 6
Change in muscular strength
Time Frame: Baseline and Week 6
Assessed via 3-repetition maximum bench press.
Baseline and Week 6
Change in aerobic capacity
Time Frame: Baseline and Week 6
Assessed via treadmill-based maximal graded exercise test with indirect calorimetry.
Baseline and Week 6
Change in body mass
Time Frame: Baseline and Week 6
Body mass via calibrated scale.
Baseline and Week 6
Change in body composition
Time Frame: Baseline and Week 6
Body fat percentage, fat-free mass, and fat mass via air-displacement plethysmography.
Baseline and Week 6
Change in muscle and tendon thickness
Time Frame: Baseline and Week 6
Biceps brachii and quadriceps muscle thickness via B-mode ultrasound and distal biceps tendon and quadriceps tendon via B-mode ultrasound.
Baseline and Week 6
Change in blood-based biomarkers
Time Frame: Baseline and Week 6
Basal hormonal and biochemical assessments. Cortisol, interleukin (IL)-6, IL-10, IL-1β, growth hormone (GH), and insulin-like growth factor-1 (IGF-1).
Baseline and Week 6
Change in blood lactate responses
Time Frame: Baseline, Week 3, and Week 6
Biochemical responses to exercise. Blood lactate sampled pre-, mid-, and post-exercise during training sessions in weeks 1, 3, and 6.
Baseline, Week 3, and Week 6
Change in training distress
Time Frame: Baseline and every subsequent week through Week 6
Overall training distress and subscales including depressed moods, vigor, physical signs and symptoms, sleep disturbances, perceived stress, and general fatigue. The Multicomponent Training Distress Scale will be administered weekly.
Baseline and every subsequent week through Week 6

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.
University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense

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 (Actual)

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.
November 20, 2020

Primary Completion (Actual)

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.
March 4, 2022

Study Completion (Actual)

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.
June 29, 2022

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).
July 21, 2021

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.
August 11, 2021

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.
August 12, 2021

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 29, 2023

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 27, 2023

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, 2023

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.
  • Pro00103649

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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